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

Primary Purpose

Colonic Neoplasms, Diverticulosis, Colonic

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Nefopam

saline solution

About this trial

This is an interventional treatment trial for Colonic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control group

Nefopam group

Arm Description

Outcomes

Primary Outcome Measures

Estimate morphine consumption

Secondary Outcome Measures

Full Information

NCT ID

NCT03619538

First Posted

July 25, 2018

Last Updated

August 2, 2018

Sponsor

Centre Hospitalier Universitaire de Nīmes

1. Study Identification

Unique Protocol Identification Number

NCT03619538

Brief Title

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

Acronym

NEFOPAM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

July 2011 (Actual)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Neoplasms, Diverticulosis, Colonic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Placebo Comparator

Arm Title

Nefopam group

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nefopam

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

saline solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Estimate morphine consumption

Description

Time Frame

over 48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacques RIPART, Dr

Organizational Affiliation

Nîmes University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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