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Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery

NCT01534416 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2017-12-20

Study results available
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Summary

The purpose of this study is to determine the effectiveness of placing numbing medication around the cervix prior to performing laparoscopic gynecologic surgery in decreasing pain after surgery. The study focuses on laparoscopic hysterectomies and robotic-assisted myomectomies. It will assess whether patients who receive the medication experience less pain and require less pain medication post operatively and if it helps reduce the number of patients who require hospitalization for pain control following surgery.

Conditions

  • Postoperative Pain
  • Paracervical Block
  • Laparoscopic Gynecologic Surgery

Interventions

DRUG

Bupivacaine

Subjects are injected paracervically with 10 ml of 0.5% bupivacaine with 1:200000 units epinephrine prior to surgical incision.

DRUG

Normal Saline

Subjects are injected paracervically with 10 ml of normal saline prior to surgical incision.

Sponsors & Collaborators

Principal Investigators

  • Charles Ascher-Walsh, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01534416 on ClinicalTrials.gov