Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery

Not Applicable

Completed

• Conditions: Colonic Neoplasms; Diverticulosis, Colonic
• Interventions: Other: saline solution; Drug: Nefopam

• Registration Number: NCT03619538
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2018-07-25
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-02
• Last Update Submitted: 2018-08-02
• Study First Posted: 2018-08-08
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	saline solution	-
Nefopam group	Nefopam	-

Primary Outcome Measures

Name	Time	Method
Estimate morphine consumption	over 48 hours	mg