Comparative effect of intraoperative propacetamol administration versus placebo on morphine consumption after elective reduction mammoplasty
| ISRCTN | ISRCTN71723173 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71723173 |
| Protocol serial number | N/A |
| Sponsor | Fight Against Pain Committee (Comité de Lutte contre la Douleur [CLUD]) (France) |
| Funder | Henri Mondor Hospital (Hopital Henri Mondor) (France) - Department of Anaesthesiology |
- Submission date
- 27/08/2004
- Registration date
- 27/08/2004
- Last edited
- 13/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michele Binhas
Scientific
Scientific
Hopital Henri Mondor
Creteil
94010
France
| michele.binhas@hmn.ap-hop-paris.fr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Postoperative administration of paracetamol has been shown to decrease pain with a morphine sparing effect. However, the effect of propacetamol administered intra-operatively on post-operative pain and early postoperative morphine consumption has not been clearly evaluated. In order to evaluate the effectiveness of analgesic protocols in the management of post-operative pain, a standardized anesthesia protocol without long-acting opioids is crucial. Thus, for ethical reasons, the surgical procedure under general anesthesia with remifentanil as the only intraoperative analgesic must be associated with a moderate predictable postoperative pain. The present study was designed to evaluate the effect of intraoperative administration of propacetamol during remifentanil-based anesthesia on postoperative pain in patients undergoing reduction mammoplasty. The hypothesis was the reduction of postoperative morphine consumtion and pain after intraoperative administration of propacetamol |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Morphine consumption and postoperative pain after intraoperative administration of placebo or propacetamol |
| Intervention | Intraoperative administration of propacetamol or placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Propacetamol |
| Primary outcome measure(s) |
Cumulative dose of morphine administered in the recovery room. |
| Key secondary outcome measure(s) |
The secondary end-points were the pain score after tracheal extubation and one hour after, the delay for obtaining a Simplified Numerical Pain Scale (SNPS) less than 4, and the incidence of morphine side effects in the recovery room. |
| Completion date | 31/10/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 36 |
| Key inclusion criteria | 1. Informed consent adult women above 18 years 2. American Society of Anesthesiologists (ASA) I and II |
| Key exclusion criteria | 1. Preoperative use of analgesic drugs 2. Body mass index ≥ 35 3. American Society of Anesthesiology physical status ≥ 3 4. Sensitivity to paracetamol |
| Date of first enrolment | 01/03/2000 |
| Date of final enrolment | 31/10/2001 |
Locations
Countries of recruitment
- France
Study participating centre
Hopital Henri Mondor
Creteil
94010
France
94010
France
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 | 14/09/2004 | Yes | No |
