Condition category
Musculoskeletal Diseases
Date applied
03/03/2007
Date assigned
13/04/2007
Last edited
13/04/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dave Weichih Chen

ORCID ID

Contact details

Orthopaedic Department
Chang Gung Memorial Hospital
Taipei-Linkou Medical Center
5 Fu-Shing St.
Kweishan
Taoyuan
333
Taiwan
achih121@ms75.hinet.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The Anaesthetic Continuous-Infusion Device (ACID) with bupivacaine is effective for post-Total Hip Replacement (THA) pain control.

Ethics approval

Approval received from the Institutional Review Board of the Chang Gung Memorial Hospital on the 25th December 2006 (ref: 95-1192B).

Study design

Rrandomised double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Osteoarthritic hip

Intervention

Group I (25 patients): ACID intra-articular (above lessor trochanter) and normal saline 100 ml
Group II (25 patients): ACID inter-muscular (between tensor facia lata and gluteal medius) and normal saline 100 ml
Group III (25 patients): ACID intra-articular (above lessor trochanter) and bupivacaine 0.5% 100 ml
Group IV (25 patients): ACID intra-articular (between tensor facia lata and gluteal medius) and bupivacaine 0.5%100 ml

Intervention type

Drug

Phase

Not Specified

Drug names

Bupivacaine

Primary outcome measures

Pain control

Secondary outcome measures

Improve post-operative hip function and rehabilitation programs

Overall trial start date

01/08/2007

Overall trial end date

31/07/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Consecutive 100 patients with indications for total hip replacement.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100 patients

Participant exclusion criteria

Patients who refuse to join the clinical trial.

Recruitment start date

01/08/2007

Recruitment end date

31/07/2009

Locations

Countries of recruitment

Taiwan

Trial participating centre

Orthopaedic Department
Taoyuan
333
Taiwan

Sponsor information

Organisation

Republic of China National Science Council (Taiwan)

Sponsor details

106 Ho-Ping East Road
Section 2
Taipei
106
Taiwan

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Republic of China National Science Council (Taiwan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes