Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair

December 20, 2021 updated by: Dmitry Nepomnayshy, Lahey Clinic

A Randomized, Double-blinded, Placebo-controlled Trial of the Effects of Infusing Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair

To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair
  • American Society of Anesthesiology (ASA) Class I and II

Exclusion Criteria:

  • Conversion from laparoscopic to open surgery
  • History of Chronic pain or ongoing treatment for chronic pain
  • Age less than 18 yrs
  • Allergy to local anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anesthetic intervention
After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine.
Drug: 0.5% Bupivicaine
Local anesthetic
Other Names:
  • Marcaine
  • Sensorcaine
Placebo Comparator: Saline intervention
After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline.
Drug: 0.5% Bupivicaine
Local anesthetic
Other Names:
  • Marcaine
  • Sensorcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale Pain Score Assessment (VAS)
Time Frame: Post-operative period
Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain)
Post-operative period
Visual Analog Scale Pain Score Assessment (VAS)
Time Frame: Pain scale 3 days after surgery
Pain level recorded at 3 days after surgery. VAS scale measures pain in increments of whole numbers from 0 (no pain) to 10 (most sever pain imaginable)
Pain scale 3 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Pain Medication Used in Oral Morphine Equivalents
Time Frame: 4 hours after surgery
Total mg of opiate after surgery
4 hours after surgery
Duration of Narcotic Used to Control Pain
Time Frame: 4 weeks post-op
Number of days post-operatively narcotic is used
4 weeks post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lahey Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

October 16, 2019

Study Completion (Actual)

October 16, 2019

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 3, 2014

First Posted (Estimate)

February 4, 2014

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCID 2013-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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