Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension

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

Status

Withdrawn

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01441531

Enrollment

Registered

2011-09-27

Start date

2012-01-31

Completion date

2014-06-30

Last updated

2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourniquet-induced Hypertension, Tourniquet-induced Pain

Keywords

narcotic use, Other Acute Pain

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.

Interventions

DRUGgabapentin 600 mg po

Given one hour before surgery

DRUGPlacebo pill given one hour before surgery

Placebo pill given

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of tourniquet-induced hypertension	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

Measure	Time frame	Description
Postoperative pain	24 hours	Postoperative pain scores for 24 hours after surgery
Narcotic use	24 hours	Total use of morphine, vicodin during 24 hours after surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026