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1,514 result(s) for "ropivacaine"
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Evaluating the efficacy and safety of perianal injection of liposomal ropivacaine HR18034 for postoperative analgesia following hemorrhoidectomy: A multicenter, randomized, double-blind, controlled phase II clinical trial
HR18034, composed of the ropivacaine encapsulated in multi-lamellar, concentric circular structure liposomes as the major component and a small amount of free ropivacaine, has performed well in animal experiments and phase I clinical trials. This trial was to investigate the efficacy, safety, pharmacokinetic profile and the minimum effective dose of HR18034 for postoperative analgesia after hemorrhoidectomy compared with ropivacaine. A multicenter, randomized, double-blind trial. 19 medical centers in China. 85 patients undergoing hemorrhoidectomy between October 2022 to November 2022. Patients were randomly divided into HR 18034 190 mg group, 285 mg group, 380 mg group and ropivacaine 75 mg group, receiving single local anesthetic perianal injection for postoperative analgesia. The primary outcome was the area under the resting state NRS score -time curve within 72 h after injection. The second outcomes included the proportion of patients without pain, the proportion of patients not requiring rescue analgesia, cumulative morphine consumption for rescue analgesia, etc. Safety was evaluated by adverse events incidence and plasma ropivacaine concentrations were measured to explore the pharmacokinetic characteristics of HR18034. The areas under the NRS score (at rest and moving states)-time curve were significantly lower in HR 18034 380 mg group than ropivacaine 75 mg at 24 h, 48 h, and 72 h after administration. However, this superiority was not observed in HR18034 190 mg group and 285 mg group. There was no difference in cumulative morphine consumption for rescue analgesia between HR 18034 groups and ropivacaine group. HR 18034 380 mg showed superior analgesic efficacy and equivalent safety compared to ropivacaine 75 mg after hemorrhoidectomy, thus preliminarily determined as minimum effective dose. HR 18034 380 mg showed superior analgesic efficacy (lower area under the resting and moving states NRS score-time curve, The higher proportion of patients free of pain) and equivalent safety compared to ropivacaine 75 mg after hemorrhoidectomy, thus preliminarily determined as minimum effective dose. [Display omitted] •Few clinical studies have been conducted on liposomal ropivacaine. No randomized controlled trial of perianal injection, local infiltration anesthesia for post-hemorrhoidectomy analgesia has been reported.•Consisted of a small fraction of free ropivacaine and a predominant portion of ropivacaine encapsulated by multi-layered concentric circular liposome, HR 18034 has an innovative structure, providing rapid pain relief of operative incision through free ropivacaine and sustained analgesia via slow release of the encapsulated ropivacaine from the liposome.•In addition to evaluating the safety and efficacy of the drug, the pharmacokinetic characteristics of the HR 18034 were reported in this study to further guide the clinical applications.
Comparative Evaluation of the Efficacy and Safety Profiles of Various Ropivacaine Proportions in Cesarean Section
Ropivacaine (Ropi) is a widely utilized anesthetic in cesarean sections (CS), however its optimal dosage remains controversial. To assess the efficacy and safety of varying doses (10mg, 5mg, 4mg, and 3mg) of Ropi in subarachnoid block (SA) for CS. A prospective cohort study was conducted, and a total of 74 pregnant women undergoing CS at Nantong Maternal and Child Health Care Hospital between January and June 2023 were selected as the study population. Participants were stratified into groups based on Ropivacaine dosage: Group A (10 mg, n=18), Group B (5 mg, n=26), Group C (4 mg, n=15), and Group D (3 mg, n=15). The total Ropivacaine dosage administered via SA was consistently 10 mg across all groups. We measured anesthetic efficacy, safety profiles, abdominal wall muscle relaxation, pre- and post-anesthesia stress and inflammatory responses before and after anesthesia and compared among the four groups. Group A exhibited the shortest onset time for block initiation and longest recovery duration (P < .05). Group D displayed the highest incidence of patients requiring additional anesthetics and experiencing adverse reactions, whereas the utilization rate of vasopressors was most pronounced in Group A (P < .05). Notably, Group D reported the lowest satisfaction rate regarding abdominal wall muscle relaxation (P < .05). Stress responses were significantly lower in Groups A, B, and C compared to Group D, while the levels of inflammatory factors in Groups B and C were higher than those in Group A but lower than those in Group D (P < .05). Administration of 4 mg hyperbaric Ropi in SA can achieve an optimal anesthesia effect in CS with a high level of safety, along with inducing mild abdominal wall muscle relaxation and attenuating stress and inflammatory responses pre- and post-anesthesia. Thus, it is recommended for clinical application.
Evaluation of Ropivacaine and 3-OH-Ropivacaine Pharmacokinetics Following Interpectoral Nerve Block via LC-MS/MS—A Pilot Study
Regional anesthesia techniques such as the ultrasound-guided PECS II (pectoral nerve block) block are increasingly employed to optimize perioperative analgesia while minimizing systemic anesthetic exposure. Ropivacaine is commonly used for its favorable pharmacological profile; however, clinical data on its pharmacokinetics and systemic metabolite behavior following interpectoral administration remain limited. This study aimed to characterize the plasma concentration–time profile of ropivacaine and its main active metabolite, 3-OH-ropivacaine, in patients undergoing interpectoral nerve block, using a validated LC-MS/MS (liquid chromatography coupled with mass spectrometry) method. Venous blood samples were collected from 18 patients at predefined time points (0, 1, 3, 6, and 24 h) following a PECS II block performed with a ropivacaine-lidocaine mixture. Plasma concentrations were quantified via a validated LC-MS/MS protocol in accordance with FDA (Food and Drug Administration) and EMA (European Medicines Agency) guidelines. Pharmacokinetic parameters were derived using non-compartmental analysis. Ropivacaine reached a mean peak plasma concentration (Cmax—maximum concentration) of 167.5 ± 28.3 ng/mL at 1.3 ± 0.2 h (Tmax—maximum time). The metabolite 3-OH-ropivacaine peaked at 124.1 ± 21.4 ng/mL at 2.3 ± 0.3 h. The terminal elimination half-life was 19.4 ± 2.8 h for ropivacaine and 29.2 ± 3.1 h for its metabolite. Plasma levels demonstrated prolonged systemic exposure with predictable pharmacokinetics. The PECS II block using ropivacaine results in sustained systemic levels of both the parent drug and its primary metabolite, supporting its role in prolonged perioperative analgesia. These data provide a pharmacokinetic foundation for personalized regional anesthesia protocols. This strategy facilitates the adaptation of anesthetic protocols to the individual characteristics of each patient, aligning with the principles of personalized medicine, particularly in patients with altered metabolic capacity.
EASIER trial (Erector-spinAe analgeSia for hepatopancreaticobiliary pain In the Emergency Room): a single-centre open-label cohort-based randomised controlled trial analysing the efficacy of the ultrasound-guided erector-spinae plane block compared with intravenous morphine in the treatment of acute hepatopancreaticobiliary pain in the emergency department
BackgroundUltrasound-guided (USG) erector-spinae plane block (ESPB) may be better than intravenous opioids in treating acute hepatopancreaticobiliary (HPB) pain in the ED.MethodsThis open-label randomised controlled trial was conducted in the ED of a tertiary-care hospital between March and August 2023. All adult patients with severe HPB pain were recruited during times that a primary investigator was present. Unconsenting patients, numeric rating scale (NRS) ≤6, age ≤18 and ≥80 years, pregnant, unstable or with allergies to local anaesthetics or opioids were excluded. Patients in the intervention arm received bilateral USG ESPB with 0.2% ropivacaine at T7 level, by a trained ED consultant, and those in the control arm received 0.1 mg/kg intravenous morphine. Pain on a 10-point NRS was assessed by the investigators at presentation and at 1, 3, 5 and 10 hours after intervention by the treatment team, along with rescue analgesia requirements and patient satisfaction. Difference in NRS was analysed using analysis of co-variance (ANCOVA) and t-tests.Results70 participants were enrolled, 35 in each arm. Mean age was 40.4±13.2 years, mean NRS at presentation in the intervention arm was 8.0±0.9 and 7.6±0.6 in the control arm. NRS at 1 hour was significantly lower in the ESPB group (ANCOVA p<0.001). At 1, 3, 5 and 10 hours, reduction of NRS in the intervention arm (7±1.6, 6.7±1.9, 6.6±1.8, 6.1±1.9) was significantly greater than the control arm (4.4±2, 4.6±1.8, 3.7±2.2, 3.8±1.8) (t-test, p<0.001). Fewer patients receiving ESPB required rescue analgesia at 5 (t-test, p=0.031) and 10 hours (t-test, p=0.04). More patients were ‘very satisfied’ with ESPB compared with receiving only morphine at each time period (p<0.001).ConclusionESPB is a promising alternative to morphine in those with HPB pain.Trial registration numberCTRI/2023/03/050595.
Comparison of different adjuvant analgesia for paravertebral block in video-assisted thoracoscopic surgery: A double-blind randomized controlled trial
Local anaesthetic adjuvants have been shown to provide better pain relief and extend the duration of analgesia. But little information is available on which adjuvants are more effective in block extension for thoracic paravertebral block (TPVB) during video-assisted thoracoscopic surgery (VATS). This study aimed to compare the analgesic efficacies of different adjuvants with 0.375% ropivacaine in ultrasound-guided TPVB for VATS. A total of 120 patients who underwent VATS at the study hospital in 2022-2023 were recruited and randomly divided into four groups, including the control group (Group R), which received 20 ml ropivacaine 0.375% for TPVB, and the intervention groups: Group D (0.375% ropivacaine with 1 µg/kg dexmedetomidine in a total of 20 ml for TPVB), group E (0.375% ropivacaine with 0.1 mg/kg dexamethasone in a total of 20 ml for TPVB), and group S (0.375% ropivacaine with 0.5ug/ml sufentanil in a total of 20 ml for TPVB). They received a single-injection ultrasound-guided unilateral T5-level TPVB. The primary clinical outcomes were visual analogue scale (VAS) pain scores at rest and during coughing at 4, 8, 12, 16, 20, 24, and 48 h postoperatively. Secondary outcomes included opioid consumption, number of patient-controlled intravenous analgesics (PCIA) used within 48 h, postoperative rescue analgesia, side effects, quality of recovery after surgery, and length of hospital stay. We found that the VAS pain scores in the resting state during the postoperative period at 12-20 h were lower in Group D than in Group R (P < 0.05). The resting VAS pain scores of Groups E and S were lower than those of Group R during the postoperative period of 12-16 h (P < 0.05). Similar differences were observed in the pain scores during coughing at the same time points. Additionally, the co-administration of adjuvants with ropivacaine were associated with decreased consumption of postoperative opioids, less frequent PCIA use, and earlier time to ambulation. The intergroup pairwise comparisons showed that dexmedetomidine was more effective than dexamethasone and sufentanil in reducing additional postoperative analgesics, the length of chest tube placement and length of hospital stay. Subsequently, we administered questionnaires on the quality of recovery, which was positively correlated with the postoperative analgesic effect. These findings suggest that adjuvant analgesia for TPVB can improve postoperative pain in patients undergoing VATS. However, compared with dexamethasone and sufentanil, dexmedetomidine is more effective in extending the duration of analgesia, reducing the demand of postoperative analgesics, improving the quality of recovery at 48 h postoperatively and shorting the length of hospital stay.
Effect of Scalp Nerve Block with Ropivacaine on Postoperative Pain in Patients Undergoing Craniotomy: A Randomized, Double Blinded Study
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.
No quadriceps muscle weakness following anterior quadratus lumborum block compared with placebo: a randomized, non-inferiority, blinded, volunteer trial
Background and aimsAnterior quadratus lumborum block is a truncal block, applied in close proximity to the lumbar plexus, potentially causing lower limb weakness. This trial aimed to evaluate whether a unilateral anterior quadratus lumborum block caused quadriceps muscle weakness compared with placebo.MethodsIn this randomized, non-inferiority, triple-blind trial, 20 healthy volunteers received an active unilateral anterior quadratus lumborum block with 30 mL ropivacaine 0.75% and a placebo block on the contralateral side. Primary outcome was change in maximal quadriceps muscle strength from baseline to 60 min postblock compared with placebo. Secondary outcomes were change in single-leg 6 m timed hop test, change in Timed-Up and Go test, change in mean arterial pressure from baseline to 30 min postblock and dermatomal affection.ResultsThere was no statistically significant difference in changes in maximal quadriceps muscle strength between active and placebo block; 15.88 N (95% CI −12.19 to +43.94), pnon-inf=0.003, indicating non-inferiority. Timed-Up and Go test was performed significantly faster 60 min postblock; −0.23 s (95% CI −0.38 to −0.08, p=0.005). Mean change in mean arterial pressure from baseline to 30 min postblock was 4.25 mm Hg (95% CI 0.24 to 8.26, p=0.04). Dermatome testing revealed an affection primarily of the lower abdomen (Th10-L1) with the active block.ConclusionIn this randomized controlled trial including healthy volunteers a unilateral anterior quadratus lumborum block does not cause statistical or clinical significant motor block of the quadriceps muscle compared with placebo. When administered correctly, the block can be used for procedures where early postoperative mobilization is essential.Trial registration number NCT05023343.
The Safety and Efficacy of Ultrasound-Guided Bilateral Dual Transversus Abdominis Plane (BD-TAP) Block in ERAS Program of Laparoscopic Hepatectomy: A Prospective, Randomized, Controlled, Blinded, Clinical Study
Postoperative pain management for patients undergoing hepatic resection is still a challenge due to the risk of perioperative liver dysfunction. The transversus abdominis plane (TAP) block is a promising regional analgesic technique. However, the correct guidelines regarding the dose and regimen of local anesthetics in patients undergoing hepatic resection have yet to be established completely. This study aimed to evaluate the safety and efficacy of ultrasound-guided BD-TAP block with a large dose of ropivacaine in laparoscopic hepatectomy. This prospective, blinded, randomized, controlled study was conducted with 50 patients who were scheduled for selective laparoscopic hepatectomy. Patients who received a BD-TAP block (3 mg/kg of ropivacaine diluted to 60 mL) with general anesthesia were categorized into the BD-TAP block group (n = 25), and those who received general anesthesia were categorized into the control group (n = 25). The primary outcomes were consumption of sufentanil within 48 hours post-operation and plasma ropivacaine concentration. The secondary outcomes were the severity of pain (at rest and upon coughing), nausea and/or vomiting, and quality of recovery. Compared with the control group, the patients in BD-TAP block group had a significant reduction of postoperative sufentanil consumption at 2 hours ( = 0.019), 24 hours ( = 0.001), and 48 hours ( = 0.001), and the visual analog scale (VAS) scores on coughing were significantly lower at postoperative 2 hours ( = 0.004). There were no statistically significant differences in postoperative nausea and/or vomiting, flatus, catheter removal, off-bed activity, liver function, or postoperative hospital stay. The mean peak total ropivacaine concentration was 1,067.85 ng/mL, which occurred 1 hour after administering the block, and mean free ropivacaine concentration was 52.32 ng/mL. The highest individual peak plasma concentration was 2,360.90 ng/mL at 45 min postinjection, and the free ropivacaine concentration was 139.29 ng/mL. Ultrasound-guided BD-TAP block provides effective postoperative analgesia after laparoscopic hepatectomy. This study also confirms that ultrasound-guided BD-TAP blocks with 3 mg/kg ropivacaine during laparoscopic hepatectomy almost never results in the plasma ropivacaine concentrations associated with neurotoxicity.
Dexamethasone as an adjuvant with ropivacaine in thoracoscopy guided thoracic paravertebral block for postoperative analgesia in thoracic surgery
Ropivacaine for thoracoscopy-guided thoracic paravertebral block (TTPB) offers only a short duration of postoperative pain relief, which is inadequate for managing pain following thoracic surgery. Research has shown that combining dexamethasone with ropivacaine significantly prolongs the duration of analgesia from the nerve block. We hypothesised that TTPB with ropivacaine combined with dexamethasone would enhance postoperative analgesia and prolong the duration of analgesia in patients undergoing radical thoracoscopic lung cancer surgery. The study randomly assigned patients to either a control group (Group C, n = 40) or a dexamethasone group (Group D, n = 40). TTPB injection of ropivacaine or ropivacaine combined with dexamethasone prior to surgical sutures. The study compared postoperative pain satisfaction scores、48 h postoperative rescue analgesia frequency、visual analogue scale (VAS) scores, the 24-h patient-controlled analgesia (PCIA) sufentanil consumption, blood glucose levels, adverse events and recovery status. Group D demonstrated higher postoperative pain satisfaction scores and lower 48 h postoperative rescue analgesia frequency compared to Group C. Additionally, Group D had significantly lower VAS scores at 6, 12, 24, and 48 h post-operation, as well as a reduced 24-h PCIA sufentanil consumption, shorter time to first mobilization, and shorter hospital stay compared to Group C (all P  < 0.05). The VAS scores at 2 h postoperatively were significantly lower in Group D compared to scores at 24 and 48 h postoperatively. Conversely, Group C showed significantly lower VAS scores at 2 h postoperatively compared to scores at 6, 12, 24, and 48 h postoperatively. The addition of dexamethasone as an adjuvant to ropivacaine enhanced the analgesic efficacy of TTPB, prolonged the duration of pain relief, and reduced the time to first ambulation and hospital stay duration. Trial Registry : ChiCTR (2400086347); Registered 28/06/2024.
Efficacy of compound betamethasone combined with ropivacaine in iliac fascial space nerve block analgesia
To explore the anesthetic efficacy of ropivacaine combined with compound betamethasone in iliac fascial space nerve block analgesia (IFNBA) in patients receiving artificial femoral head replacement (AFHR), and to provide a theoretical basis for the selection of clinical anesthetic drugs. From January 2022 to June 2022, 70 patients requiring IFNBA analgesia undergoing AFHR surgery at our hospital were included in this prospective study. Using Excel randomization, 70 patients were divided into study group ( n  = 35) and control group ( n  = 35). The study group received ropivacaine combined with compound betamethasone analgesia regimen, while the control group only received ropivacaine analgesia regimen. In addition to patients’ general baseline clinical characteristics, outcomes indicators included preoperative and postoperative visual analogue scale (VAS) pain scores, preoperative and postoperative Ramsay sedation scores, preoperative and postoperative levels of inflammatory cytokines, duration of analgesia and patient satisfaction in both groups were collected. At 12 h and 24 h after surgery, the static and dynamic VAS pain score of the study group was significantly lower than that of the control group ( P  < 0.05). At 6 h and 12 h after surgery, the Ramsay sedation score of the study group was significantly higher than that of the control group ( P  < 0.05). The level of inflammatory cytokines in the study group was significantly lower than that in the control group at the completion of surgery, 24 h and 72 h after surgery ( P  < 0.05). In addition, the study group had a significantly longer duration of postoperative analgesia and significantly better patient satisfaction ( P  < 0.05). Especially for patients receiving AFHR, in IFNBA, ropivacaine combined with compound betamethasone has better analgesic effect, higher patient satisfaction, and can effectively reduce the level of inflammatory status, which is worthy of clinical application and promotion.