Contact information
Type
Scientific
Primary contact
Dr Michele Binhas
ORCID ID
Contact details
Hopital Henri Mondor
Creteil
94010
France
michele.binhas@hmn.ap-hop-paris.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Propacetamol
Primary outcome measure
Cumulative dose of morphine administered in the recovery room.
Secondary outcome measures
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.
Overall trial start date
01/03/2000
Overall trial end date
31/10/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Informed consent adult women above 18 years
2. American Society of Anesthesiologists (ASA) I and II
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
36
Participant 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
Recruitment start date
01/03/2000
Recruitment end date
31/10/2001
Locations
Countries of recruitment
France
Trial participating centre
Hopital Henri Mondor
Creteil
94010
France
Sponsor information
Organisation
Fight Against Pain Committee (Comité de Lutte contre la Douleur [CLUD]) (France)
Sponsor details
Hopital Henri Mondor
Creteil
94010
France
michele.binhas@hmn.ap-hop-paris.fr
Sponsor type
Other
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Henri Mondor Hospital (Hopital Henri Mondor) (France) - Department of Anaesthesiology
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
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15367329
Publication citations
-
Results
Binhas M, Decailliot F, Rezaiguia-Delclaux S, Suen P, Dumerat M, François V, Combes X, Duvaldestin P, Comparative effect of intraoperative propacetamol versus placebo on morphine consumption after elective reduction mammoplasty under remifentanil-based anesthesia: a randomized control trial [ISRCTN71723173]., BMC Anesthesiol, 2004, 4, 1, 6, doi: 10.1186/1471-2253-4-6.