- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01040273
Management of Postoperative Pain After Total Hip Arthroplasty
Orthopedic surgery is reportedly among the most painful surgical procedures. Surgical damage following major orthopedic surgery often involves a large, deep incision with considerable tissue dissection and muscle, bone, and vascular exposure. Post-operative pain after such surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical costs.
We design a prospective randomized study for postoperative pain control following total hip arthroplasty.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Taoyuan
-
Kweishian, Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosed for surgery of osteoarthritis of hip
- ability to tolerate surgery under general anesthesia.
Exclusion Criteria:
- refusal or the lack of mental ability to provide informed consent
- neuropathic pain or sensory disorders in the leg requiring surgery
- previous surgery of the hip joint
- coagulation abnormalities
- severe renal or hepatic impairment
- chronic opioid users
- known history of intolerance to the drugs used in the study
Study Plan
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 |
---|---|
Experimental: Experiment
Anesthetics intraarticular injection
|
|
Placebo Comparator: Placebo
saline intraarticular injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain VAS score
Time Frame: pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs
|
pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional score: WOMAC hip score, SF-36
Time Frame: Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks
|
Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THA
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.
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