Comparative effect of intraoperative propacetamol administration versus placebo on morphine consumption after elective reduction mammoplasty

ISRCTN ISRCTN71723173
DOI https://doi.org/10.1186/ISRCTN71723173
Secondary identifying numbers N/A
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

Hopital Henri Mondor
Creteil
94010
France

Email michele.binhas@hmn.ap-hop-paris.fr

Study information

Study designRandomised placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesPostoperative 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) studiedMorphine consumption and postoperative pain after intraoperative administration of placebo or propacetamol
InterventionIntraoperative administration of propacetamol or placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Propacetamol
Primary outcome measureCumulative dose of morphine administered in the recovery room.
Secondary outcome measuresThe 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.
Overall study start date01/03/2000
Completion date31/10/2001

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants36
Key inclusion criteria1. Informed consent adult women above 18 years
2. American Society of Anesthesiologists (ASA) I and II
Key exclusion criteria1. 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 enrolment01/03/2000
Date of final enrolment31/10/2001

Locations

Countries of recruitment

  • France

Study participating centre

Hopital Henri Mondor
Creteil
94010
France

Sponsor information

Fight Against Pain Committee (Comité de Lutte contre la Douleur [CLUD]) (France)
Other

Hopital Henri Mondor
Creteil
94010
France

Email michele.binhas@hmn.ap-hop-paris.fr
ROR logo "ROR" https://ror.org/033yb0967

Funders

Funder type

Hospital/treatment centre

Henri Mondor Hospital (Hopital Henri Mondor) (France) - Department of Anaesthesiology

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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