CClinicalTrials.gg
WithdrawnNCT02927405Updated May 25, 2021

Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain

A Phase 4 interventional study of Gabapentin and TAP Block in Postoperative Pain, sponsored by State University of New York - Downstate Medical Center. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-25.

Sponsored by State University of New York - Downstate Medical Center · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Did not get the study to take off, did not recruit any subjects, and then closed the study.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Postoperative Pain

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Keywords

  • gabapentin
  • TAP block
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

Browse Pain, Postoperative studies →

Lead sponsor

State University of New York - Downstate Medical Center is the lead sponsor of 28 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    TAP Block plus placebo

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

    Procedure: TAP Block

  • 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.

    Drug: Gabapentin · Procedure: TAP Block

Interventions

  • DrugGabapentin

    anticonvulsant drug that is used for neuropathic pain.

    Also known as: Neurontin

  • ProcedureTAP Block

    a procedure done anesthetize the anterior abdominal wall

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What researchers measure

Primary outcomes

  1. Post-operative morphine consumption

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

    Time frame: 24 hours after surgery.

Secondary outcomes

  1. VAS Scores

    Visual analog scale that rates a patient's pain

    Time frame: 24 hours after surgery

Other outcomes

  1. Incidence of nausea and vomiting

    How many times the patient reported nausea, and how many times they vomitted.

    Time frame: 24 hours after surgery

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Study locations

1 site
  • SUNY Downstate Medical Center
    Brooklyn, New York 11203, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02927405
Lead sponsor
State University of New York - Downstate Medical Center
Responsible party
Shantha Ganesan (Director, Pain Medicine, State University of New York - Downstate Medical Center) — Principal investigator
First posted
Oct 7, 2016
Start date
Mar 4, 2020 (estimated)
Primary completion
Mar 31, 2020 (estimated)
Completion
Mar 31, 2020 (estimated)
Last update
May 25, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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