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临床试验/NCT06842771
NCT06842771尚未招募4 期

Pain with Differing Intraperitoneal Washes At the End of Laparoscopic Gynecologic Surgery

University of Tennessee1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年3月最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
96
试验地点
1
主要终点
subjective pain scores

研究概览

简要总结

We hypothesize that instilling intraperitoneal Marcaine (without epinephrine) at the end of a non-total laparoscopic gynecologic surgery (adnexa only, which includes the ovaries, fallopian tubes, and associated ligaments, vessels, and connective tissue) will result in less pain and reduced opioid use postoperatively.

详细描述

Minimally invasive gynecologic surgery has been shown to reduce postoperative pain, length of hospital stay, and prescription opioid use when compared to open procedures. However, postoperative abdominal pain is still significant, and the ways in which this pain can be reduced requires further exploration.

It is standard procedure to inject the surgical incision sites with long-acting analgesics such as Marcaine or Ropivacaine. However, intraperitoneal instillation of these pain medications and their effect on postoperative pain and prescription opioid use has only minimally been explored thus far.

In a retrospective cohort study, the effectiveness of administering intraperitoneal bupivacaine on decreasing postoperative pain in patients undergoing minimally invasive gynecologic surgery was evaluated. For the 130 patients included in the study, those who received the intraperitoneal bupivacaine "had lower median narcotic use on the day of surgery and the first postoperative day, compared with those who did not receive intraperitoneal bupivacaine".

Given these results, we believe that it will be beneficial to include the use of intraperitoneal anesthetics for patients receiving laparoscopic gynecologic surgery (adnexa only, which includes the ovaries, fallopian tubes, and associated ligaments, vessels, and connective tissue).

Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% was chosen for this study because this was used in previous studies, and it is used for analgesia at the trocar incisions during the laparoscopic procedure. The extra Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% will, therefore, be available for use instead of being discarded. The use of Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% will not incur any additional cost. Similarly, normal saline is used routinely during these types of surgical procedures, is available post-operatively for use as an intraperitoneal wash instead of being discarded. The participants will be randomized to Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% or normal saline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 years and older
  • Undergoing planned laparoscopic adnexal surgery as a day surgery procedure; The surgical site is the "adnexa" which contains the ovaries, fallopian tubes, and associated ligaments, vessels, and connective tissue. The "adnexa" does not include the uterus.
  • BMI 55.0 or less

排除标准

  • Under age 18
  • Undergoing a non-laparoscopic unplanned surgical procedure Patients having a laparoscopic partial or complete removal of the uterus, a hysterectomy, will NOT be included in this study population for enrollment.
  • septicemia
  • severe hemorrhage
  • severe hypotension or shock
  • arrhythmias
  • known hypersensitivity to bupivacaine or to any other local anesthetic agent
  • local infection at the injection site

研究组 & 干预措施

Normal saline intraperitoneal wash post procedure

Active Comparator

The control group (standard care) will receive an intraperitoneal wash with a fixed amount of saline.

干预措施: Normal Saline (0.9% NaCl) (Other)

Marcaine hydrochloride without epinephrine 0.5% intraperitoneal wash

Active Comparator

The experimental group (comparison treatment) will receive an intraperitoneal wash with 20 mL of Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% at the end of surgery.

干预措施: Marcaine hydrochloride without epinephrine 0.5% (Drug)

结局指标

主要结局

subjective pain scores

时间窗: At approximately 24 hours after surgery completion

At approximately 24 hours after surgery completion, we will contact the participant in person if still hospitalized, or via telephone if discharged home, to ask what their pain level is (utilizing the VAS) and how many opioid tablets (mg dosage and number) they have used since hospital discharge.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Schorge,MD

OB/GYN Chair and Professor

University of Tennessee

研究点 (1)

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