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

Colonic Neoplasms Clinical Trial

— NEFOPAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619538
• Other study ID #: PHRC-I/2003/JYL-01
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Diverticulosis, Colonic
• Diverticulum

Intervention

Drug:
• Nefopam
The nefopam group received 120 mg nefopam (Acupan, Pharmbio, France) by continuous iv infusion over the study period (48h)

Other:
• saline solution
The Control group received 120 mg placebo infusion (saline solution) by continuous iv infusion over the study period (48h).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate morphine consumption	mg	over 48 hours