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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT00678314
First received: May 13, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on July 24, 2014