Management of Postoperative Pain After Total Hip Arthroplasty
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 20, 2009
CompletedFirst Posted
Study publicly available on registry
December 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedDecember 29, 2009
December 1, 2009
1 year
December 20, 2009
December 27, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Pain VAS score
pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs
Secondary Outcomes (1)
Functional score: WOMAC hip score, SF-36
Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks
Study Arms (2)
Experiment
EXPERIMENTALAnesthetics intraarticular injection
Placebo
PLACEBO COMPARATORsaline intraarticular injection
Interventions
Eligibility Criteria
You may qualify if:
- diagnosed for surgery of osteoarthritis of hip
- ability to tolerate surgery under general anesthesia.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Kweishian, Taoyuan, 333, Taiwan
Related Publications (1)
Chen DW, Hu CC, Chang YH, Lee MS, Chang CJ, Hsieh PH. Intra-articular bupivacaine reduces postoperative pain and meperidine use after total hip arthroplasty: a randomized, double-blind study. J Arthroplasty. 2014 Dec;29(12):2457-61. doi: 10.1016/j.arth.2013.12.021. Epub 2013 Dec 19.
PMID: 24439998DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 20, 2009
First Posted
December 29, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2010
Last Updated
December 29, 2009
Record last verified: 2009-12