Colonic Neoplasms, Diverticulosis, Colonic
Conditions
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.
Interventions
DRUGNefopam
The nefopam group received 120 mg nefopam (Acupan, Pharmbio, France) by continuous iv infusion over the study period (48h)
OTHERsaline solution
The Control group received 120 mg placebo infusion (saline solution) by continuous iv infusion over the study period (48h).
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* \- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate morphine consumption | over 48 hours | mg |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJacques RIPART, Dr
Nîmes University Hospital
Outcome results
None listed