Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery
NEFOPAM
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
This study analyses interest of iv nefopam in combination with paracetamol after major abdominal surgery because the effect of morphine-sparing is discussed when combined these agents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2007
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2007
CompletedFirst Submitted
Initial submission to the registry
July 25, 2018
CompletedFirst Posted
Study publicly available on registry
August 8, 2018
CompletedDecember 1, 2025
August 1, 2018
24 days
July 25, 2018
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Estimate morphine consumption
mg
over 48 hours
Study Arms (2)
control group
PLACEBO COMPARATORNefopam group
EXPERIMENTALInterventions
The nefopam group received 120 mg nefopam (Acupan, Pharmbio, France) by continuous iv infusion over the study period (48h)
The Control group received 120 mg placebo infusion (saline solution) by continuous iv infusion over the study period (48h).
Eligibility Criteria
You may qualify if:
- Adult patient with a score ASA between I and III
- Patient scheduled for elective major abdominal surgery (by laparotomy) for cancer or diverticulosis
- Patient that signed the consent form
You may not qualify if:
- \- Patient treated in emergency situation
- Patient with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- Patient that needs a surgery for restoration of continuity
- Patient pregnant, breastfeeding, or during periods of genital activity using no contraception.
- Patient with contraindications to nefopam, morphine, or paracetamol
- Patient with chronic obstructive pulmonary disease, renal or severe hepatic impairment
- Patient under analgesics treatment
- Patient who participated in a clinical study in the previous 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Cuvillon P, Zoric L, Demattei C, Alonso S, Casano F, L'hermite J, Ripart J, Lefrant JY, Muller L. Opioid-sparing effect of nefopam in combination with paracetamol after major abdominal surgery: a randomized double-blind study. Minerva Anestesiol. 2017 Sep;83(9):914-920. doi: 10.23736/S0375-9393.17.11508-7. Epub 2017 Feb 13.
PMID: 28192892RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques RIPART, Dr
Nîmes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2018
First Posted
August 8, 2018
Study Start
June 1, 2007
Primary Completion
June 25, 2007
Study Completion
June 25, 2007
Last Updated
December 1, 2025
Record last verified: 2018-08