Minocycline to Reduce Pain After Carpal Tunnel Release

May 10, 2018 updated by: Catherine Curtin, VA Palo Alto Health Care System

A Trial of Minocycline for Pain After Carpal Tunnel and Trigger Release

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Palo Alto VA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult, Veteran,

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: minocycline
perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID
Drug: Minocycline
RCT blinded placebo trial
Other Names:
  • Minocycline Hydrochloride
Placebo Comparator: Placebo
PLacebo
Drug: placebo
RCT blinded placebo trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Pain Resolution
Time Frame: up to 365 days
the time until patient answers no pain at surgical site for three consecutive days
up to 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Palo Alto Health Care System

Collaborators

Stanford University

Investigators

  • Principal Investigator: Catherine Curtin, MD, Palo Alto Veterans Hsopital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 26, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Actual)

June 11, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RX000487

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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