NCT01040273

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

December 29, 2009

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

December 20, 2009

Last Update Submit

December 27, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain VAS score

    pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs

Secondary Outcomes (1)

  • Functional score: WOMAC hip score, SF-36

    Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks

Study Arms (2)

Experiment

EXPERIMENTAL

Anesthetics intraarticular injection

Drug: Bupivacaine

Placebo

PLACEBO COMPARATOR

saline intraarticular injection

Drug: Placebo

Interventions

Experiment
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed for surgery of osteoarthritis of hip
  • ability to tolerate surgery under general anesthesia.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kweishian, Taoyuan, 333, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Dave W. Chen, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2009

First Posted

December 29, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Last Updated

December 29, 2009

Record last verified: 2009-12

Locations