Preoperative Gabapentine for Carpal Tunnel

NCT01632215 — Phase 3, Completed, 40 participants, Federal University of São Paulo

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Effect of Preoperative Gabapentine for Carpal Tunnel Syndrome

Registry	NCT01632215
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	40 (Actual)
Sponsor	Federal University of São Paulo (Other)
Conditions	Carpal Tunnel Syndrome
Interventions	Gabapentine, Sugar pill (Drug, other)
Dates	start 2010-03-01, primary completion 2011-08-01, completion 2012-03-01, first posted 2012-07-02, last updated 2019-03-05

-Summary

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

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+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

+Arms and interventions

Arm	Type	Interventions	Description
preoperative gabapentine,	Experimental	Drug: Gabapentine	Gabapentine
sugar pill	Placebo comparator	Other: Sugar pill	Placebo group

Gabapentine (Drug), also known as Anticonvulsant: Gabapentine 600 mg 01 dose
Sugar pill (Other): Sugar pill 01 dose

+Outcome measures

Primary outcomes

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

Secondary outcomes

Chronic Pain [6 months]: Numerical score from 0 to 10 scale: Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain)

+Eligibility

Sex: All, ages: 18 Years to 60 Years

Inclusion Criteria:

* carpal tunnel syndrome

Exclusion Criteria:

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

+Posted results

Participant flow

Milestone	Preoperative Gabapentine,	Sugar Pill
Started	20	20
Completed	18	19
Not completed	2	1

Outcome results

Pain Intensity (Primary), Mean, units on a scale: Preoperative Gabapentine, 0.3 +/- 0.8; Sugar Pill 0.4 +/- 1.8
Chronic Pain (Secondary), Mean, points: Preoperative Gabapentine, 5.5 +/- 2.7; Sugar Pill 6.9 +/- 2.5 (p <0.05)

Adverse events

Time frame: 6 months

Arm	Deaths	Serious adverse events	Other adverse events
Preoperative Gabapentine,	0	0/20 (0.0%)	0/20 (0.0%)
Sugar Pill	0	0/20 (0.0%)	0/20 (0.0%)

+Investigators

Rioko K Sakata, PhD, Study director, Universidade Federal de São Paulo