Preoperative Gabapentine for Carpal Tunnel

NCT01632215 | Completed Phase 3 Results

• 1 other identifier: CEP 0223/09
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Carpal Tunnel Syndrome

Keywords

gabapentine; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain

  6 months

Secondary Outcomes (1)

• Chronic Pain

  6 months

Study Arms (2)

preoperative gabapentine,

EXPERIMENTAL

Gabapentine

Drug: Gabapentine

sugar pill

PLACEBO COMPARATOR

Placebo group

Other: Sugar pill

Interventions

Gabapentine DRUG

Gabapentine 600 mg 01 dose

Also known as: Anticonvulsant

preoperative gabapentine,

Sugar pill OTHER

Sugar pill 01 dose

sugar pill

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• carpal tunnel syndrome

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Pain, Postoperative

Interventions

Gabapentin; Anticonvulsants; Sugars

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Carbohydrates

Results Point of Contact

• Title: Dr. Rioko K. Sakata
• Organization: Federal University of São Paulo

riokoks.dcir@epm.br

055 11 5084 7463

Study Officials

• Rioko K Sakata, PhD

  Universidade Federal de São Paulo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pain Clinic Director

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 2, 2012
• Study Start: March 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: March 1, 2012
• Last Updated: March 5, 2019
• Results First Posted: June 4, 2014

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share