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Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
TAP Block
Sponsored by
State University of New York - Downstate Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring gabapentin, TAP block

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • SUNY Downstate Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

TAP Block plus placebo

TAP Block plus gabapentin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

VAS Scores
Visual analog scale that rates a patient's pain

Full Information

First Posted
October 5, 2016
Last Updated
May 20, 2021
Sponsor
State University of New York - Downstate Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02927405
Brief Title
Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain
Official Title
Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Did not get the study to take off, did not recruit any subjects, and then closed the study.
Study Start Date
March 4, 2020 (Anticipated)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Downstate Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
gabapentin, TAP block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP Block plus placebo
Arm Type
Placebo Comparator
Arm Description
Patients will only receive a TAP block procedure and then morphine consumption will be recorded.
Arm Title
TAP Block plus gabapentin
Arm Type
Experimental
Arm Description
Patients will receive a TAP block procedure and take pre-operative oral Gabapentin and morphine consumption will me recorded after surgery.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
anticonvulsant drug that is used for neuropathic pain.
Intervention Type
Procedure
Intervention Name(s)
TAP Block
Intervention Description
a procedure done anesthetize the anterior abdominal wall
Primary Outcome Measure Information:
Title
Post-operative morphine consumption
Description
Total amount of morphine the patient need to control post-operative pain
Time Frame
24 hours after surgery.
Secondary Outcome Measure Information:
Title
VAS Scores
Description
Visual analog scale that rates a patient's pain
Time Frame
24 hours after surgery
Other Pre-specified Outcome Measures:
Title
Incidence of nausea and vomiting
Description
How many times the patient reported nausea, and how many times they vomitted.
Time Frame
24 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain

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