Colonic NeoplasmsNEFOPAMNCT03619538
Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery
A study testing Nefopam and saline solution in people with Colonic Neoplasms and Diverticulosis, Colonic, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms, Diverticulosis, Colonic
- What is being tested?
- Nefopam and saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to 25 Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Colonic Neoplasms, Diverticulosis, Colonic
- Being tested
- Nefopam, saline solution
- Medical subject headings
- Colonic Neoplasms, Diverticulosis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NefopamDrug
The nefopam group received 120 mg nefopam (Acupan, Pharmbio, France) by continuous iv infusion over the study period (48h)
saline solutionOther
The Control group received 120 mg placebo infusion (saline solution) by continuous iv infusion over the study period (48h).
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Not described Receives: Other: saline solution |
| Nefopam group | Experimental | Not described Receives: Drug: Nefopam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate morphine consumption
mg
Measured: over 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study startJun 2007
- Primary completion25 Jun 2007
- Study completion25 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques RIPART, Dr, Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619538
- Sponsor's protocol ID
- PHRC-I/2003/JYL-01
- Acronym
- NEFOPAM
- Status last verified
- Aug 2018
- First submitted
- 25 Jul 2018
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cuvillon P, Zoric L, Demattei C, Alonso S, Casano F, L'hermite J, Ripart J, Lefrant JY, Muller L. Opioid-sparing effect of nefopam in combination with paracetamol after major abdominal surgery: a randomized double-blind study. Minerva Anestesiol. 2017 Sep;83(9):914-920. doi: 10.23736/S0375-9393.17.11508-7. Epub 2017 Feb 13.
PubMed 28192892
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery
- ClinicalTrials.gov ID
- NCT03619538
- Acronym / sponsor ID
- NEFOPAM / PHRC-I/2003/JYL-01
- Conditions
- Colonic Neoplasms, Diverticulosis, Colonic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jun 2007 (actual)
- Primary completion
- 25 Jun 2007 (actual)
- Study completion
- 25 Jun 2007 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Other: saline solution |
| Nefopam group | Experimental | Drug: Nefopam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NefopamThe nefopam group received 120 mg nefopam (Acupan, Pharmbio, France) by continuous iv infusion over the study period (48h) | Drug | Nefopam group |
| saline solutionThe Control group received 120 mg placebo infusion (saline solution) by continuous iv infusion over the study period (48h). | Other | control group |
Primary outcome
Estimate morphine consumption
Time frame: over 48 hours
mg
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Results publication: PubMed 28192892Cuvillon P, Zoric L, Demattei C, Alonso S, Casano F, L'hermite J, Ripart J, Lefrant JY, Muller L. Opioid-sparing effect of nefopam in combination with paracetamol after major abdominal surgery: a randomized double-blind study. Minerva Anestesiol. 2017 Sep;83(9):914-920. doi: 10.23736/S0375-9393.17.11508-7. Epub 2017 Feb 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques RIPART, Dr principal investigator
Nîmes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nefopam and saline solution in people with Colonic Neoplasms and Diverticulosis, Colonic, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate morphine consumption (time frame: over 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03619538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.