Standard vs. Lower Pressure Pneumoperitoneum in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10)
研究概览
简要总结
This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon.
详细描述
This will be a single-center, single-blinded randomized controlled trial evaluating the impact of lower pressure pneumoperitoneum on post-operative pain and surgical field visualization among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that lower insufflation pressures will decrease post-operative pain in the immediate post-operative period without compromising surgical field visualization. The study will include 3 groups corresponding to varying insufflation pressures: 15mmHg (standard), 12mmHg and 10mmHg. Participants will be 1:1:1 allocated to the 15mmHg, 12mmHg or 10mmHg groups (parallel design) by block randomization.
Given inherent differences in how pneumoperitoneum is maintained during conventional versus robotic-assisted laparoscopic surgery, the investigators will be enrolling patients in two separate arms depending on their planned procedure:
- Standard vs. Lower Pressure Pneumoperitoneum in Conventional Laparoscopic Gynecologic Surgery
- Standard vs. Lower Pressure Pneumoperitoneum in Robotic-Assisted Laparoscopic Gynecologic Surgery.
The methodology for the two arms will be otherwise identical.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and post-anesthesia care unit nurses will be masked.
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •18 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 opioid use
- •Allergy or intolerance to bupivacaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen
- •Planned post-operative admission
研究组 & 干预措施
15mmHg (Conventional Laparoscopic Arm)
Standard Pressure, Conventional Laparoscopic Arm
干预措施: Carbon dioxide (Other)
15mmHg (Conventional Laparoscopic Arm)
Standard Pressure, Conventional Laparoscopic Arm
干预措施: Bupivacaine (Drug)
15mmHg (Conventional Laparoscopic Arm)
Standard Pressure, Conventional Laparoscopic Arm
干预措施: Oxycodone (Drug)
12mmHg (Conventional Laparoscopic Arm)
Lower Pressure, Conventional Laparoscopic Arm
干预措施: Carbon dioxide (Other)
12mmHg (Conventional Laparoscopic Arm)
Lower Pressure, Conventional Laparoscopic Arm
干预措施: Bupivacaine (Drug)
12mmHg (Conventional Laparoscopic Arm)
Lower Pressure, Conventional Laparoscopic Arm
干预措施: Oxycodone (Drug)
10mmHg (Conventional Laparoscopic Arm)
Lowest Pressure, Conventional Laparoscopic Arm
干预措施: Carbon dioxide (Other)
10mmHg (Conventional Laparoscopic Arm)
Lowest Pressure, Conventional Laparoscopic Arm
干预措施: Bupivacaine (Drug)
10mmHg (Conventional Laparoscopic Arm)
Lowest Pressure, Conventional Laparoscopic Arm
干预措施: Oxycodone (Drug)
15mmHg (Robotic-Assisted Laparoscopic Arm)
Standard Pressure, Robotic-Assisted Laparoscopic Arm
干预措施: Carbon dioxide (Other)
15mmHg (Robotic-Assisted Laparoscopic Arm)
Standard Pressure, Robotic-Assisted Laparoscopic Arm
干预措施: Bupivacaine (Drug)
15mmHg (Robotic-Assisted Laparoscopic Arm)
Standard Pressure, Robotic-Assisted Laparoscopic Arm
干预措施: Oxycodone (Drug)
12mmHg (Robotic-Assisted Laparoscopic Arm)
Lower Pressure, Robotic-Assisted Laparoscopic Arm
干预措施: Carbon dioxide (Other)
12mmHg (Robotic-Assisted Laparoscopic Arm)
Lower Pressure, Robotic-Assisted Laparoscopic Arm
干预措施: Bupivacaine (Drug)
12mmHg (Robotic-Assisted Laparoscopic Arm)
Lower Pressure, Robotic-Assisted Laparoscopic Arm
干预措施: Oxycodone (Drug)
10mmHg (Robotic-Assisted Laparoscopic Arm)
Lowest Pressure, Robotic-Assisted Laparoscopic Arm
干预措施: Carbon dioxide (Other)
10mmHg (Robotic-Assisted Laparoscopic Arm)
Lowest Pressure, Robotic-Assisted Laparoscopic Arm
干预措施: Bupivacaine (Drug)
10mmHg (Robotic-Assisted Laparoscopic Arm)
Lowest Pressure, Robotic-Assisted Laparoscopic Arm
干预措施: Oxycodone (Drug)
结局指标
主要结局
Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10)
时间窗: Postoperatively, before discharge from PACU (postoperative day 0)
The numerical rating scale is a pain screening tool that is routinely used to assess pain severity in the postoperative setting using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
次要结局
- Total number of 5mg oxycodone pills taken in the 2 weeks following discharge(Assessed at postoperative day 14)
- First reported pain score in PACU (numerical rating scale, 0-10)(Immediately upon arrival to PACU (postoperative day 0))
- Conversion to laparotomy(Intraoperative)
- Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10)(Immediately prior to discharge from PACU (postoperative day 0))
- Estimated blood loss(Intraoperative)
- Intraoperative complications(Intraoperative)
- Postoperative length of stay(Postoperatively, before discharge from PACU (postoperative day 0))
- Need for adjustment of insufflation pressure(Intraoperative)
- Operative time(Intraoperative)
- Surgeon-reported adequacy of assigned insufflation pressure(Immediately following surgery)
- Inpatient morphine milligram equivalents(Day of surgery (postoperative day 0))
- Need for insufflation pressure increase intra-operatively due to inadequate visualization(Intraoperative)
研究者
Matthew Siedhoff, MD MSCR
Vice Chair for Gynecology
Cedars-Sinai Medical Center