Renal TumorNCT01833728
A Comparison of Nefopam-propacetamol Combination and Propacetamol for Postoperative Quality of Recovery After Laparoscopic Nephrectomy
A study testing nefopam-propacetamol combination and propacetamol alone in people with Renal Tumor, run by Yonsei University at 1 site in South Korea.
Trial summary
The multimodal analgesia for postoperative pain aims for optimal analgesia through additive or synergic drug effects. The multimodal analgesia results in the use of smaller doses of opioids and lowering opioid-related side effects. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Renal Tumor
- What is being tested?
- nefopam-propacetamol combination and propacetamol alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Jan 2014
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status 1-3,
- aged 20 to 65 years,
- undergoing laparoscopic nephrectomy
Who cannot join
- Severe cardiac disease,
- hepatic insufficiency,
- chronic kidney disease stage ≥3,
- preoperative use of analgesics(corticosteroids, opioid),
- chronic alcoholics,
- hemolytic anemia,
- convulsions
Trial locations and contacts
1 site in 1 country.
About this study
The multimodal analgesia for postoperative pain aims for optimal analgesia through additive or synergic drug effects. The multimodal analgesia results in the use of smaller doses of opioids and lowering opioid-related side effects.
Non-opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), propacetamol (prodrug of acetaminophen), nefopam are often given along with opioids as part of multimodal analgesia after major surgery.
Read more
NSAIDS, commonly used non-opioid analgesics, have gastro-intestinal, renal, and cardiac side effects.
In contrast, propacetamol or nefopam, two drugs with central analgesic effects, can be safely used as analgesic adjuvants with opioid after nephrectomy, because these drugs do not alter renal function or cause hemorrhagic complications.
Recent study demonstrated that the antinociceptive properties of paracetamol (intravenous acetaminophen) associated with the analgesic effectiveness of nefopam could explain the observed synergy of the combination.
The aim of this randomized, double-blinded study is to compare the opioid-sparing effect and analgesic efficacy, as well as quality of recovery, of nefopam-propacetamol combination and propacetamol in patients undergoing laparoscopic nephrectomy.
- Conditions
- Renal Tumor
- Being tested
- nefopam-propacetamol combination, propacetamol alone
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nefopam-propacetamol combinationDrug
Patients in both groups will receive intravenous patient-controlled analgesia (PCA) using fentanyl.
In nefopam-propacetamol combination group, patients will receive nefopam(20mg mixed to normal saline 100mL) and propacetamol(2g mixed to normal saline 100mL), 30 minutes before the end of operation, every 6 hours for up to 48 hours.
propacetamol aloneDrug
In propacetamol alone group, patients will receive placebo (normal saline 2 ml mixed to normal saline 100mL) and propacetamol(2g mixed to normal saline 100mL), 30 minutes before the end of operation, every 6 hours for up to 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| nefopam-propacetamol combination group | Experimental | Not described Receives: Drug: nefopam-propacetamol combination |
| propacetamol alone group | Active comparator | Not described Receives: Drug: propacetamol alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
Quality of recovery questionnaire score at 24 hours after surgery
Measured: at 24 hours postoperative
Secondary outcomes (1)
Postoperative opioid consumption
Measured: at 24 and at 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal TumorStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833728
- Sponsor's protocol ID
- 4-2013-0023
- Status last verified
- Feb 2014
- First submitted
- 14 Apr 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mimoz O, Incagnoli P, Josse C, Gillon MC, Kuhlman L, Mirand A, Soilleux H, Fletcher D. Analgesic efficacy and safety of nefopam vs. propacetamol following hepatic resection. Anaesthesia. 2001 Jun;56(6):520-5. doi: 10.1046/j.1365-2044.2001.01980.x.
PubMed 11412156Girard P, Niedergang B, Pansart Y, Coppe MC, Verleye M. Systematic evaluation of the nefopam-paracetamol combination in rodent models of antinociception. Clin Exp Pharmacol Physiol. 2011 Mar;38(3):170-8. doi: 10.1111/j.1440-1681.2011.05477.x.
PubMed 21226753
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Nefopam-propacetamol Combination and Propacetamol for Postoperative Quality of Recovery After Laparoscopic Nephrectomy
- ClinicalTrials.gov ID
- NCT01833728
- Acronym / sponsor ID
- 4-2013-0023
- Conditions
- Renal Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Apr 2013 (estimated)
- 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.
The multimodal analgesia for postoperative pain aims for optimal analgesia through additive or synergic drug effects. The multimodal analgesia results in the use of smaller doses of opioids and lowering opioid-related side effects.
Non-opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), propacetamol (prodrug of acetaminophen), nefopam are often given along with opioids as part of multimodal analgesia after major surgery.
NSAIDS, commonly used non-opioid analgesics, have gastro-intestinal, renal, and cardiac side effects.
In contrast, propacetamol or nefopam, two drugs with central analgesic effects, can be safely used as analgesic adjuvants with opioid after nephrectomy, because these drugs do not alter renal function or cause hemorrhagic complications.
Recent study demonstrated that the antinociceptive properties of paracetamol (intravenous acetaminophen) associated with the analgesic effectiveness of nefopam could explain the observed synergy of the combination.
The aim of this randomized, double-blinded study is to compare the opioid-sparing effect and analgesic efficacy, as well as quality of recovery, of nefopam-propacetamol combination and propacetamol in patients undergoing laparoscopic nephrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nefopam-propacetamol combination group | Experimental | Drug: nefopam-propacetamol combination |
| propacetamol alone group | Active comparator | Drug: propacetamol alone |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA status 1-3,
- aged 20 to 65 years,
- undergoing laparoscopic nephrectomy
Key exclusion criteria (7 listed)
- Severe cardiac disease,
- hepatic insufficiency,
- chronic kidney disease stage ≥3,
- preoperative use of analgesics(corticosteroids, opioid),
- chronic alcoholics,
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 |
|---|---|---|
| nefopam-propacetamol combinationPatients in both groups will receive intravenous patient-controlled analgesia (PCA) using fentanyl. In nefopam-propacetamol combination group, patients will receive nefopam(20mg mixed to normal saline 100mL) and propacetamol(2g mixed to normal saline 100mL), 30 minutes before the end of operation, every 6 hours for up to 48 hours. | Drug | nefopam-propacetamol combination group |
| propacetamol aloneIn propacetamol alone group, patients will receive placebo (normal saline 2 ml mixed to normal saline 100mL) and propacetamol(2g mixed to normal saline 100mL), 30 minutes before the end of operation, every 6 hours for up to 48 hours. | Drug | propacetamol alone group |
Primary outcome
Quality of Recovery
Time frame: at 24 hours postoperative
Quality of recovery questionnaire score at 24 hours after surgery
1 secondary outcome
Postoperative opioid consumption
Time frame: at 24 and at 48 hours after surgery
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 19 Feb 2014.
- Background: PubMed 11412156Mimoz O, Incagnoli P, Josse C, Gillon MC, Kuhlman L, Mirand A, Soilleux H, Fletcher D. Analgesic efficacy and safety of nefopam vs. propacetamol following hepatic resection. Anaesthesia. 2001 Jun;56(6):520-5. doi: 10.1046/j.1365-2044.2001.01980.x.
- Background: PubMed 21226753Girard P, Niedergang B, Pansart Y, Coppe MC, Verleye M. Systematic evaluation of the nefopam-paracetamol combination in rodent models of antinociception. Clin Exp Pharmacol Physiol. 2011 Mar;38(3):170-8. doi: 10.1111/j.1440-1681.2011.05477.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-propacetamol combination and propacetamol alone in people with Renal Tumor, run by Yonsei University at 1 site in South Korea.
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 7 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 19 Feb 2014. 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 South Korea. 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. 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?
Quality of Recovery (time frame: at 24 hours postoperative). 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 NCT01833728, which also lists 2 linked publications.
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 19 Feb 2014.