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Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters
This study has been completed.
Sponsored by: University Hospital Orebro
Information provided by: University Hospital Orebro
ClinicalTrials.gov Identifier: NCT00678314
  Purpose

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 Intervention Phase
Carpal Tunnel Syndrome
Drug: Ropivacaine 0.2%
Drug: Ropivacaine 0.75%
Drug: Normal saline
Phase IV

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies
MedlinePlus related topics: Carpal Tunnel Syndrome
Drug Information available for: Sodium chloride Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters

Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 88
Study Start Date: January 2004
Study Completion Date: February 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A: Active Comparator Drug: Ropivacaine 0.2%
10 ml
Group B: Active Comparator Drug: Ropivacaine 0.75%
3 ml
Group C: Placebo Comparator Drug: Normal saline
10 ml

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678314

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

Responsible Party: Institution for Clinical Medicine ( Dr Kurt Pettersson )
Study ID Numbers: LMV 151:2003/9759
Study First Received: May 13, 2008
Last Updated: May 13, 2008
ClinicalTrials.gov Identifier: NCT00678314  
Health Authority: Sweden: Medical Products Agency

Keywords provided by University Hospital Orebro:
Anesthetics
Local
ropivacaine
Surgery
Hand
carpel tunnel
Carpal tunnel surgery

Study placed in the following topic categories:
Carpal Tunnel Syndrome
Ropivacaine
Roussy Levy hereditary areflexic dystasia
Charcot-Marie-Tooth Disease
Wounds and Injuries
Disorders of Environmental Origin
Mononeuropathies
Nerve Compression Syndromes
Tomaculous neuropathy
Neuromuscular Diseases
Peripheral Nervous System Diseases
Hereditary Motor and Sensory Neuropathies
Charcot Marie Tooth disease
Cumulative Trauma Disorders
Sprains and Strains

Additional relevant MeSH terms:
Median Neuropathy
Disease
Nervous System Diseases
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anesthetics, Local
Pharmacologic Actions
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Syndrome
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009