A Randomized Controlled Trial (RCT) Comparing the Effect of Low Versus Standard Pressure Pneumoperitoneum on Post-operative Shoulder Tip Pain in Patients Undergoing Laparoscopic Gynecologic Surgery for Benign Indications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Shoulder Tip Pain
研究概览
简要总结
This proposed study is a single-center, double blind, parallel group RCT comparing the use of low (10 mm Hg) versus standard pressure (15 mm Hg) pneumoperitoneum at the time of benign gynecologic laparoscopic surgery. Patients will be randomized to the control group (standard pressure) or the intervention group (low pressure) and surgeons will be blinded to the study pressure. Data on post-operative recovery and pain scores will be recorded for each patient.
详细描述
Primary Objective: The primary objective of this study is to determine the effect of low (10 mm Hg) versus standard pressure (15 mm Hg) pneumoperitoneum on post-operative shoulder pain on post operative day one following laparoscopic gynecologic surgery for benign indication.
Secondary Objective: Secondary outcomes measured will include post-operative shoulder tip pain at 1 and 2 hours, QoR score (Appendix A) on POD 1, incidence of post-operative shoulder tip pain (defined as pain rating above zero) at 1, 2, and POD 1, generalized pain, nausea and bloating at 1 and 2 hours and POD 1, as well as rescue analgesia consumption before discharge and use up to POD1. The investigators will also measure intraoperative time, complication rates, estimated blood loss, surgeon visibility rating and anesthetist satisfaction rating, and time to patient discharge. Additionally, investigators will assess rate of failure to complete the surgery at designated pressure (i.e. request to increase pressure).
This proposed study is a single-center parallel group RCT comparing the use of low (10 mm Hg) versus standard pressure (15 mm Hg) pneumoperitoneum at the time of benign gynecologic laparoscopic surgery. Participants will be selected using a convenience sample from Women's College Hospital operating room list. All potentially eligible patients will be invited to participate in this study by the MIS fellow on the day of surgery up to 2 hours before the scheduled surgery. Study consent will be obtained by the MIS fellow or research assistant after the patient has had sufficient time to consider participation in the study.
The investigators will create a randomization list using a computer-generated allocation sequence in equal ratio with study numbers 1 to 82. A member of the research team who will have no interaction with patients in this study will prepare the low and standard pressure envelopes and label them according to the randomization list. Study participants will be randomized on the day of surgery, and the research nurse will set the insufflation pressure to the pre-randomized pressure identified in the envelope. The surgeon, research team, participants and data analysts will be blinded to treatment group. Patients will receive standardized peri-operative care during their operation.
Post-operative pain, nausea, and medication use will be assessed in the PACU. Patients will also be contacted on POD1 to assess post-operative pain scores, calculate total narcotic consumption and elicit any adverse events.
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
Study participants will be randomized on the day of surgery, and the research nurse will set the insufflation pressure to the pre-randomized pressure identified in the envelope. The surgeon, research team, participants and data analysts will be blinded to treatment group.
Study participants will be randomized on the day of surgery. After Veress-needle insufflation and laparoscopic port insertion at a pneumoperitoneum of 20mmHg (standard entry pressure), the patient will be placed in Trendelenberg position. At this time, the research nurse will set the insufflation pressure to the pre-set randomized number. This insufflation pressure will be blinded on the machine from the surgeon. If the surgeon is not satisfied with the visibility, they may ask to set the pressure to 15mmHg, however, they will remain blinded. The surgeon, research team, participants and data analysts will be blinded to treatment group.
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
- •The participant must meet all of the inclusion criteria to eligible for this clinical trial:
- •All ages > or = to 18 years old;
- •Must be deemed to have capacity to provide informed consent;
- •Must sign and date the informed consent form;
- •Stated willingness to comply with all study procedures;
- •Must be undergoing unilateral or bilateral salpingo-oopherectomy or salpingectomy or ovarian cystectomy;
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
- •Previous midline laparotomy;
- •Gynecological cancer beyond stage 1 disease;
- •Chronic pain;
- •Known diagnosis of endometriosis or evidence of endometriosis intra-operatively;
- •Fibromyalgia;
- •Language barrier;
- •Inability to communicate or provide informed consent;
研究组 & 干预措施
Standard Pressure
Patients undergoing laparosocpy at standard pressure (15 mm Hg)
干预措施: Standard Pressure Group (No intervention- active comparator) (Other)
Low Pressure
Patients undergoing experimental intervention of low pressure pneumoperitoneum (10 mm Hg)
干预措施: Low Pressure Penumoperitoneum (Procedure)
结局指标
主要结局
Shoulder Tip Pain
时间窗: Post-op day 1
The primary endpoint is post-operative shoulder tip pain measured on post-op day 1 following surgery by a self-administered NRS (numeric rating score) for pain, on a scale from 0 (no pain) to 10 (worst pain imaginable).
次要结局
- Shoulder Tip Pain (Short-term)(1 and 2 hours after surgery)
- Quality of Recovery (QoR) score(Post-op day 1)
- Generalized Pain Score(1, 2 hours post-op and post-op day 1)
- Incidence of Nausea and Vomitting(1, 2 hours post-op and post-op day 1)
- Narcotic use(Post-op day 1)
- Surgeon visibility(Duration of surgery)
- Anesthetist satisfaction(Duration of surgery)
- Surgical time(Duration of surgery (day surgery))
- Estimated blood loss(Duration of surgery (day surgery))
- Adverse Effect/Complications(Post-op day 1)
研究者
Mara Sobel
Associate Professor
Mount Sinai Hospital, Canada