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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-06-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Colonic Neoplasms Diverticulosis, Colonic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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control group

Group Type PLACEBO_COMPARATOR

saline solution

Intervention Type OTHER

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

Nefopam group

Group Type EXPERIMENTAL

Nefopam

Intervention Type DRUG

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

Interventions

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Nefopam

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

Intervention Type DRUG

saline solution

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No