Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension

Baylor College of Medicine

Status and phase: Withdrawn; Early Phase 1

Conditions: Tourniquet-induced Pain; Tourniquet-induced Hypertension

Treatments: Drug: Placebo pill given one hour before surgery; Drug: gabapentin 600 mg po

Study type: Interventional

Funder types: Other

Identifiers

NCT01441531

H-28860

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Description:

Gabapentin 600 mg po given 1 hour before surgery

Treatment:

Drug: gabapentin 600 mg po

Placebo sugar pill

Placebo Comparator group

Treatment:

Drug: Placebo pill given one hour before surgery