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500 result(s) for "Ambulatory Surgical Procedures - adverse effects"
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Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial
Optimum surgical intervention for low-grade haemorrhoids is unknown. Haemorrhoidal artery ligation (HAL) has been proposed as an efficacious, safe therapy while rubber band ligation (RBL) is a commonly used outpatient treatment. We compared recurrence after HAL versus RBL in patients with grade II–III haemorrhoids. This multicentre, open-label, parallel group, randomised controlled trial included patients from 17 acute UK NHS trusts. We screened patients aged 18 years or older presenting with grade II–III haemorrhoids. We excluded patients who had previously received any haemorrhoid surgery, more than one injection treatment for haemorrhoids, or more than one RBL procedure within 3 years before recruitment. Eligible patients were randomly assigned (in a 1:1 ratio) to either RBL or HAL with Doppler. Randomisation was computer-generated and stratified by centre with blocks of random sizes. Allocation concealment was achieved using a web-based system. The study was open-label with no masking of participants, clinicians, or research staff. The primary outcome was recurrence at 1 year, derived from the patient's self-reported assessment in combination with resource use from their general practitioner and hospital records. Recurrence was analysed in patients who had undergone one of the interventions and been followed up for at least 1 year. This study is registered with the ISRCTN registry, ISRCTN41394716. From Sept 9, 2012, to May 6, 2014, of 969 patients screened, 185 were randomly assigned to the HAL group and 187 to the RBL group. Of these participants, 337 had primary outcome data (176 in the RBL group and 161 in the HAL group). At 1 year post-procedure, 87 (49%) of 176 patients in the RBL group and 48 (30%) of 161 patients in the HAL group had haemorrhoid recurrence (adjusted odds ratio [aOR] 2·23, 95% CI 1·42–3·51; p=0·0005). The main reason for this difference was the number of extra procedures required to achieve improvement (57 [32%] participants in the RBL group and 23 [14%] participants in the HAL group had a subsequent procedure for haemorrhoids). The mean pain 1 day after procedure was 3·4 (SD 2·8) in the RBL group and 4·6 (2·8) in the HAL group (difference −1·2, 95% CI −1·8 to −0·5; p=0·0002); at day 7 the scores were 1·6 (2·3) in the RBL group and 3·1 (2·4) in the HAL group (difference −1·5, −2·0 to −1·0; p<0·0001). Pain scores did not differ between groups at 21 days and 6 weeks. 15 individuals reported serious adverse events requiring hospital admission. One patient in the RBL group had a pre-existing rectal tumour. Of the remaining 14 serious adverse events, 12 (7%) were among participants treated with HAL and two (1%) were in those treated with RBL. Six patients had pain (one treated with RBL, five treated with HAL), three had bleeding not requiring transfusion (one treated with RBL, two treated with HAL), two in the HAL group had urinary retention, two in the HAL group had vasovagal upset, and one in the HAL group had possible sepsis (treated with antibiotics). Although recurrence after HAL was lower than a single RBL, HAL was more painful than RBL. The difference in recurrence was due to the need for repeat bandings in the RBL group. Patients (and health commissioners) might prefer such a course of RBL to the more invasive HAL. NIHR Health Technology Assessment programme.
Otto Aufranc Award: A Multicenter, Randomized Study of Outpatient versus Inpatient Total Hip Arthroplasty
Background Length of stay after total hip arthroplasty (THA) has decreased over the last two decades. However, published studies that have examined same-day and early discharge protocols after THA have been done in highly selected patient groups operated on by senior surgeons in a nonrandomized fashion without control subjects. Questions/purposes The purpose of this study was to evaluate and compare patients undergoing THA who are discharged on the same day as the surgery (“outpatient,” less than 12-hour stay) with those who are discharged after an overnight hospital stay (“inpatient”) with regard to the following outcomes: (1) postoperative pain; (2) perioperative complications and healthcare provider visits (readmission, emergency department or physician office); and (3) relative work effort for the surgeon’s office staff. Methods A prospective, randomized study was conducted at two high-volume adult reconstruction centers between July 2014 and September 2015. Patients who were younger than 75 years of age at surgery, who could ambulate without a walker, who were not on chronic opioids, and whose body mass index was less than 40 kg/m 2 were invited to participate. All patients had a primary THA performed by the direct anterior approach with spinal anesthesia at a hospital facility. Study data were evaluated using an intention-to-treat analysis. A total of 220 patients participated, of whom 112 were randomized to the outpatient group and 108 were randomized to the inpatient group. Of the 112 patients randomized to outpatient surgery, 85 (76%) were discharged as planned. Of the remaining 27 patients, 26 were discharged after one night in the hospital and one was discharged after two nights. Of the 108 patients randomized to inpatient surgery with an overnight hospital stay, 81 (75%) were discharged as planned. Of the remaining 27 patients, 18 met the discharge criteria on the day of their surgery and elected to leave the same day, whereas nine patients stayed two or more nights. Results On the day of surgery, there was no difference in visual analog scale (VAS) pain among patients who were randomized to discharge on the same day and those who were randomized to remain in the hospital overnight (outpatient 2.8 ± 2.5, inpatient 3.3 ± 2.3, mean difference −0.5, 95% confidence interval [CI], −1.1 to 0.1, p = 0.12). On the first day after surgery, outpatients had higher VAS pain (at home) than inpatients (3.7 ± 2.3 versus 2.8 ± 2.1, mean difference 0.9, 95% CI, 0.3–1.5, p = 0.005). With the numbers available, there was no difference in the number of reoperations, hospital readmissions without reoperation, emergency department visits without hospital readmission, or acute office visits. At 4-week followup, there was no difference in the number of phone calls and emails with the surgeon’s office (outpatient: 2.4 ± 1.9, inpatient: 2.4 ± 2.2, mean difference 0, 95% CI, −0.5 to 0.6, p = 0.94). Conclusions Outpatient THA can be implemented in a defined patient population without requiring additional work for the surgeon’s office. Because 24% (27 of 112) of patients planning to have outpatient surgery were not able to be discharged the same day, facilities to accommodate an overnight stay should be available. Level of Evidence Level I, therapeutic study.
Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Sciatic Nerve for Postoperative Analgesia Following Ambulatory Foot Surgery, a Proof-of-Concept Study
Background and ObjectivesPercutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducing needle followed by the delivery of electric current. This modality has been reported to treat chronic pain as well as postoperative pain the day following knee surgery. However, it remains unknown if this analgesic technique may be used in ambulatory subjects following foot procedures beginning within the recovery room immediately following surgery, and with only short series of patients reported to date, the only available data are derived from strictly observational studies. The purposes of this proof-of-concept study were to demonstrate the feasibility of using percutaneous sciatic nerve PNS to treat postoperative pain following ambulatory foot surgery in the immediate postoperative period and provide the first available data from a randomized controlled study design to provide evidence of analgesic effect.MethodsPreoperatively, an electrical lead (SPRINT; SPR Therapeutics, Inc, Cleveland, Ohio) was percutaneously inserted posterior to the sciatic nerve between the subgluteal region and bifurcation with ultrasound guidance. Following hallux valgus osteotomy, subjects received 5 minutes of either stimulation or sham in a randomized, double-masked fashion followed by a 5-minute crossover period and then continuous stimulation until lead removal on postoperative days 14 to 28.ResultsDuring the initial 5-minute treatment period, subjects randomized to stimulation (n = 4) experienced a downward trajectory in their pain over the 5 minutes of treatment, whereas those receiving sham (n = 3) reported no such change until their subsequent 5-minute stimulation crossover. During the subsequent 30 minutes of stimulation, pain scores decreased to 52% of baseline (n = 7). Three subjects (43%) used a continuous popliteal nerve block for rescue analgesia during postoperative days 0 to 3. Overall, resting and dynamic pain scores averaged less than 1 on the numeric rating scale, and opioid use averaged less than 1 tablet daily with active stimulation. One lead dislodged, 2 fractured during use, and 1 fractured during intentional withdrawal.ConclusionsThis proof-of-concept study demonstrates that percutaneous sciatic nerve PNS is feasible for ambulatory foot surgery and suggests that this modality provides analgesia and decreases opioid requirements following hallux valgus procedures. However, lead dislodgement and fracture are concerns.Clinical Trial RegistrationThis study was registered at Clinicaltrials.gov, identifier NCT02898103.
Study on the effectiveness and safety of ciprofol in anesthesia in gynecological day surgery: a randomized double-blind controlled study
Backgroud ciprofol is a new type of intravenous anesthetic, which is a tautomer of propofol, with the characteristics of less injection pain, less respiratory depression and higher potency, but little clinical experience. The aim of this study was to observe the efficacy and safety of the application of ciprofol in ambulatory surgery anesthesia in gynecology. Methods 128 patients were selected to undergo gynecological day surgery under general anesthesia, and the patients were randomly divided into the ciprofol group and the propofol group, with 64 cases in each group. During anesthesia induction, the ciprofol group was infused at a time limit of 0.5 mg/kg for one minute, and the propofol group was infused at a time limit of 2 mg/kg for 1 min. The overall incidence of adverse events was the primary outcome for this study, while secondary outcomes included the success rate of anesthesia induction, the time of loss of consciousness, the time of awakening,top-up dose and frequency of use of rescue drugs. Results The overall incidence of adverse events was significantly lower in the ciprofol group compared with the propofol group (56.2% vs. 92.2%,P < 0.05). The success rate of anesthesia induction of ciprofol and propofol group was 100.0%. The time of loss of consciousness of the ciprofol group was longer than that of the propofol group (1.6 ± 0.4 min vs. 1.4 ± 0.2 min, P < 0.05). The time of awakening was not statistically significant (5.4 ± 2.8 min vs. 4.6 ± 1.6 min, P > 0.05). The number of drug additions and resuscitation drugs used were not statistically significant. Conclusions Compared with propofol, ciprofol had a similar anesthetic effect in gynecological ambulatory surgery, and the incidence of adverse events in the ciprofol group was lower.
Intravenous versus oral acetaminophen for pain and quality of recovery after ambulatory spine surgery: a randomized controlled trial
IntroductionAs ambulatory spine surgery increases, efficient recovery and discharge become essential. Multimodal analgesia is superior to opioids alone. Acetaminophen is a central component of multimodal protocols and both intravenous and oral forms are used. While some advantages for intravenous acetaminophen have been touted, prospective studies with patient-centered outcomes are lacking in ambulatory spine surgery. A substantial cost difference exists. We hypothesized that intravenous acetaminophen would be associated with fewer opioids and better recovery.MethodsPatients undergoing ambulatory spine surgery were randomized to preoperative oral placebo and intraoperative intravenous acetaminophen or preoperative oral acetaminophen. All patients received general anesthesia and multimodal analgesia. The primary outcome was 24-hour opioid use in intravenous morphine milligram equivalents (MMEs), beginning with arrival to the postanesthesia care unit (PACU). Secondary outcomes included pain, Quality of Recovery (QoR)-15 scores, postoperative nausea and vomiting, recovery time, and correlations between pain catastrophizing, QoR-15, and pain.ResultsA total of 82 patients were included in final analyses. Demographics were similar between groups. For the primary outcome, the median 24-hour MMEs did not differ between groups (12.6 (4.0, 27.1) vs 12.0 (4.0, 29.5) mg, p=0.893). Postoperative pain ratings, PACU MMEs, QoR-15 scores, and recovery time showed no differences. Spearman’s correlation showed a moderate negative correlation between postoperative opioid use and QoR-15.ConclusionIntravenous acetaminophen was not superior to the oral form in ambulatory spine surgery patients. This does not support routine use of the more expensive intravenous form to improve recovery and accelerate discharge.Trial registration number NCT04574778.
Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery
Background and ObjectivesWe examined whether liposome bupivacaine (Exparel) given in the interscalene brachial plexus block lowers pain in the setting of multimodal postoperative pain management for major shoulder surgery.MethodsFifty-two adult patients were randomized to receive either 5 mL of 0.25% bupivacaine HCl immediately followed by 10 mL of liposome bupivacaine 133 mg (n = 26) or 15 mL of 0.25% standard bupivacaine alone (n = 26) in interscalene brachial plexus block. The primary outcome (worst pain in the first postoperative week) was assessed by the Modified Brief Pain Inventory short form. Secondary outcomes were overall satisfaction with analgesia (OBAS), functionality of the surgical arm, sleep duration, time to first opioid (tramadol) request and opioid consumption (mEq), sensory-motor block characteristics, and the occurrence of adverse effects.ResultsWorst pain was lower in patients given liposome bupivacaine added to standard bupivacaine than in patients given standard bupivacaine alone (generalized estimating equation [GEE] estimated marginal mean values, 3.6 ± 0.3 vs 5.3 ± 0.4 points on the Numeric Rating Scale, respectively, although the effect was modest, 1.6 ± 0.5; 95% confidence interval, 0.8–2.5). Total OBAS scores indicated greater satisfaction (GEE estimated marginal mean values, 1.8 ± 0.3 vs 3.3 ± 0.4 on total OBAS, respectively, with modest effect, difference, 1.4 ± 0.5; 95% confidence interval, 0.5–2.4). There were no differences in any of the other secondary outcomes.ConclusionsLiposome bupivacaine added to standard bupivacaine may lower pain and enhance patient's satisfaction in the first postoperative week even in the setting of multimodal analgesia for major shoulder surgery.This study was registered with clinicaltrials.gov (NCT02554357) on July 11, 2015, by Principal Investigator Catherine Vandepitte, MD.
SAME day amBulatory c (SAMBA): a multicenter, prospective, randomized clinical trial protocol
A recent meta-analysis concluded that outpatient appendectomy appears feasible and safe, but there is a lack of high-quality evidence and a randomized trial is needed. The aim of this trial is to demonstrate that outpatient appendectomy is non-inferior to conventional inpatient appendectomy in terms of overall morbi-mortality on the 30th postoperative day (D30). SAMBA is a prospective, randomized, controlled, multicenter non-inferiority trial. We will include 1400 patients admitted to 15 French hospitals between January 2023 and June 2025. Inclusion criteria are patients aged between 15 and 74 years presenting acute uncomplicated appendicitis suitable to be operated by laparoscopy. Patients will be randomized to receive outpatient care (day-surgery) or conventional inpatient care with overnight hospitalization in the surgery department. The primary outcome is postoperative morbi-mortality at D30. Secondary outcomes include time from diagnosis to appendectomy, length of total hospital stay, re-hospitalization, interventional radiology, re-interventions until D30, conversion from outpatient to inpatient, and quality of life and patient satisfaction using validated questionnaires. The SAMBA trial tests the hypothesis that outpatient surgery (i.e., without an overnight hospital stay) of uncomplicated acute appendicitis is a feasible and reliable procedure in establishments with a technical platform able to support this management strategy. ClinicalTrials.gov NCT05691348. Registered on 20 January 2023.
Comparison of 2-Chloroprocaine, Bupivacaine, and Lidocaine for Spinal Anesthesia in Patients Undergoing Knee Arthroscopy in an Outpatient Setting: A Double-Blind Randomized Controlled Trial
Background and ObjectivesKnee arthroscopy is a well-established procedure in day-case surgery, which is frequently performed under spinal anesthesia. It is, however, controversial whether the choice for a specific local anesthetic translates into relevant outcomes. We hypothesized that the use of 2-chloroprocaine would be associated with a faster recovery from sensorimotor block.MethodsNinety-nine patients were included in this prospective, double-blind, randomized controlled trial and randomly allocated to receive either 40 mg 2-chloroprocaine, 40 mg lidocaine, or 7.5 mg bupivacaine. The primary endpoint was the time until complete recovery of sensory block. Secondary endpoints included time to recovery from motor block, failure rates, incidence of hypotension/bradycardia, postoperative pain, first mobilization, voiding and discharge times, and the incidence of transient neurologic symptoms. This clinical trial was registered prior to patient enrollment (EudraCT 2011-003675-11).ResultsPatients in the chloroprocaine group had a significantly shorter time until recovery from sensory block (median, 2.6 hours; interquartile range [IQR], 2.2–2.9 hours) than patients in the lidocaine group (3.1 hours; IQR, 2.7–3.6 hours; P < 0.006) and in the bupivacaine group (6.1 hours; IQR, 5.5 hours to undefined hours; P < 0.0001). Chloroprocaine was associated with a significantly faster recovery from motor block than lidocaine and bupivacaine. Times to first mobilization, voiding, and discharge were significantly shorter for chloroprocaine when compared with bupivacaine, but not with lidocaine. In the bupivacaine group, patients needed significantly less rescue medication for postoperative pain when compared with lidocaine and chloroprocaine. Groups did not differ with respect to patient satisfaction, incidence of bradycardia/hypotension, and transient neurologic symptom rate.ConclusionsFor spinal anesthesia in patients undergoing ambulatory knee arthroscopy, chloroprocaine has the shortest time to complete recovery of sensory and motor block compared with bupivacaine and lidocaine.
Exploring the associations between intraoperative electroencephalographic depression mediated by different anaesthetic drugs and negative postoperative behavioural changes in children undergoing day surgery: a protocol for a two-centre randomised clinical trial
Background Negative postoperative behavioural changes (NPOBCs) are among the most common complications of paediatric anaesthesia. The association between electroencephalogram (EEG) suppression and postoperative outcomes in previous clinical studies has been limited to delirium occurring early in the anaesthesia recovery room, and there are no reports of associations with negative postoperative behavioural changes in the distant postoperative period. However, this has important implications for children undergoing day surgery who are discharged on the same day after surgery. Methods The objective of this study is to investigate the mediating effects of intraoperative EEG patterns and negative postoperative behavioural changes in children undergoing paediatric day surgery. This study is a two-centre, prospective, randomised, single-blind, controlled trial involving 854 paediatric patients undergoing day surgery at the Children’s Hospital of Nanjing Medical University and Zhongda Hospital of Southeast University; these patients are randomly assigned into two groups: the propofol intravenous anaesthesia, which is induced and maintained with propofol, group (Group T) and the sevoflurane inhalation anaesthesia, which is induced and maintained with sevoflurane, group (Group S). The depth of anaesthesia is monitored for both groups of children, and the EEG characteristics of the children are extracted. The primary outcome measure is the incidence of negative behavioural changes during the first three days after surgery. The secondary outcomes include evaluating the incidence of negative behavioural changes at 1, 7, and 28 days postoperatively and investigating the relationship between intraoperative EEG patterns and NPOBCs. The study flow diagram is presented in Fig. 1. Discussion The aim of this clinical trial is to prospectively observe the mediating effects of intraoperative EEG forms and negative postoperative behavioural changes in children undergoing paediatric day surgery and to further explore the possible mechanisms of negative postoperative behavioural changes in paediatric anaesthesia. Moreover, in paediatric day surgery, the postoperative discharge assessment of children still lacks the ability to predict negative postoperative behavioural changes, and this study will construct a prediction model of negative postoperative behavioural changes to help anaesthesiologists more comprehensively assess whether children meet the criteria for discharge and to improve the quality of postoperative rehabilitation of children. Trial registration The study protocol was registered with the China Clinical Trial Registry ( http://www.chictr.org.cn ) on 1 July 2024 under the registration number ChiCTR2400086403. This trial is retrospectively registered.
The effectiveness of ambulatory continuous popliteal sciatic nerve blockade on patient-reported overall benefit of analgesia in patients undergoing foot or ankle surgery (CAREFREE trial); a randomized, open label, non-inferiority trial
Management of pain after foot and ankle surgery remains a concern for patients and healthcare professionals. This study determined the effectiveness of ambulatory continuous popliteal sciatic nerve blockade, compared to standard of care, on overall benefit of analgesia score (OBAS) in patients undergoing foot or ankle surgery. We hypothesized that usage of ambulatory continuous popliteal sciatic nerve blockade is non-inferior to standard of care. Single center, randomized, non-inferiority trial. Tertiary hospital in the Netherlands. Patients were enrolled if ≥18 years and scheduled for elective inpatient foot or ankle surgery. Patients were randomized to ambulatory continuous popliteal sciatic nerve blockade or standard of care. The primary outcome was the difference in OBAS, which includes pain, side effects of analgesics, and patient satisfaction, measured daily from the first to the third day after surgery. A non-inferiority margin of 2 was set as the upper limit for the 90% confidence interval of the difference in OBAS score. Mixed-effects modeling was employed to analyze differences in OBAS scores over time. Secondary outcome was the difference in opioid consumption. Patients were randomized to standard of care (n = 22), or ambulatory continuous popliteal sciatic nerve blockade (n = 22). Analyzing the first three postoperative days, the OBAS was significantly lower over time in the ambulatory continuous popliteal sciatic nerve blockade group compared to standard of care, demonstrating non-inferiority (−1.9 points, 90% CI -3.1 to −0.7). During the first five postoperative days, patients with ambulatory continuous popliteal sciatic nerve blockade consumed significantly fewer opioids over time compared to standard of care (−8.7 oral morphine milligram equivalents; 95% CI -16.1 to −1.4). Ambulatory continuous popliteal sciatic nerve blockade is non-inferior to standard of care with single shot popliteal sciatic nerve blockade on patient-reported overall benefit of analgesia. •Ambulatory nerve blocks are safe and feasible in foot and ankle surgery.•Ambulatory nerve blockade is non-inferior on overall benefit of analgesia.•Reduced opioid consumption makes this a promising option for foot or ankle surgery.