Condition category
Surgery
Date applied
27/08/2004
Date assigned
27/08/2004
Last edited
13/08/2009
Prospective/Retrospective
Retrospectively 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 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 measures

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

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

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15367329

Publication citations

  1. 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.

Additional files

Editorial Notes