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Management of Postoperative Pain After Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT01040273
Recruitment Status : Unknown
Verified December 2009 by Chang Gung Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 29, 2009
Last Update Posted : December 29, 2009
Information provided by:
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Hip Drug: Bupivacaine Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2009
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experiment
Anesthetics intraarticular injection
Drug: Bupivacaine
Placebo Comparator: Placebo
saline intraarticular injection
Drug: Placebo

Primary Outcome Measures :
  1. Pain VAS score [ Time Frame: pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs ]

Secondary Outcome Measures :
  1. Functional score: WOMAC hip score, SF-36 [ Time Frame: Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040273

Contact: Dave W. Chen, M.D. 886-3-3281200 ext 2420 mr5181@adm.cgmh.org.tw

Chang Gung Memorial Hospital Not yet recruiting
Kweishian, Taoyuan, Taiwan, 333
Contact: Dave W. Chen, M.D.    886-3-3281200 ext 2420    mr5181@adm.cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01040273     History of Changes
Other Study ID Numbers: THA
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: December 29, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents