Preoperative Gabapentine for Carpal Tunnel

Effect of Preoperative Gabapentine for Carpal Tunnel Syndrome

The purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: Gabapentine; Other: Sugar pill

Detailed Description

There was studied 40 patients. Group 1 patients received 600 mg of gabapentin 1 hour before surgery; G2 received placebo 1 hour before surgery.

Anesthesia was regional intravenous block. Postoperative analgesia when needed was with acetaminophen. If needed was administered codeine. The evaluation of neuropathic pain was made by DN4 questionnaire. Pain intensity was assessed by numeric scale at block and after 30min, 1h, 2h, 2wk, 4wk, 6m. It was noted the duration of analgesia, and the amount of acetaminophen and codeine.

The statistical program used for analysis of the results was the Instat Graph

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• carpal tunnel syndrome

Exclusion Criteria:

• disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: preoperative gabapentine,; Gabapentine	Drug: Gabapentine; Gabapentine 600 mg 01 dose; Other Names: Anticonvulsant
Placebo Comparator: sugar pill; Placebo group	Other: Sugar pill; Sugar pill 01 dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Pain	Numerical score from 0 to 10 scale: Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain)	6 months

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Study Director: Rioko K Sakata, PhD, Universidade Federal de Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 28, 2012
• First Submitted That Met QC Criteria: June 29, 2012
• First Posted (Estimate): July 2, 2012

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: postoperative pain; gabapentine
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Antimanic Agents; Gabapentin; Anticonvulsants
• Other Study ID Numbers: CEP 0223/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No