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Clinical Trials/NCT03619538
NCT03619538CompletedNot Applicable

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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country80 target enrollmentStarted: June 1, 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Estimate morphine consumption
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

control group

Placebo Comparator

Intervention: saline solution (Other)

Nefopam group

Experimental

Intervention: Nefopam (Drug)

Outcomes

Primary Outcomes

Estimate morphine consumption

Time Frame: over 48 hours

mg

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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