Impact of Preoperative Quadratus Lumborum Block on Postoperative Opioid Consumption After Laparoscopic Hysterectomy: a Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Intraoperative opioid use
研究概览
简要总结
The goal of this clinical trial is to learn if preoperative nerve block (quadratus lumborum [QL] block) works to improve pain control during and after laparoscopic hysterectomy. The main questions it aims to answer are:
Does QL block decrease the amount of narcotic medication needed during surgery? Does QL block decrease the amount of narcotic medication needed after surgery?
Researchers will compare QL block to local injection of a numbing medication at each incision site (the current standard practice) to see if QL block works to decrease surgical pain.
Participants will be randomly assigned to receive one of the two following interventions:
- QL block before surgery with a long-acting numbing medicine (liposomal bupivacaine) and then injection of placebo (saline) at each incision site in the operating room.
- QL block before surgery with placebo (saline) and then injection of local numbing medicine (bupivacaine) at each incision site in the operating room.
Participants will also:
- Visit the clinic/hospital for a pre-operative appointment, the surgical procedure, and a 4-6 week post-operative appointment (all standard visits even if not participating in research)
- Complete a questionnaire electronically, or by phone, that takes <10 minutes at the pre-operative appointment and on postoperative days 1, 3, 5, 14, and 4-6 weeks.
详细描述
Context: (Background) Given the opioid epidemic, gynecologic enhanced recovery after surgery (ERAS) pathways have been developed to reduce post-operative narcotic use through multimodal pain regimens and pre-surgical anesthetic adjuncts. While local anesthetic injection at trocar incision sites has long been accepted as a standard practice to decrease postoperative pain in laparoscopic surgery, including hysterectomy, regional nerve blockades are emerging as a promising adjunct technique for management of perioperative pain. At this time, the data evaluating the effect of regional nerve blocks on postoperative pain after laparoscopic hysterectomy are limited, thus the investigators designed the following study.
Objectives: (primary and secondary objectives) To determine the impact of preoperative quadratus lumborum (QL) block on postoperative pain following laparoscopic hysterectomy. The primary outcomes will be intraoperative and immediate post-operative opioid use, measured in morphine equivalent dose (MED). Secondary outcomes will include pain scores, functional impact of pain, perception of pain and recovery, voiding dysfunction, time to discharge, nausea/vomiting, emergency room visits, readmission, and reoperation rates.
Study Design:
This study is designed as a prospective, double-blinded, randomized controlled trial comparing opioid use in women undergoing laparoscopic hysterectomy who receive a preoperative QL block to local injection of bupivacaine (common local anesthestic).
Setting/Participants:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinded parties = subject, surgical team, intraoperative anesthesia team, postoperative anesthesia team, study investigators Unblinded parties = preoperative anesthesia team (providers that perform the quadratus lumborum block)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •scheduled to undergo laparoscopic hysterectomy
- •able to speak and understand English
- •DEERs eligible (eligible for healthcare within military heath system)
- •Owning a phone that can receive text messages or having internet access to complete questionnaires
排除标准
- •pre-operative opioid use
- •pre-operative pain management clinic patient
- •planned concomitant prolapse or incontinence procedure
- •planned concomitant non-gynecologic abdominal procedure (i.e. hernia repair)
- •inability to receive liposomal or non-liposomal bupivacaine
- •inability to receive non-steroidal anti-inflammatory drugs (NSAIDs)
- •inability to receive acetaminophen
- •inability to receive oxycodone
- •QL block not able to be performed bilaterally
- •planned or performed mini-laparotomy (incision greater than 2cm)
- •case converted to laparotomy
研究组 & 干预措施
Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placebo
Subjects will receive a pre-operative quadratus lumborum nerve block with liposomal bupivacaine and then an intra-operative placebo injection at each incision site with saline.
干预措施: Quadratus Lumborum Block (QLB) (Drug)
Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placebo
Subjects will receive a pre-operative quadratus lumborum nerve block with liposomal bupivacaine and then an intra-operative placebo injection at each incision site with saline.
干预措施: Local Anesthetic Solution (Drug)
Preoperative QL block with placebo, intra-operative incisional injection with bupivacaine
Subjects will undergo a sham pre-operative quadratus lumborum block procedure with saline and then an intra-operative injection of local anesthetic (0.25% bupivacaine) at each incision site.
干预措施: Quadratus lumborum block (Drug)
Preoperative QL block with placebo, intra-operative incisional injection with bupivacaine
Subjects will undergo a sham pre-operative quadratus lumborum block procedure with saline and then an intra-operative injection of local anesthetic (0.25% bupivacaine) at each incision site.
干预措施: Local Anesthetic Solution (Drug)
结局指标
主要结局
Intraoperative opioid use
时间窗: From anesthesia induction to the time the patient leaves the operating room, this is considered the "in-room time". Anticipated to be between 2-6 hours. Will be assessed up to 12 hours.
Total opioid dose, calculated in morphine equivalent dose, required during intraoperative anesthesia care
Immediate post-operative opioid use
时间窗: From time of arrival in the PACU to time of discharge from the hospital. Anticipated to be the same day, about 4-6 hours post-operative. Will be assessed up to 24 hours after surgery if the patient remains admitted.
Total opioid dose, calculated in morphine equivalent dose, required after surgery prior to discharge from the hospital
次要结局
- Opioid use after discharge(From discharge from the hospital to the 4-6 week post-operative appointment.)
- Pain scores during inpatient post-operative care(From time of arrival in the PACU to time of discharge from the hospital. Anticipated to be the same day, about 4-6 hours post-operative. Will be assessed up to 24 hours after surgery if the patient remains admitted.)
- Time to PACU discharge(From time of arrival in the PACU to time of transfer to the second phase of post-operative care. Anticipated to be about 1-3 hours post-operative. Will be assessed up to 12 hours after surgery if the patient remains in the PACU.)
- Voiding dysfunction(From time of arrival in the PACU to time of discharge from the hospital. Anticipated to be the same day, about 4-6 hours post-operative. Will be assessed up to 24 hours after surgery if the patient remains admitted.)
- Pain scores after discharge(From discharge from the hospital to the 4-6 week post-operative appointment.)
- Quality of Recovery-15 scores after discharge(From discharge from the hospital to the 4-6 week post-operative appointment.)