Use of Pre-Emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery

NCT02409498 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-04-25

No results posted yet for this study

Summary

The purpose of this study is to determine the effectiveness of perineal pain control via injection of a local anesthetic to numb the pudendal nerve. The medication which is commonly used for this block is called marcaine. This is called a pudendal block it has been used in obstetrical and gynecologic surgeries for several decades. The goal of this study is to reduce the amount of pain medications taken post operatively after pelvic reconstructive surgery. Subjects undergoing pelvic reconstructive surgery will be recruited during the pre-op visit. Subjects will be asked about their pain level in the PACU and also asked to document their pain score days 1 and 2 post op. They will also be asked to keep a medication log for 14 days post op.

Conditions

  • Pelvic Organ Prolapse

Interventions

DRUG

pudendal block

preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine.

DRUG

no pudendal block

preemptive pudendal nerve blockade with 10 ml of normal saline to each side

Sponsors & Collaborators

Principal Investigators

  • Mamta Mamik, 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
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02409498 on ClinicalTrials.gov