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临床试验/NCT04996251
NCT04996251已完成4 期

Clinical Effectiveness of Pre-incision Versus Post-incision Local Anesthetic During Laparoscopic/Robotic Sacrocolpopexy

Northwell Health1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2021年7月30日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
129
试验地点
1
主要终点
Likert-pain Scale Score on Postoperative Day One

研究概览

简要总结

Obtaining Likest-pain scale score on postoperative day one after injection of local anesthetic into incision sites of a laparoscopic/robotic-assisted sacrocolpopexy

详细描述

Pelvic organ prolapse is becoming more common as women's life expectancy is increasing and the prevalence of obesity is rising. Many women undergo pelvic reconstructive surgery to treat their prolapse and improve their quality of life. The incidence of pelvic organ prolapse is 1.5-1.8 surgeries per 1,000 women years. Approximately 300,000 pelvic reconstructive surgeries are performed each year in the United States. There is a wide variety in surgical approaches and procedures for prolapse. One such procedure is a sacrocolpopexy in which the cervix or vaginal cuff is lifted to the anterior longitudinal ligament overlying the sacrum via a mesh graft. This can be done in a minimally invasive fashion with a laparoscopic or robotic approach or in an open abdominal approach. Numerous studies have shown this procedure to have a high success rate and long-term durability. As robotic/laparoscopic approach to surgery has shown shorter hospital-stays and improved patient outcomes, the robotic-assisted sacrocolpopexy has been rapidly incorporated into clinical practice.

In general, surgery causes a release of painful chemical mediators which has led to increased narcotic use, increased narcotic addiction, and number of pills prescribed. Most individuals who undergo surgery will require narcotics postoperatively to control their pain and some individuals have to extend their hospital stay until adequate pain control is achieved. Our study is aimed to reduce narcotic use, decrease hospital stay due to pain issues and determine if timing of adjunct pain medication improves pain scales for patients.

As postoperative pain after minimally invasive surgery is complex, specialists suggest that the effective analgesic treatment should be a multimodal approach. Use of local anesthetic with bupivacaine at robotic/laparoscopic trocar sites is the standard of care, however, there is no standard as to optimal timing that is most beneficial for patients to decrease pain. Currently, bupivacaine is used by providers at the trocar sites at either the beginning of the case or at the end of the case. From clinical observation, it appears that postoperative pain levels reported from patients receiving either at the beginning of surgery (pre-) or end (post-incision) of the surgery are similar. This study aims to examine the difference in postoperative day one pain levels reported by patients between the two infiltration methods

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)

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

  • Females 18+ years old who are undergoing robotic/laparoscopic assisted sacrocolpopexy
  • With/without hysterectomy
  • With/without unilateral/bilateral salpingectomy
  • With/without unilateral/bilateral oophorectomy
  • With/without mid-urethral sling
  • With/without anterior/posterior vaginal repair
  • English or Spanish speaking
  • Weight ≥ 120 lb

排除标准

  • Females < 18 years old
  • Chronic pelvic pain/chronic pain syndromes
  • Fibromyalgia
  • Pregnant or breastfeeding patients
  • Concomitant procedure for hernia repair or rectal prolapse repair
  • Undergoing primary vaginal prolapse surgery
  • Contraindications to taking the following medications: Bupivacaine
  • Patients who weight is < 120lb
  • Hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formulation
  • Pudendal or spinal nerve block given during surgery

研究组 & 干预措施

subcutaneous infiltration pre-incision

Experimental

Marcaine (bupivacaine) injected in the umbilical port site subcutaneously, while in the other 4 sites injection under direct visualization

干预措施: Bupivacaine Injection (Drug)

subcutaneous infiltration post-incision

Experimental

local anesthetic infiltrated subcutaneously at the end of the procedure after trocar removal and after skin closure with suture

干预措施: Bupivacaine Injection (Drug)

结局指标

主要结局

Likert-pain Scale Score on Postoperative Day One

时间窗: 18-24 hours

Difference in Likert-pain scale score difference between pre-incision versus post-incision subcutaneous infiltration with 4-5 milliliters 0.25% Bupivacaine (0 is no pain; 10 is worst pain imaginable)

次要结局

  • Narcotic Usage(2 weeks)

研究者

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

Harvey Winkler, MD

System Chief of Urogynecology Division; Principal Investigator

Northwell Health

研究点 (1)

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