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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Diverticulosis, Colonic; Colonic Neoplasms

Treatments: Other: saline solution; Drug: Nefopam

Study type: Interventional

Funder types: Other

Identifiers

NCT03619538

PHRC-I/2003/JYL-01

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Treatment:

Other: saline solution

Nefopam group

Experimental group

Treatment:

Drug: Nefopam