NCT00678314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
Last Updated

May 15, 2008

Status Verified

May 1, 2008

Enrollment Period

2 years

First QC Date

May 13, 2008

Last Update Submit

May 13, 2008

Conditions

Carpal Tunnel Syndrome

Keywords

AnestheticsLocalropivacaineSurgeryHandcarpel tunnelCarpal tunnel surgery

Outcome Measures

Primary Outcomes (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.

    24 h

Secondary Outcomes (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.

    Up to 1 yr after surgery

Study Arms (3)

Group A

ACTIVE COMPARATOR
Drug: Ropivacaine 0.2%

Group B

ACTIVE COMPARATOR
Drug: Ropivacaine 0.75%

Group C

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

Ropivacaine 0.2%DRUG

10 ml

Group A
Ropivacaine 0.75%DRUG

3 ml

Group B
Normal salineDRUG

10 ml

Group C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Chronic pain requiring analgesics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro University Hospital

Örebro, Örebro County, 701 85, Sweden

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Kurt Pettersson, MD, PhD

    Institution for Clinical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2008

First Posted

May 15, 2008

Study Start

January 1, 2004

Primary Completion

January 1, 2006

Study Completion

February 1, 2006

Last Updated

May 15, 2008

Record last verified: 2008-05

Locations

SE(1)