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

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.

Study Overview

• Status: Completed
• Conditions: Colonic Neoplasms; Diverticulosis, Colonic
• Intervention / Treatment: Other: saline solution; Drug: Nefopam

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: control group	Other: saline solution; The Control group received 120 mg placebo infusion (saline solution) by continuous iv infusion over the study period (48h).
EXPERIMENTAL: Nefopam group	Drug: Nefopam; The nefopam group received 120 mg nefopam (Acupan, Pharmbio, France) by continuous iv infusion over the study period (48h)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate morphine consumption	mg	over 48 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jacques RIPART, Dr, Nîmes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2011
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Diverticulum; Diverticular Diseases; Diverticulosis, Colonic; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Nefopam
• Other Study ID Numbers: PHRC-I/2003/JYL-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No