Management of Postoperative Pain After Total Hip Arthroplasty

Osteoarthritis of Hip Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01040273
• Other study ID #: THA
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: December 20, 2009
• Last updated: December 27, 2009
• Start date: December 2009

Study information

• Verified date: December 2009
• Source: Chang Gung Memorial Hospital
• Contact: Dave W. Chen, M.D.
• Phone: 886-3-3281200
• Email: mr5181[@]adm.cgmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Osteoarthritis of Hip
• Osteoarthritis, Hip

Intervention

Drug:
• Bupivacaine

• Placebo

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kweishian	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain VAS score		pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs	No
Secondary	Functional score: WOMAC hip score, SF-36		Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks	No