Preoperative Gabapentine for Carpal Tunnel

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01632215
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Actual Duration (Months): 24

Study Details

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

• Study Type: Interventional
• 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: Mar 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain Intensity [6 months]

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

Secondary Outcome Measures

1. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• carpal tunnel syndrome

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Federal University of São Paulo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jul 2, 2012
• Last Update Posted: Mar 5, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Rioko Kimiko Sakata, Pain Clinic Director, Federal University of São Paulo: gabapentine; postoperative pain
• Additional relevant MeSH terms: Carpal Tunnel Syndrome; Syndrome; Gabapentin; Anticonvulsants

Study Results

Participant Flow

Arm/Group Title	Preoperative Gabapentine,	Sugar Pill
Arm/Group Description	Gabapentine Gabapentine: Gabapentine 600 mg 01 dose	Placebo group Sugar pill: Sugar pill 01 dose
Period Title: Overall Study
STARTED	20	20
COMPLETED	18	19
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Preoperative Gabapentine,	Sugar Pill	Total
Arm/Group Description	Gabapentine Gabapentine: Gabapentine 600 mg 01 dose	Placebo group Sugar pill: Sugar pill 01 dose	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	51.5	52.1	51.8
Sex: Female, Male (Count of Participants)
Female	20 100%	20 100%	40 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preoperative Gabapentine,	Sugar Pill
Arm/Group Description	Gabapentine Gabapentine: Gabapentine 600 mg 01 dose	Placebo group Sugar pill: Sugar pill 01 dose
Measure Participants	18	19
Mean (Standard Deviation) [units on a scale]	0.3 (0.8)	0.4 (1.8)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preoperative Gabapentine,	Sugar Pill
Arm/Group Description	Gabapentine Gabapentine: Gabapentine 600 mg 01 dose	Placebo group Sugar pill: Sugar pill 01 dose
Measure Participants	20	20
30 minutes after surgery	5.5 (2.7)	6.9 (2.5)
1 hour after surgery	2.4 (1.6)	3.4 (2.9)
2h after	0.3 (0.8)	0.6 (1.0)
2 weeks after	3.6 (3.4)	4.6 (3.1)
1 month after	3.2 (3.3)	3.6 (3.4)
3 months after	1.8 (3.0)	1.6 (2.7)
6 months after	1.3 (2.9)	1.2 (2.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preoperative Gabapentine,
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Preoperative Gabapentine,		Sugar Pill
Arm/Group Description	Gabapentine Gabapentine: Gabapentine 600 mg 01 dose		Placebo group Sugar pill: Sugar pill 01 dose
All Cause Mortality
	Preoperative Gabapentine,		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Preoperative Gabapentine,		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Preoperative Gabapentine,		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.