CholecystectomyPhase 3NCT04622813
Nonopioid Analgesics and Cholecystectomy
A Phase 3 study testing nefopam, ketoprofen, paracetamol and saline infusion, ketoprofen, paracetamol in people with Cholecystectomy and Pain, Postoperative, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The goal of this clinical trial is to evaluate the effect of the addition of nefopam to a multimodal analgesic regimen consisting of ketoprofen and paracetamol during sevoflurane- dexmedetomidine-based anesthesia on postoperative morphine requirements in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Cholecystectomy, Pain, Postoperative, Opioid Use
- What is being tested?
- nefopam, ketoprofen, paracetamol and saline infusion, ketoprofen, paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteLebanon
- Study dates
- 8 Apr 2021to 19 Oct 2022
- Phase
- Phase 3
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I-II
- Age between 18 and 64 years
- Patients able to give consent
Who cannot join
- ASA physical status III to V
- History of chronic pain
- Use of an opioid analgesic within 12 hours prior to surgery
- Alcohol or drug abuse
- Chronic opioid intake
- Morbid obesity
Show all 10Show fewer
- Psychiatric disorder
- Pregnancy or breast-feeding
- Intolerance to NSAIDSs
- Allergy or contraindication to nefopam (acute angle-closure glaucoma, epilepsy, coronary artery disease, prostate adenoma), to morphine or paracetamol (liver failure), to ketoprofen (increased risk of bleeding, stomach or intestinal ulcer, chronic kidney disease) or to dexmedetomidine (uncontrolled hypertension, heart block greater than first degree, or other clinically significant morbidities)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intraoperative Nefopam, Ketoprofen and Paracetamol Combination vs Ketoprofen and Paracetamol Combination on Postoperative Morphine Requirements After Laparoscopic Cholecystectomy: A Randomized, Controlled Trial
The goal of this clinical trial is to evaluate the effect of the addition of nefopam to a multimodal analgesic regimen consisting of ketoprofen and paracetamol during sevoflurane- dexmedetomidine-based anesthesia on postoperative morphine requirements in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Nefopam is a centrally-acting anti-nociceptive compound with supraspinal and spinal sites of action. It inhibits monoamine reuptake, modulates descending serotoninergic pain, and may also interact with a dopaminergic pathway. Because its mechanism of action is distinct from that of other analgesic opioids, nefopam may well have a role in analgesic protocols. The role of nefopam in multimodal analgesia has been extensively investigated in laparoscopic cholecystectomy. However, there is general agreement that more studies are needed to determine the ideal multimodal strategy. No previous study has investigated a combination regimen of the three most commonly prescribed non-opioid analgesics (NOA) (nefopam, ketoprofen, and paracetamol) vs ketoprofen and paracetamol combination during sevoflurane-dexmedetomidine based anesthesia on pain control after laparoscopic cholecystectomy.
The aim of our study is to compare a combination regimen of three NOA (nefopam, ketoprofen, and paracetamol) vs ketoprofen and paracetamol combination during sevoflurane-dexmedetomidine based anesthesia on pain control after laparoscopic cholecystectomy. We will try to demonstrate the benefit with the addition of a third NOA, which is the nefopam, to the double-drug regimen including ketoprofen and paracetamol. Our hypothesis is that this combination regimen of three NOA is associated with less postoperative pain, less opioid consumption, shorter length of post-anesthesia care unit (PACU) stay, and fewer opioid-related adverse effects and postoperative complications compared to the double-drug regimen of ketoprofen and paracetamol.
In this prospective randomized double-blind study, 90 patients aged 18 to 64 years, with American Society of Anesthesiologists (ASA) physical status I and II, will be randomly assigned using a computer-generated random number table to one of two treatment groups. Group A will receive sevoflurane-dexmedetomidine based anesthesia with ketoprofen and paracetamol for postoperative pain control, and group B will receive sevoflurane-dexmedetomidine based anesthesia with nefopam, ketoprofen, and paracetamol for postoperative pain control. The primary outcome measure of this study is total morphine consumption in PACU. Normally distributed data will be summarized as mean ± SD and non-normally distributed data will be summarized as median [interquartile range]. This study would have an impact on our current practice and may help find out the best multimodal analgesic strategy to control postoperative pain after laparoscopic cholecystectomy.
- Conditions
- Cholecystectomy, Pain, Postoperative, Opioid Use
- Being tested
- nefopam, ketoprofen, paracetamol, saline infusion, ketoprofen, paracetamol
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nefopam, ketoprofen, paracetamolDrug
Patients in this group will receive Nefopam and Ketoprofen in addition to the paracetamol intraoperatively prior to the anticipated end of the surgery
saline infusion, ketoprofen, paracetamolDrug
Patients in this group will receive one placebo infusion (saline infusion) in addition to the ketoprofen and paracetamol intraoperatively prior to the anticipated end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Patients received sevoflurane-dexmedetomidine-based anesthesia with saline, ketoprofen and paracetamol for postoperative pain control, Receives: Drug: saline infusion, ketoprofen, paracetamol |
| Multimodal group | Experimental | patients received sevoflurane-dexmedetomidine-based anesthesia with nefopam, ketoprofen, and paracetamol for postoperative pain control. Receives: Drug: nefopam, ketoprofen, paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption in the post anesthesia care unit
Total morphine doses consumed after the surgery during the post anesthesia care unit stay of the patient
Measured: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Secondary outcomes (24)
Total fentanyl
Total fentanyl given intraoperatively.
Measured: Intraoperatively
Total morphine
Total morphine on the floor
Measured: Throughout the patient's stay on the floor
Ketoprofen consumption
Ketoprofen consumption on the floor
Measured: Throughout the patient's stay on the floor
Paracetamol consumption
Paracetamol consumption on the floor
Measured: Throughout the patient's stay on the floor
Total morphine consumption at 24 hours after surgery
Total morphine doses consumed at 24 hours after surgery
Measured: 24 hours after surgery
Number of patients receiving morphine in PACU
Number of patients receiving morphine in post anesthesia care unit
Measured: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Number of patients receiving morphine on the floor
Number of patients receiving morphine on the floor
Measured: Throughout the patient's stay on the floor
Number of patients receiving morphine during the first 24 hours after surgery
Number of patients receiving morphine during the first 24 hours after surgery
Measured: During the first 24 hours after surgery
Number of patients receiving ketoprofen on the floor
Number of patients receiving ketoprofen on the floor
Measured: On the floor
Number of patients receiving paracetamol on the floor
Number of patients receiving paracetamol on the floor
Measured: On the floor
NRS pain scores at rest in PACU
NRS pain scores at rest in post anesthesia care unit
Measured: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
NRS pain scores at 24 h after surgery
NRS pain scores at 24 hours after surgery
Measured: 24 hours after surgery
sedation scores in PACU
sedation scores in post anesthesia care unit
Measured: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Time to first morphine requirement
Time to first morphine requirement
Measured: From the time of arrival to PACU until discharge
Time to discharge (readiness) from PACU
Time to discharge (readiness) from post anesthesia care unit
Measured: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Nausea and vomiting
Incidence and severity of nausea and vomiting
Measured: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Rescue antiemetics
Need for rescue antiemetics
Measured: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Pruritus
Incidence of pruritus
Measured: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Respiratory depression
Incidence of respiratory depression
Measured: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Urinary retention
Incidence of urinary retention
Measured: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Tachycardia
Episodes of tachycardia
Measured: Intraoperatively and in PACU
Sweating
Episodes of sweating
Measured: Intraoperatively and in PACU
Quality of recovery
Quality of recovery at 24 h using the QoR-40
Measured: At 24 hours after the surgery
Overall satisfaction score
Overall satisfaction score collected one month after surgery.
Measured: One month after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start8 Apr 2021
- Primary completion19 Oct 2022
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystectomyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Sayyid, American University of Beirut Medical Center
- Investigators
- Sahar Sayyid, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622813
- Sponsor's protocol ID
- BIO-2020-0375
- Status last verified
- May 2023
- First submitted
- 30 Oct 2020
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Nefopam, Ketoprofen and Paracetamol Combination vs Ketoprofen and Paracetamol Combination on Postoperative Morphine Requirements After Laparoscopic Cholecystectomy: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04622813
- Acronym / sponsor ID
- BIO-2020-0375
- Conditions
- Cholecystectomy, Pain, Postoperative, Opioid Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 10 Nov 2020 (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.
The goal of this clinical trial is to evaluate the effect of the addition of nefopam to a multimodal analgesic regimen consisting of ketoprofen and paracetamol during sevoflurane- dexmedetomidine-based anesthesia on postoperative morphine requirements in patients undergoing laparoscopic cholecystectomy.
Detailed description
Nefopam is a centrally-acting anti-nociceptive compound with supraspinal and spinal sites of action. It inhibits monoamine reuptake, modulates descending serotoninergic pain, and may also interact with a dopaminergic pathway. Because its mechanism of action is distinct from that of other analgesic opioids, nefopam may well have a role in analgesic protocols. The role of nefopam in multimodal analgesia has been extensively investigated in laparoscopic cholecystectomy. However, there is general agreement that more studies are needed to determine the ideal multimodal strategy. No previous study has investigated a combination regimen of the three most commonly prescribed non-opioid analgesics (NOA) (nefopam, ketoprofen, and paracetamol) vs ketoprofen and paracetamol combination during sevoflurane-dexmedetomidine based anesthesia on pain control after laparoscopic cholecystectomy.
The aim of our study is to compare a combination regimen of three NOA (nefopam, ketoprofen, and paracetamol) vs ketoprofen and paracetamol combination during sevoflurane-dexmedetomidine based anesthesia on pain control after laparoscopic cholecystectomy. We will try to demonstrate the benefit with the addition of a third NOA, which is the nefopam, to the double-drug regimen including ketoprofen and paracetamol. Our hypothesis is that this combination regimen of three NOA is associated with less postoperative pain, less opioid consumption, shorter length of post-anesthesia care unit (PACU) stay, and fewer opioid-related adverse effects and postoperative complications compared to the double-drug regimen of ketoprofen and paracetamol.
In this prospective randomized double-blind study, 90 patients aged 18 to 64 years, with American Society of Anesthesiologists (ASA) physical status I and II, will be randomly assigned using a computer-generated random number table to one of two treatment groups. Group A will receive sevoflurane-dexmedetomidine based anesthesia with ketoprofen and paracetamol for postoperative pain control, and group B will receive sevoflurane-dexmedetomidine based anesthesia with nefopam, ketoprofen, and paracetamol for postoperative pain control. The primary outcome measure of this study is total morphine consumption in PACU. Normally distributed data will be summarized as mean ± SD and non-normally distributed data will be summarized as median [interquartile range]. This study would have an impact on our current practice and may help find out the best multimodal analgesic strategy to control postoperative pain after laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: saline infusion, ketoprofen, paracetamolPatients received sevoflurane-dexmedetomidine-based anesthesia with saline, ketoprofen and paracetamol for postoperative pain control, |
| Multimodal group | Experimental | Drug: nefopam, ketoprofen, paracetamolpatients received sevoflurane-dexmedetomidine-based anesthesia with nefopam, ketoprofen, and paracetamol for postoperative pain control. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status I-II
- Age between 18 and 64 years
- Patients able to give consent
Key exclusion criteria (10 listed)
- ASA physical status III to V
- History of chronic pain
- Use of an opioid analgesic within 12 hours prior to surgery
- Alcohol or drug abuse
- Chronic opioid intake
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, ketoprofen, paracetamolPatients in this group will receive Nefopam and Ketoprofen in addition to the paracetamol intraoperatively prior to the anticipated end of the surgery | Drug | Multimodal group |
| saline infusion, ketoprofen, paracetamolPatients in this group will receive one placebo infusion (saline infusion) in addition to the ketoprofen and paracetamol intraoperatively prior to the anticipated end of the surgery | Drug | Placebo group |
Primary outcome
Total morphine consumption in the post anesthesia care unit
Time frame: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Total morphine doses consumed after the surgery during the post anesthesia care unit stay of the patient
24 secondary outcomes
Total fentanyl
Time frame: Intraoperatively
Total morphine
Time frame: Throughout the patient's stay on the floor
Ketoprofen consumption
Time frame: Throughout the patient's stay on the floor
Paracetamol consumption
Time frame: Throughout the patient's stay on the floor
Total morphine consumption at 24 hours after surgery
Time frame: 24 hours after surgery
Number of patients receiving morphine in PACU
Time frame: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Number of patients receiving morphine on the floor
Time frame: Throughout the patient's stay on the floor
Number of patients receiving morphine during the first 24 hours after surgery
Time frame: During the first 24 hours after surgery
Number of patients receiving ketoprofen on the floor
Time frame: On the floor
Number of patients receiving paracetamol on the floor
Time frame: On the floor
NRS pain scores at rest in PACU
Time frame: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
NRS pain scores at 24 h after surgery
Time frame: 24 hours after surgery
sedation scores in PACU
Time frame: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Time to first morphine requirement
Time frame: From the time of arrival to PACU until discharge
Time to discharge (readiness) from PACU
Time frame: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Nausea and vomiting
Time frame: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Rescue antiemetics
Time frame: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Pruritus
Time frame: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Respiratory depression
Time frame: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Urinary retention
Time frame: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Tachycardia
Time frame: Intraoperatively and in PACU
Sweating
Time frame: Intraoperatively and in PACU
Quality of recovery
Time frame: At 24 hours after the surgery
Overall satisfaction score
Time frame: One month 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 6 May 2023.
- Individual participant dataSharing planned: No
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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.
Sahar Sayyid, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nefopam, ketoprofen, paracetamol and saline infusion, ketoprofen, paracetamol in people with Cholecystectomy and Pain, Postoperative, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 10 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 6 May 2023. 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 Lebanon. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total morphine consumption in the post anesthesia care unit (time frame: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.