Evaluation of effectiveness of pain control in patients after total hip replacement using the anaesthetic continuous-infusion device with bupivacaine
| ISRCTN | ISRCTN06050107 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06050107 |
| Protocol serial number | N/A |
| Sponsor | Republic of China National Science Council (Taiwan) |
| Funder | Republic of China National Science Council (Taiwan) |
- Submission date
- 03/03/2007
- Registration date
- 13/04/2007
- Last edited
- 09/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Dave Weichih Chen
Scientific
Scientific
Orthopaedic Department
Chang Gung Memorial Hospital
Taipei-Linkou Medical Center
5 Fu-Shing St., Kweishan
Taoyuan
333
Taiwan
| achih121@ms75.hinet.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Rrandomised double-blind placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Evaluation of effectiveness of pain control in patients after total hip replacement using the anaesthetic continuous-infusion device with bupivacaine |
| Study objectives | The Anaesthetic Continuous-Infusion Device (ACID) with bupivacaine is effective for post-Total Hip Replacement (THA) pain control. |
| Ethics approval(s) | Approval received from the Institutional Review Board of the Chang Gung Memorial Hospital on the 25th December 2006 (ref: 95-1192B). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Bupivacaine |
| Primary outcome measure(s) |
Pain control |
| Key secondary outcome measure(s) |
Improve post-operative hip function and rehabilitation programs |
| Completion date | 31/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Total final enrolment | 92 |
| Key inclusion criteria | Consecutive 100 patients with indications for total hip replacement. |
| Key exclusion criteria | Patients who refuse to join the clinical trial. |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 31/07/2009 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Orthopaedic Department
Taoyuan
333
Taiwan
333
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | 09/05/2019 | Yes | No |
Editorial Notes
09/05/2019: Publication reference and total final enrolment added.
