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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678314
• Other study ID #: LMV 151:2003/9759
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2008
• Last updated: May 13, 2008
• Start date: January 2004
• Est. completion date: February 2006

Study information

• Verified date: May 2008
• Source: University Hospital Orebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with clinically established carpel tunnel syndrome

• Surgery performed under local anesthesia

Exclusion Criteria:

• Chronic pain requiring analgesics

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Drug:
• Ropivacaine 0.2%
10 ml
• Ropivacaine 0.75%
3 ml
• Normal saline
10 ml

Locations

Country	Name	City	State
Sweden	Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Orebro

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 h	No
Secondary	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.		Up to 1 yr after surgery	Yes