- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01378949
Psoas Compartment Block Versus Fascia Iliaca Block After Total Hip Arthroplasty
June 22, 2011 updated by: Hillel Yaffe Medical Center
A psoas compartment block has been used with good results for postoperative pain relief after total hip arthroplasty (THA).
However, case reports describing serious complications after the use of this block, have been reported.
The fascia iliaca compartment block (FICB) has been shown to be a reliable block for postoperative pain relief for procedures and injuries involving the hip.
The investigators have not found any literature that has compared these two blocks.
This study will compare the two blocks when used for post-operative pain relief after THA.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hadera, Israel, 38100
- Hillel Yaffe Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA Class I-III
- Patients undergoing THA for osteoarthritis
Exclusion Criteria:
- Skin infections adjacent to block site
- Allergy to local analgesics
- Patient unable to understand visual analogue scale (VAS)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PsCB Group
Ultrasound-Guided Psoas Compartment Block will be used in patients for pain relief after THA
|
Bupivacaine 0.5% with adrenaline 5 mcg/cc
|
|
Active Comparator: FICB Group
Ultrasound-Guided Fascia Iliaca Compartment Block will be used in patients for pain relief after THA
|
Bupivacaine 0.5% with adrenaline 5 mcg/cc
|
|
Active Comparator: Patient-Controlled Analgesia
Patient-controlled analgesia will be used for pain relief after THA
|
Morphine 1 mg/cc
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain score of patients who have been given FICB for post-operative pain relief after THA
Time Frame: 3 days
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Anticipated)
September 1, 2013
Study Completion (Anticipated)
September 1, 2013
Study Registration Dates
First Submitted
June 19, 2011
First Submitted That Met QC Criteria
June 22, 2011
First Posted (Estimate)
June 23, 2011
Study Record Updates
Last Update Posted (Estimate)
June 23, 2011
Last Update Submitted That Met QC Criteria
June 22, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2259-11-HYMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.