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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Completed
• CT.gov ID: NCT03619538
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Actual Duration (Months): 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms; Diverticulosis, Colonic	Drug: Nefopam; Other: saline solution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery
• Actual Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Estimate morphine consumption [over 48 hours]

   mg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Jacques RIPART, Dr, Nîmes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT03619538
• Other Study ID Numbers: PHRC-I/2003/JYL-01
• First Posted: Aug 8, 2018
• Last Update Posted: Aug 8, 2018
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colonic Neoplasms; Diverticulum; Diverticular Diseases; Diverticulosis, Colonic; Nefopam

Study Results

No Results Posted as of Aug 8, 2018