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临床试验/NCT04428320
NCT04428320Unknown不适用

The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery

The Cooper Health System1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年5月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
140
试验地点
1
主要终点
VAS analog scale on post-op day #1

研究概览

简要总结

Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor muscle injections with bupivacaine or no injection (standard of care) as a part of their surgical pain control

详细描述

Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive:

  1. Bilateral trans- vaginal pelvic floor levator ani muscle injections (trigger point injections) with bupivacaine:
  • 0.5% bupivacaine will be injected at several sites for a total of 5ml on each side of the pelvic floor, with each injection site no more than 1 ml (Bupivacaine was chosen by the study team because of it has a longer half life then other common local anesthetics. We plan to use the same anesthetic and dosage to standardize the protocol between patients. Other local anesthetics will not be used in addition to the bupivacaine administered for research purposes. We will limit the amount of intravenous lidocaine to less than 5mg/ kg).
  1. Control- No additional treatment (standard of care).

The patient will be blinded to their randomization (single blind). The post-operative pain regimen will be standardized when possible. Patients will receive a regimen of IV and oral narcotics and Ketorolac per our routine post-operative protocol. On discharge from the hospital, patients will be given prescriptions for a standard amount of oral narcotic, 20 tablets of oxycodone (150 morphine equivalents), and 30 tablets of 600mg ibuprofen.

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
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
否

入选标准

  • •Able to read English and give informed consent
  • •Undergoing VAGINAL pelvic reconstructive surgery for POP

排除标准

  • •Hypersensitivity or allergy to amide anesthetics
  • •Documented chronic pain condition
  • •o (back pain, pelvic pain, fibromyalgia, etc.)
  • •Bleeding disorder
  • •Connective tissue disorder
  • •Neuromuscular disorder
  • •Cardiac conduction abnormality or channelopathy
  • •Hepatic Impairment
  • •Renal Impairment
  • •History of, or current, narcotic or alcohol dependence
  • •History of pelvic radiation or gynecologic malignancy

研究组 & 干预措施

Bupivicaine pelvic floor muscle injection

Experimental

Five injections at pre-specified locations at pelvic floor muscle bilaterally after induction of general anesthesia for vaginal pelvic prolapse surgery

干预措施: Pelvic floor injection (Procedure)

Standard of care (no injection) preoperatively

No Intervention

No injection - standard analgesia

结局指标

主要结局

VAS analog scale on post-op day #1

时间窗: postop day #1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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