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

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ClinicalTrials.gov Identifier: NCT00678314
Recruitment Status : Completed
First Posted : May 15, 2008
Last Update Posted : May 15, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: Ropivacaine 0.2% Drug: Ropivacaine 0.75% Drug: Normal saline Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters
Study Start Date : January 2004
Primary Completion Date : January 2006
Study Completion Date : February 2006


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Group A Drug: Ropivacaine 0.2%
10 ml
Active Comparator: Group B Drug: Ropivacaine 0.75%
3 ml
Placebo Comparator: Group C Drug: Normal saline
10 ml


Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: 24 h ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Up to 1 yr after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Chronic pain requiring analgesics
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678314


Locations
Sweden
Örebro University Hospital
Örebro, Sweden, 701 85
Sponsors and Collaborators
Region Örebro County
Investigators
Principal Investigator: Kurt Pettersson, MD, PhD Institution for Clinical Medicine
More Information

Responsible Party: Dr Kurt Pettersson, Institution for Clinical Medicine
ClinicalTrials.gov Identifier: NCT00678314     History of Changes
Other Study ID Numbers: LMV 151:2003/9759
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: May 15, 2008
Last Verified: May 2008

Keywords provided by Region Örebro County:
Anesthetics
Local
ropivacaine
Surgery
Hand
carpel tunnel
Carpal tunnel surgery

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents