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Background It is debatable whether opioid-free anaesthesia (OFA) is better suited than multimodal analgesia (MMA) to achieve the goals of enhanced recovery after surgery (ERAS) in patients undergoing laparoscopic sleeve gastrectomy. Methods In all patients, anaesthesia was conducted with an i.v. induction with propofol (2 mg. kg-1), myorelaxation with cisatracurium (0.15 mg.kg-1), in addition to an ultrasound-guided bilateral oblique subcostal transverse abdominis plane block. In addition, patients in the OFA group ( n  = 51) received i.v. dexmedetomidine 0.1 μg.kg-1 and ketamine (0.5 mg. kg-1) at induction, then dexmedetomidine 0.5 μg. kg-1.h-1, ketamine 0.5 mg.kg-1.h-1, and lidocaine 1 mg. kg-1.h-1 for maintenance, while patients in the MMA group ( n  = 52) had only i.v. fentanyl (1 μg. kg-1) at induction. The primary outcome was the quality of recovery assessed by QoR-40, at the 6th and the 24th postoperative hour. Secondary outcomes were postoperative opioid consumption, time to ambulate, time to tolerate oral fluid, and time to readiness for discharge. Results At the 6th hour, the QoR-40 was higher in the OFA than in the MMA group (respective median [IQR] values: 180 [173–195] vs. 185 [173–191], p  < 0.0001), but no longer difference was found at the 24th hour (median values = 191 in both groups). OFA also significantly reduced postoperative pain and morphine consumption (20 mg [1–21] vs. 10 mg [1–11], p  = 0.005), as well as time to oral fluid tolerance (238 [151–346] vs. 175 min [98–275], p  = 0.022), and readiness for discharge (505 [439–626] vs. 444 min [356–529], p  = 0.001), but did not influence time to ambulate. Conclusion While regional anaesthesia achieved most of the intraoperative analgesia, avoiding intraoperative opioids with the help of this OFA protocol was able to improve several sensible parameters of postoperative functional recovery, thus improving our knowledge on the OFA effects. Clinical trial number Registration number NCT04285255.

Prostate cancer diagnosis requires biopsy, traditionally performed under local anaesthetic with ultrasound guidance via a transrectal approach (TRUS). Local anaesthetic ultrasound-guided transperineal biopsy (LATP) is gaining popularity in this setting; however, there is uncertainty regarding prostate sampling, infection rates, tolerability, side-effects, and cost-effectiveness. TRANSLATE was a randomised clinical trial that aimed to compare detection of Gleason Grade Group (GGG) 2 or higher prostate cancer, side-effects, tolerability, and patient-reported outcomes, after LATP versus TRUS biopsy. In this randomised clinical trial which was done at ten hospitals in the UK, patients aged 18 years or older were eligible if investigated for suspected prostate cancer based on elevated age-specific prostate-specific antigen or abnormal digital rectal examination, and if biopsy-naive having received pre-biopsy MRI on a 1·5 or higher Tesla scanner. Individuals were excluded if they had any previous prostate biopsy, extensive local disease easily detectable by any biopsy (prostate-specific antigen >50 ng/mL or entire gland replaced by tumour on MRI), symptoms of concurrent or recent urinary tract infection, history of immunocompromise, need for enhanced antibiotic prophylaxis, absent rectum, or inability to position in lithotomy. Participants were randomly assigned in a 1:1 ratio to receive LATP or TRUS biopsy, using web-based software with a randomisation sequence using a minimisation algorithm to ensure balanced allocation across biopsy groups for minimisation factors (recruitment site, and location of the MRI lesion). The primary outcome was detection of GGG 2 or higher prostate cancer, analysed in the modified intention-to-treat population (all randomly assigned to treatment who had a biopsy result available). Key secondary endpoints assessing post-biopsy adverse events were infection, bleeding, urinary and sexual function, tolerability, and patient-reported outcomes. This trial is registered with ClinicalTrials.gov (NCT05179694) and at ISRCTN (ISRCTN98159689), and is complete. Between Dec 3, 2021, and Sept 26, 2023, 2078 (76%) of 2727 assessed individuals were eligible, and 1126 (41%) of 2727 agreed to participate. 1044 (93%) of the 1126 participants were White British. Participants were allocated to TRUS (n=564) or LATP (n=562) biopsy, and were followed up at time of biopsy, and at 7 days, 35 days, and 4 months post-biopsy. We found GGG 2 or higher prostate cancer in 329 (60%) of 547 participants with biopsy results randomly assigned to LATP compared with 294 (54%) of 540 participants with biopsy results randomly assigned to TRUS biopsy (odds ratio [OR] 1·32 [95% CI 1·03–1·70]; p=0·031). Infection requiring admission to hospital within 35 days post-biopsy occurred in 2 (<1%) of 562 participants in the LATP group compared with 9 (2%) of 564 in the TRUS group. No statistically significant difference was observed in the reporting of overall biopsy-related complications (LATP 454 [81%] of 562 vs TRUS 436 [77%] of 564, OR 1·23 [95% CI 0·93 to 1·65]), urinary retention requiring catheterisation (LATP 35 [6%] of 562 vs TRUS 27 [5%] of 564), urinary symptoms (median International Prostate Symptom Score: LATP 8 [IQR 4–14] vs TRUS 8 [4–13], OR 0·36 [95% CI –0·38 to 1·10]), nor sexual function (median International Index of Erectile Function score: LATP 5 [2–25] vs TRUS 8 [3–24], OR –0·60 [–1·79 to 0·58]) at 4 months after biopsy. Trial participants more commonly reported LATP biopsy to be immediately painful and embarrassing compared with TRUS (LATP 216 [38%] of 562 vs TRUS 153 [27%] of 564; OR 1·84 [95% CI 1·40 to 2·43]). Serious adverse events occurred in 14 (2%) of 562 participants in the LATP group and 25 (4%) of 564 in the TRUS group. Among biopsy-naive individuals being investigated for possible prostate cancer, biopsy with LATP led to greater detection of GGG 2 or higher disease compared with TRUS. These findings will help to inform patients, clinicians, clinical guidelines, and policy makers regarding the important trade-offs between LATP and TRUS prostate biopsy. National Institute for Health and Care Research (NIHR) Health Technology Assessment.

No consensus has yet been reached regarding the best anesthetic technique for inguinal hernia repair. This study aimed to compare postoperative clinical outcomes and inflammatory markers among patients who were anesthetized using local, spinal, or general anesthesia for inguinal hernia repair. This randomized controlled trial included patients scheduled to undergo elective unilateral inguinal hernioplasty at Siriraj Hospital during November 2014 to September 2015 study period. Patients were randomly assigned to the local (LA), spinal (SA), or general (GA) anesthesia groups. Primary outcomes were postoperative pain at rest and on mobilization at 8 and 24 hours after surgery. Fifty-four patients were included, with 18 patients randomly assigned to each group. Patient demographic and clinical characteristics were similar among groups. There were no significant differences among groups for postoperative pain at rest or on mobilization at 8 and 24 hours after surgery. No significant differences were observed for interleukin-1β, interleukin-6, and interleukin-10 at any time points in any groups. Patients with local anesthesia was associated with less time spent in anesthesia (p = 0.010) and surgery (p = 0.009), lower intraoperative cost (p = 0.003) and total cost in hospital (p = 0.036); however, patient satisfaction in the local anesthesia group (94/100) was statistically significantly lower than the spinal and general anesthesia groups (100/100) (p = 0.010). No statistically significant difference was observed among groups for postoperative pain scores, duration of hospital stays, complications, or change in inflammatory markers. However, time spent in anesthesia and surgery, the intraoperative cost and total cost for hernia repair, and patient satisfaction were significantly lower in the local anesthesia group than in the other two groups.

Peripheral venous cannulation is one of the most common procedures in medicine. It is associated with noticeable pain and apprehension, although in most cases it is performed without any anesthesia due to lack of a painless, cost-effective option, which would provide rapid local anesthesia with subsequent significant reduction in the experienced pain. We conducted an open-label placebo-controlled clinical trial to evaluate the efficacy and safety of a 2% lidocaine injection using the commercially available microneedle device MinronJet600 (NanoPass Technologies Ltd, Israel) to achieve rapid local anesthesia prior to peripheral venous cannulation. One hundred and two subjects were randomly allocated into two groups. In the first group, 100μL of lidocaine hydrochloride (2%) was injected intradermally to subjects using the MicronJet600 device in the left arm (MJ-Lido) and 100μL of saline was injected intradermally using the device in the right arm (MJ-Saline). In the second group, 100μL of lidocaine hydrochloride (2%) was injected using the MicronJet600 device into the left arm (MJ-Lido), with no injection into the right arm of subjects (No pretreatment). In both groups the intradermal injection was performed at the cannulation site prior to insertion of a 18G cannula into a median cubital vein in both arms. As a primary variable, a score of cannulation-induced pain was indicated by subjects using a 100-point visual analog scale immediately after cannulation. As a secondary variable, subjects in Group 2 also indicated their preference to receive the anaesthetic injection with MicronJet600 in the future by using the 5-point Likert scale. Also, as a secondary variable, the duration of skin numbness after lidocaine injection was indicated by performing a superficial pin-prick with a 27G needle at 15, 30 and 45 minutes, at distances of 1, 2 and 3 centimeters from the injection site. A significant pain reduction (11.0-fold) was achieved due to the lidocaine injection compared to the cannulation without any pretreatment (p< 0.005). After the lidocaine injection the anesthesia was effective up to 2 centimeters from the injection site and remained for up to 30 minutes. Eighty percent of subjects from the second group preferred cannulation after the lidocaine injection over cannulation without any pretreatment. No significant side effects were identified. Intradermal injection of anaesthetic with Micronjet600 was found to be a safe and effective option for providing rapid local anesthesia for peripheral intravenous cannulation. The clinical trial was registered, before the patient enrollment began, in the Research Registry publicly accessible database (registration identifier: researchregistry4662). Also, the trial was registered in ClinicalTrials.gov (registration identifier: NCT05108714) after its completion.

Background Buzzy ® - a vibratory unit with ice wings -was introduced to reduce pain induced by needle prick. Objective of the study was to evaluate the effectiveness of “Buzzy ® ” in reducing pain perception during administration of maxillary infiltration local anaesthesia compared to the traditional topical anaesthetic gel in pediatric patients. In addition, it aimed to evaluate its effectiveness in intrapapillary anaesthesia in comparison to the conventional palatal injection following buccal infiltration anaesthesia. Methods Randomized controlled clinical trial with parallel arms. Forty-eight cooperative children aged 6–8 years indicated for maxillary first or second primary molar extractions were selected. They were randomly allocated into 2 main groups (I and II) then into 2 subgroups each (A and B). All groups received buccal infiltration anaesthesia. Group I received local anaesthesia following the use of Buzzy ® extra orally for 2 min. Group II received local anaesthesia following topical anaesthetic gel (benzocaine 20%) intraorally for 1 min. Subgroups A received routine palatal injection whereas subgroups B received intrapapillary anaesthesia. Each patient was videotaped during local anaesthesia injection to objectively assess the reaction using sound, eye, motor scale (SEM). After local anaesthesia administration, pain was subjectively assessed using the visual analogue scale (VAS). Normality was checked in age and VAS using Shaprio Wilk test. The Independent T test was used to compare age between groups. Differences in SEM and VAS between buzzy and infiltration groups were analyzed using the Mann Whitney U test while Wilcoxon sign Rank test was used to analyze the difference in SEM and VAS between intrapapillary and palatal injection within each group. All tests were two tailed and the significance level was set at p  value ≤ 0.05. Results No statistical significance was observed in pain perception between Buzzy and topical gel regarding buccal local anesthesia. Conversely, objective and subjective statistical significance in pain perception between (Group I) and (Group II) regarding both palatal and intrapapillary anesthesia was recorded. Conclusion Applying external cold and vibratory stimulant can reduce pain perception during maxillary buccal, intrapapillary and palatal local infiltration anesthesia. Clinical trial registration The clinical registration number in ClinicalTrials.gov holds the identifier: NCT05857033 retrospectively registered on 12/5/2023.

Background One of the main goals for pediatric dentists is to offer a painless anesthesia experience. Laser photobiomodulation is among the suggested strategies to decrease injection pain. So, this study aimed to assess the impact of laser photobiomodulation on local anesthesia (LA) injection pain in children and its effect on the efficacy of LA during pulpotomy and SSC procedures. Methods The research was carried out as a randomized controlled clinical trial with two parallel group design. It involved 64 cooperative healthy children, age range from 5 to 7 years, each having at least one maxillary molar indicated for pulpotomy. Children were randomly allocated to one of the two groups based on the pre-anesthetic tissue management technique used: test group received laser photobiomodulation, while control group received topical anesthetic gel. Pain during injection, pulpotomy, and SSC procedures was assessed using physiological measures (Heart Rate (HR)), subjective evaluation (modified Face-Pain‐Scale (FPS), and objective analysis (Sound‐Eye‐Motor scale (SEM)). Results A total of 64 children with mean age 6.23 ± 0.78 participated in this research. The mean HR scores were significantly lower in the laser PBM group during buccal and palatal infiltration injections. The SEM mean scores were significantly lower in the laser PBM group during both injections. For the FPS scale, the number of children who recorded satisfaction during injection was significantly higher in laser PBM group. There was no statistically significant difference in mean HR as well as in SEM and FPS scores between the two groups during pulpotomy and SSC procedures. Comparisons between the two study groups were performed using independent samples t- and Mann-Whitney U tests. Significance was set at p value < 0.05. Conclusion Laser photobiomodulation is a promising non-pharmacological pre-anesthetic tissue management technique in children that offered less painful injection compared to topical anesthetic gel without compromising the effectiveness of LA. Trial Registration ClinicalTrials.gov Identifier: NCT05861154. Registered on 16/5/2023. Graphical Abstract

Background and objectivesFascia iliaca compartment block (FICB) has been shown to provide excellent pain relief in patients undergoing total hip arthroplasty (THA). However, the analgesic efficacy of FICB, in comparison with periarticular infiltration (PAI) for THA, has not been evaluated. This randomized, controlled, observer-blinded study was designed to compare suprainguinal FICB (SFICB) with PAI in patients undergoing THA via posterior approach.MethodsAfter institutional review board approval, 60 consenting patients scheduled for elective THA were randomized to one of two groups: ultrasound-guided SFICB block or PAI. The local anesthetic solution for both the groups included 60 mL ropivacaine 300 mg and epinephrine 150 µg. The remaining aspects of perioperative care, including general anesthetic and non-opioid multimodal analgesic techniques, were standardized. An investigator blinded to group allocation documented pain scores at rest and with movement and supplemental opioid requirements at various time points. Patients were evaluated for sensory changes and quadriceps weakness in the operated extremity.ResultsThere were no differences between the groups with respect to demographics, intraoperative opioid use, duration of surgery, recovery room stay, nausea scores, need for rescue antiemetics, time to ambulation and time to discharge readiness as well as 48 hours postoperative opioid requirements. The pain scores at rest and with movement also were similar at all time points. Significantly more patients in the SFICB group experienced muscle weakness at 6 hours after surgery.ConclusionsUnder the circumstances of our study, in patients undergoing THA, SFICB provided the similar pain relief compared with PAI, but was associated with muscle weakness at 6 hours postoperatively.Trial registration number NCT02658240.

Background Despite the crucial role that randomised controlled trials (RCTs) play in establishing the efficacy of new treatments, many are terminated early due to difficulty with subject recruitment. Trials of complex perioperative interventions are notoriously difficult to deliver. We describe our experiences of successful recruitment into an RCT of anaesthetic technique in vascular access surgery with the aim of exploring barriers and enablers to efficient recruitment and trial delivery. Methods A mixed-methods approach was adopted to evaluate the recruitment and implementation processes of The Anaesthesia Choice for Creation of artEriovenouS fiStulae (ACCess) study ( https://doi.org/10.1136/bmjopen-2021-052188 ) (Deloitte. Patient Recruitment is Often the Holy Grail for Clinical Research…Could Virtual Trials Improve our Chances of Reaching It? 2020). Recruitment figures demonstrating trial progression and site set-up are reported quantitatively. Contemporaneous data was collected on site-specific challenges, particularly in relation to the COVID-19 pandemic. The Scottish Vascular Access Appraisal Service Evaluation Tool was utilised to summarise the pre-existing vascular access infrastructure at each site and inferences made about service “resilience”. An embedded process evaluation study, supplemented by the researchers own reflections, qualitatively explored motivators and challenges in trial set-up, recruitment and delivery utilising thematic analysis of semi-structured interviews with patients and health care practitioners (HCPs). A rapid feedback evaluation approach permitted within trial feedback to the main trial team. Results Five hundred seventy-one patients with stage V CKD or on haemodialysis were successfully recruited from 20 UK-centres over a 2-year period, making this the largest RCT of vascular access in Europe to date. A “desire to improve care for patients with kidney disease” was the main motivator for participation amongst both patients and HCPs. Good communication, strong leadership, and simple trial documentation were viewed as important enablers; whilst staffing shortages and reduced access to theatre were considered the principal barriers. Sites that reported well-established MDT-working appeared best-able to mitigate against these difficulties. A pragmatic trial protocol, which could easily be implemented within existing clinical practice, was considered essential for many centres. Anxiety and uncertainty associated with dialysis initiation was evident in reasons for non-participation with 32% declining participation due to an unwillingness for randomisation. Furthermore, the workload associated with travel to study visits and completion of “tiresome” HR-QOL questionnaires were considered additional barriers in a patient group with significant pre-existing treatment burden. Conclusions Despite anticipated challenges, target recruitment was achieved on schedule with predicted timelines. In depth knowledge of the patient population; early engagement of a broad multidisciplinary team; and a pragmatic protocol that could be effectively incorporated into routine clinical care proved fundamental to success. Consideration of these factors may be of benefit to other researchers designing clinical trials, especially within the renal population. Trial registration Both the ACCess study and process evaluation study are registered with the respective clinical trials databases: ISRCTN14153938 and MRC SWAT Repository 150.

Scalp nerve block with ropivacaine has been shown to provide perioperative analgesia. However, the best concentration of ropivacaine is still unknown for optimal analgesic effects. We performed a prospective study to evaluate the effects of scalp nerve block with varied concentration of ropivacaine on postoperative pain and intraoperative hemodynamic variables in patients undergoing craniotomy under general anesthesia. Eighty-five patients were randomly assigned to receive scalp block with either 0.2% ropivacaine, 0.33% ropivacaine, 0.5% ropivacaine, or normal saline. Intraoperative hemodynamics and post-operative pain scores at 2, 4, 6, 24 hours postoperatively were recorded. We found that scalp blockage with 0.2% and 0.33% ropivacaine provided adequate postoperative pain relief up to 2 h, while administration of 0.5% ropivacaine had a longer duration of action (up to 4 hour after craniotomy). Scalp nerve block with varied concentration of ropivacaine blunted the increase of mean arterial pressure in response to noxious stimuli during incision, drilling, and sawing skull bone. 0.2% and 0.5% ropivacaine decreased heart rate response to incision and drilling. We concluded that scalp block using 0.5% ropivacaine obtain preferable postoperative analgesia compared to lower concentrations. And scalp block with ropivacaine also reduced hemodynamic fluctuations in craniotomy operations.

Background Endemic goiter is highly prevalent in Uganda, placing a considerable surgical burden on the healthcare system. Across Africa, prevalence varies widely, reaching 60.2%, with visible goiter affecting 30% of Uganda’s rural population despite salt iodization programs. Despite evidence supporting thyroidectomy under local anesthesia (LA) for selected cases, its importance is underestimated moreover with limited access to general anesthesia (GA) and critical care providers in resource-constrained settings. The trial compared outcomes of thyroidectomy under LA versus GA in grade 1–2 uncomplicated euthyroid goiter patients in Uganda, with an aim to assess feasibility of LA as an alternative technique. Methods In this prospective equivalence randomized, single-blind controlled trial, participants with grade 1–2 uncomplicated euthyroid goiters were enrolled and randomly assigned to two arms (LA and GA) during surgical camps in Uganda. The study compared early postoperative outcomes, including nausea, vomiting, hematoma formation, transient voice changes, and pain at 6, 12, and 24 h. It also assessed overall incurred material and medication costs, patient satisfaction using a 5-point Likert scale, and willingness to undergo a similar procedure with the same anesthetic technique at 30 days. Results Fifty-eight participants undergoing thyroidectomy received random assignment, twenty-nine for each arm. No significant differences were found between the 2 groups in demographics, symptom duration, and early post-operative complications or patients’ level of satisfaction ( P  > 0.05). However, the overall material and medication costs were significantly lower in the LA Group ( P  < 0.001). Conclusions Thyroidectomy under LA can be performed in a well-selected patient population with low complication rates and comparable patient satisfaction to GA. These findings may support LA for thyroidectomy as a valuable cost-efficient alternative, especially in low-resource settings with fewer GA providers. Trial registration First registered on 31/07/2022, PACTR202208635457430 by Pan African Clinical Trial Registry.