Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain

May 20, 2021 updated by: Shantha Ganesan, State University of New York - Downstate Medical Center
There is an increasing trend on decreasing narcotic use and maximizing efficiency in the perioperative care. There are no studies that have compared a TAP block versus a TAP block plus gabapentin for laparoscopic procures.This study will investigate if taking gabapentin and receiving a TAP block decrease post-operative morphine consumption. It will be a randomized controlled, double blind study, with 130 patients between 18-60 years; that will undergo laparoscopic GYN procedures. Secondary outcomes will look at the incidence of nausea, vomiting, and VAS (verbal analog scale) scores. This combination may be helpful because gabapentin will be used to decrease visceral and central pain, and TAP block will decrease somatic pain. Performing a multimodal approach may decrease narcotic consumption, adverse effects and improve pain management.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate 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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female
  • receiving laparoscopic GYN procedure
  • between 18-60

Exclusion Criteria:

  • are already taking gabapentin
  • have diabetic neuropathy
  • have a chronic pain syndrome
  • take opioids at home
  • are pregnant
  • have kidney disease
  • have an allergy to morphine

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
Placebo Comparator: TAP Block plus placebo
Patients will only receive a TAP block procedure and then morphine consumption will be recorded.
Procedure: TAP Block
a procedure done anesthetize the anterior abdominal wall
Experimental: TAP Block plus gabapentin
Patients will receive a TAP block procedure and take pre-operative oral Gabapentin and morphine consumption will me recorded after surgery.
Procedure: TAP Block
a procedure done anesthetize the anterior abdominal wall
Drug: Gabapentin
anticonvulsant drug that is used for neuropathic pain.
Other Names:
  • Neurontin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative morphine consumption
Time Frame: 24 hours after surgery.
Total amount of morphine the patient need to control post-operative pain
24 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Scores
Time Frame: 24 hours after surgery
Visual analog scale that rates a patient's pain
24 hours after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of nausea and vomiting
Time Frame: 24 hours after surgery
How many times the patient reported nausea, and how many times they vomitted.
24 hours after surgery

Collaborators and Investigators

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

Sponsor

State University of New York - Downstate Medical Center

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 (Anticipated)

March 4, 2020

Primary Completion (Anticipated)

March 31, 2020

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimate)

October 7, 2016

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 926072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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