---
title: Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension
nct_id: NCT01441531
overall_status: WITHDRAWN
phase: EARLY_PHASE1
sponsor: Baylor College of Medicine
study_type: INTERVENTIONAL
primary_condition: Tourniquet-induced Pain
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01441531.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01441531"
ct_last_update_post_date: 2015-03-17
last_seen_at: "2026-05-12T07:10:38.313Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension

**Official Title:** Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension During Orif of Tibia Fracture Under General Anesthesia

**NCT ID:** [NCT01441531](https://clinicaltrials.gov/study/NCT01441531)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** Unable to recruit patient due to surgical case type. Not worth continuing study.
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Baylor College of Medicine
- **Conditions:** Tourniquet-induced Pain, Tourniquet-induced Hypertension
- **Start Date:** 2012-01
- **Completion Date:** 2014-06
- **CT.gov Last Update:** 2015-03-17

## Brief Summary

The purpose of the study is to find out if taking a dose of gabapentin 600 mg by mouth (po) before surgery will help prevent the development of tourniquet pain and hypertension while the tourniquet is inflated during orif of tibia fracture.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 64 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patient ages 18-64
* ASA physical status 1-3
* Schedule for orif tibia fracture with use of pneumatic tourniquet

Exclusion Criteria:

* Allergy to study medications
* polytrauma
* lower extremity crush injury
* chronic opioid use
* sickle cell disease or trait
* peripheral vascular disease
* poorly controlled hypertension
* history of DVT/PE
* morbid obesity (BMI \> 35)
* patient or surgeon refusal
* patient inability to properly describe postoperative pain to investigators
```

## Arms

- **Gabapentin** (EXPERIMENTAL) — Gabapentin 600 mg po given 1 hour before surgery
- **Placebo sugar pill** (PLACEBO_COMPARATOR)

## Interventions

- **gabapentin 600 mg po** (DRUG) — Given one hour before surgery
- **Placebo pill given one hour before surgery** (DRUG) — Placebo pill given

## Primary Outcomes

- **Incidence of tourniquet-induced hypertension** _(time frame: During the tourniquet inflation time period)_ — Primary outcome is incidence of tourniquet-induced hypertension, which is defined as an increase of systolic or diastolic blood pressure \> 30% from baseline. This will be looked at during the time of tourniquet inflation (from inflation to deflation) during the actual surgical procedure. Usual maximum inflation time is 120 minutes.

## Secondary Outcomes

- **Postoperative pain** _(time frame: 24 hours)_
- **Narcotic use** _(time frame: 24 hours)_

## Locations (1)

- Ben Taub General Hospital, Houston, Texas, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ben taub general hospital|houston|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01441531.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01441531*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*