Preoperative Gabapentine for Carpal Tunnel

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ClinicalTrials.gov Identifier: NCT01632215

Recruitment Status : Completed

First Posted : July 2, 2012

Results First Posted : June 4, 2014

Last Update Posted : March 5, 2019

Sponsor:

Information provided by (Responsible Party):

Rioko Kimiko Sakata, Federal University of São Paulo

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Carpal Tunnel Syndrome	Drug: Gabapentine Other: Sugar pill	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effect of Preoperative Gabapentine for Carpal Tunnel Syndrome
Actual Study Start Date :	March 2010
Actual Primary Completion Date :	August 2011
Actual Study Completion Date :	March 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Carpal tunnel syndrome

MedlinePlus related topics: Carpal Tunnel Syndrome

Drug Information available for: Gabapentin Gabapentin enacarbil

Genetic and Rare Diseases Information Center resources: Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsies Roussy Levy Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: preoperative gabapentine, Gabapentine	Drug: Gabapentine Gabapentine 600 mg 01 dose Other Name: Anticonvulsant
Placebo Comparator: sugar pill Placebo group	Other: Sugar pill Sugar pill 01 dose

Outcome Measures

Primary Outcome Measures :

Pain Intensity [ Time Frame: 6 months ]
Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain

Secondary Outcome Measures :

Chronic Pain [ Time Frame: 6 months ]
Numerical score from 0 to 10 scale:

Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

carpal tunnel syndrome

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632215

Sponsors and Collaborators

Federal University of São Paulo

Investigators

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Study Director:	Rioko K Sakata, PhD	Universidade Federal de São Paulo

More Information

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Responsible Party:	Rioko Kimiko Sakata, Pain Clinic Director, Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT01632215
Other Study ID Numbers:	CEP 0223/09
First Posted:	July 2, 2012 Key Record Dates
Results First Posted:	June 4, 2014
Last Update Posted:	March 5, 2019
Last Verified:	February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Rioko Kimiko Sakata, Federal University of São Paulo:


gabapentine postoperative pain

Additional relevant MeSH terms:

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Carpal Tunnel Syndrome Syndrome Disease Pathologic Processes Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries Gabapentin	Anticonvulsants Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents

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