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临床试验/NCT01480089
NCT01480089已完成4 期

Surgical Pain Control With Ropivacaine by Atomized Delivery

Loyola University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2011年11月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)

研究概览

简要总结

The purpose of this trial is to determine the effect of spraying a local anesthetic called Ropivacaine (numbing medicine) into the abdominal cavity prior to surgery. Ropivacaine is a local anesthetic used to block pain in the body. There are studies showing that Ropivacaine decreases the pain of surgery with minimally invasive (laparoscopic) appendix and gallbladder removal but has not been tried in robotic pelvic surgery.

详细描述

Practice guidelines from the American Society of Anesthesiologists peri-operative techniques for pain management have remained essentially unchanged over the last 10 years (3). Current acute pain-management strategies include 1.) Epidural or intrathecal opioids 2.) Patient-controlled devices delivering systemic opioids and 3.) Regional techniques such as peripheral nerve blocks and post-incisional infiltration with local anesthetics.

The use of epidural and systemic opioids results in significant side-effects such as post-operative nausea and ileus which often lead to increased hospital stay. The literature supporting the benefit of preincisional infiltration with anesthetics remains equivocal.

A recently published study describes the use of intraperitoneal Ropivacaine (2mh/kg) during laparoscopic appendectomy(4). The study was a randomized, double-blinded, placebo-controlled study using Ropivacaine (vs placebo) injected through the laparoscopic ports prior to the start of the appendectomy in 63 patients(4).

Patients treated with Ropivacaine had a significant decrease in visual analog pain scores post-operatively and had decreased narcotic use during their hospital stay compared to placebo. There were no side-effects found with the one-time use of the Ropivacaine.

The results of the above study and review of an additional 24 randomized controlled trials conducted from 1993-2003 are not felt to be generalizable to pelvic surgery where port placement and the operative procedures vary significantly. Hence this study was undertaken to investigate the role of intraperitoneal Ropivacaine as an adjuvant to muscle relaxants and narcotics at the time of pelvic surgery.

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, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Consent to undergo robotic assisted gynecologic or urologic surgery
  • Between the ages of 18 and 75
  • Able to consent, fill out study documents, and complete all study procedures and follow-up visits

排除标准

  • Patients with an allergy to local anesthetics
  • Patients with severe underlying cardiovascular, renal or hepatic disease
  • Pregnant patients

研究组 & 干预措施

Atomized Intraperitoneal Saline (AIS)

Placebo Comparator

Participants randomized to this arm will be given atomized intraperitoneal saline(AIS).

干预措施: Atomized Intraperitoneal Saline (AIS) (Drug)

Intraperitoneal Ropivacaine(AIR)

Active Comparator

Participants randomized to this arm will receive atomized intraperitoneal ropivacaine (AIR).

干预措施: Intraperitoneal Ropivacaine (AIR) (Drug)

结局指标

主要结局

Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)

时间窗: 2 hours after surgery

Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.

次要结局

  • Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)(12 hours after surgery)

研究者

发起方
Loyola University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Mueller

Associate Professor

Loyola University

研究点 (1)

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