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Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters

NCT ID: NCT00678314

Last Updated: 2008-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-02-28

Brief Summary

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This study was done with the primary aim of assessing the efficacy (as calculated by pain intensity difference) of patient controlled regional analgesia (PCRA) technique against oral analgesics, which has been the standard of care at our hospital. Secondary objectives were to analyze the volume and dose of LA that should be given, patient satisfaction and the long-term outcome for patients treated with the PCRA technique.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Keywords

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Anesthetics Local ropivacaine Surgery Hand carpel tunnel Carpal tunnel surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.2%

Intervention Type DRUG

10 ml

Group B

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.75%

Intervention Type DRUG

3 ml

Group C

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

10 ml

Interventions

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Ropivacaine 0.2%

10 ml

Intervention Type DRUG

Ropivacaine 0.75%

3 ml

Intervention Type DRUG

Normal saline

10 ml

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with clinically established carpel tunnel syndrome
* Surgery performed under local anesthesia

Exclusion Criteria

* Chronic pain requiring analgesics
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Institution for Clinical Medicine

Principal Investigators

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Kurt Pettersson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institution for Clinical Medicine

Locations

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Örebro University Hospital

Örebro, Örebro County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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LMV 151:2003/9759

Identifier Type: -

Identifier Source: org_study_id