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Management of Postoperative Pain After Total Hip Arthroplasty

Primary Purpose

Osteoarthritis of Hip

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Bupivacaine
Placebo
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Hip

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experiment

Placebo

Arm Description

Anesthetics intraarticular injection

saline intraarticular injection

Outcomes

Primary Outcome Measures

Pain VAS score

Secondary Outcome Measures

Functional score: WOMAC hip score, SF-36

Full Information

First Posted
December 20, 2009
Last Updated
December 27, 2009
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01040273
Brief Title
Management of Postoperative Pain After Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
Experiment
Arm Type
Experimental
Arm Description
Anesthetics intraarticular injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
saline intraarticular injection
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Functional score: WOMAC hip score, SF-36
Time Frame
Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dave W. Chen, M.D.
Phone
886-3-3281200
Ext
2420
Email
mr5181@adm.cgmh.org.tw
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kweishian
State/Province
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dave W. Chen, M.D.
Phone
886-3-3281200
Ext
2420
Email
mr5181@adm.cgmh.org.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
24439998
Citation
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.
Results Reference
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Management of Postoperative Pain After Total Hip Arthroplasty

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