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Minocycline to Reduce Pain After Carpal Tunnel Release

Primary Purpose

Chronic Pain, Post-operative Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Minocycline
placebo
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult, Veteran,

Exclusion Criteria:

  • Kidney failure, Liver failure, thrombocytopenia, ALS, SLE, Frailty, unable to understand survery

Sites / Locations

  • Palo Alto VA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

minocycline

Placebo

Arm Description

perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID

PLacebo

Outcomes

Primary Outcome Measures

Time to Pain Resolution
the time until patient answers no pain at surgical site for three consecutive days

Secondary Outcome Measures

Full Information

First Posted
January 26, 2014
Last Updated
May 10, 2018
Sponsor
VA Palo Alto Health Care System
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02051296
Brief Title
Minocycline to Reduce Pain After Carpal Tunnel Release
Official Title
A Trial of Minocycline for Pain After Carpal Tunnel and Trigger Release
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
Collaborators
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators are looking at whether peri-operative minocycline will reduce the duration of pain after minor hand surgery: carpal tunnel release and trigger finger release. The investigators' hypothesis is that minocycline will reduce post-operative pain.
Detailed Description
This is a double blinded randomized controlled trial. Patients are given 100mg of minocycline 2 hours prior to their procedure and then 100mg two times a day for 5 days. The subjects are then contacted daily to check their level of pain. The investigators' outcome of interest is time to pain resolution. The investigators will perform a futility analysis to assess if a larger trial would be a reasonable next step after this pilot study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Post-operative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
minocycline
Arm Type
Experimental
Arm Description
perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
PLacebo
Intervention Type
Drug
Intervention Name(s)
Minocycline
Other Intervention Name(s)
Minocycline Hydrochloride
Intervention Description
RCT blinded placebo trial
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
RCT blinded placebo trial
Primary Outcome Measure Information:
Title
Time to Pain Resolution
Description
the time until patient answers no pain at surgical site for three consecutive days
Time Frame
up to 365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult, Veteran, Exclusion Criteria: Kidney failure, Liver failure, thrombocytopenia, ALS, SLE, Frailty, unable to understand survery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Curtin, MD
Organizational Affiliation
Palo Alto Veterans Hsopital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto VA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Minocycline to Reduce Pain After Carpal Tunnel Release

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