Back to resultsPatient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Ropivacaine 0.2%
Ropivacaine 0.75%
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Anesthetics, Local, ropivacaine, Surgery, Hand, carpel tunnel, Carpal tunnel surgery
Eligibility Criteria
Inclusion Criteria:
- Patients with clinically established carpel tunnel syndrome
- Surgery performed under local anesthesia
Exclusion Criteria:
- Chronic pain requiring analgesics
Sites / Locations
- Örebro University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00678314
Brief Title
Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters
Official Title
Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Region Örebro County
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Anesthetics, Local, ropivacaine, Surgery, Hand, carpel tunnel, Carpal tunnel surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Title
Group B
Arm Type
Active Comparator
Arm Title
Group C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.2%
Intervention Description
10 ml
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.75%
Intervention Description
3 ml
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
10 ml
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with clinically established carpel tunnel syndrome
Surgery performed under local anesthesia
Exclusion Criteria:
Chronic pain requiring analgesics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Pettersson, MD, PhD
Organizational Affiliation
Institution for Clinical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Örebro University Hospital
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters
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