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Management of Postoperative Pain After Total Hip Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Chang Gung Memorial Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01040273
First received: December 20, 2009
Last updated: December 27, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Osteoarthritis of Hip
 Drug: Bupivacaine
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Pain VAS score [ Time Frame: pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional score: WOMAC hip score, SF-36 [ Time Frame: Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks ] [ Designated as safety issue: No ]

Study Start Date: December 2009
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experiment
Anesthetics intraarticular injection
 Drug: Bupivacaine
Placebo Comparator: Placebo
saline intraarticular injection
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040273

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

Locations
Taiwan
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01040273     History of Changes
Other Study ID Numbers: THA
Study First Received: December 20, 2009
Last Updated: December 27, 2009
Health Authority: Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013