Instillation of Bupivacaine With Epinephrine Over Diaphragm to Reduce Postoperative Shoulder Pain Following Benign Gynecologic Laparoscopic Surgery: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post-operative shoulder pain scores
研究概览
简要总结
Postoperative shoulder pain is often reported to be particularly bothersome after laparoscopy. The benefits of local anesthetic, such as bupivacaine, applied to subcutaneous tissue for general postoperative pain management after surgery is well established. However, there have been no studies on sprayed bupivacaine over the diaphragm to reduce shoulder pain in laparoscopic surgery. The purpose of the study is to evaluate if sprayed infra-diaphragmatic bupivacaine compared to placebo (saline) will improve postoperative shoulder pain in patients undergoing benign laparoscopic gynecologic surgery. The entire study will be conducted at Cedar Sinai Medical Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants are randomized into either the treatment arm with placement of bupivacaine with epinephrine over the diaphragm or the no intervention arm. Participants are blinded to whether or not they received the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provide a signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •8 years of age or older
- •Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
排除标准
- •Pregnancy
- •Urgent/non-scheduled surgery
- •Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure)
- •Baseline shoulder pain
- •Baseline opioid use
- •Baseline of chronic pain syndrome
- •Conversion to open surgery
- •Allergy or intolerance to bupivacaine, lidocaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen
- •Planned post-operative admission
研究组 & 干预措施
Bupivacaine with epinephrine
Participants randomized to this arm will have 30 mL of 0.25% bupivacaine with epinephrine 1:200,000 (total of 75 mg) placed over the diaphragm laparoscopically at the conclusion of the laparoscopic gynecologic procedure.
干预措施: Instillation of Bupivacaine with epinephrine over the diaphragm (Drug)
No intervention
No additional intervention will be performed.
结局指标
主要结局
Post-operative shoulder pain scores
时间窗: 24 hours postoperatively
Reported right shoulder pain score using visual analog score (VAS) 24 hours postoperatively Null hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis = pain scores will be lower among the bupivacaine with epinephrine group Assessed using the validated 100-mm scale with a range of 0-10 (11-point numerical rating scale), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis
次要结局
- Post-operative generalized pain scores(up to 6 hours in post-anaesthesia care unit (PACU))
- Total analgesic requirements in post-anaesthesia care unit (PACU) in morphine equivalents(up to 6 hours in post-anaesthesia care unit (PACU))
- Length of stay in post-anaesthesia care unit (PACU)(up to 6 hours in post-anaesthesia care unit (PACU))
- Post-operative shoulder pain scores at home(5 days postoperatively)
- Post-operative opioid use(1 week postoperative)
- Surgical outcome: EBL(up to 8 hours)
- Surgical outcome: operative time(up to 8 hours)
- Surgical outcome: intraoperative complications(within 1 week of surgery)
- Surgical outcomes: conversion to laparotomy(within 6 hours of surgery start time)
研究者
Kelly Wright
Division Director of Minimally Invasive Gynecologic Surgery
Cedars-Sinai Medical Center