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Management of Postoperative Pain After Total Hip Arthroplasty

NCT ID: NCT01040273

Last Updated: 2009-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis of Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experiment

Anesthetics intraarticular injection

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

Placebo

saline intraarticular injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Bupivacaine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Locations

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Chang Gung Memorial Hospital

Kweishian, Taoyuan, Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Dave W. Chen, M.D.

Role: CONTACT

Phone: 886-3-3281200

Email: [email protected]

Facility Contacts

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Dave W. Chen, M.D.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 24439998 (View on PubMed)

Other Identifiers

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THA

Identifier Type: -

Identifier Source: org_study_id