Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain

NCT02927405 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 926072
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

gabapentin; TAP block

Outcome Measures

Primary Outcomes (1)

• Post-operative morphine consumption

  Total amount of morphine the patient need to control post-operative pain

  24 hours after surgery.

Secondary Outcomes (1)

• VAS Scores

  24 hours after surgery

Other Outcomes (1)

• Incidence of nausea and vomiting

  24 hours after surgery

Study Arms (2)

TAP Block plus placebo

PLACEBO COMPARATOR

Patients will only receive a TAP block procedure and then morphine consumption will be recorded.

Procedure: TAP Block

TAP Block plus gabapentin

EXPERIMENTAL

Patients will receive a TAP block procedure and take pre-operative oral Gabapentin and morphine consumption will me recorded after surgery.

Drug: Gabapentin; Procedure: TAP Block

Interventions

Gabapentin DRUG

anticonvulsant drug that is used for neuropathic pain.

Also known as: Neurontin

TAP Block plus gabapentin

TAP Block PROCEDURE

a procedure done anesthetize the anterior abdominal wall

TAP Block plus gabapentin; TAP Block plus placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pain Medicine

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 7, 2016
• Study Start: March 4, 2020
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)