Nonopioid Analgesics and Cholecystectomy
Primary Purpose
Cholecystectomy, Pain, Postoperative, Opioid Use
Status
Completed
Phase
Phase 3
Locations
Lebanon
Study Type
Interventional
Intervention
nefopam, ketoprofen, paracetamol
saline infusion, ketoprofen, paracetamol
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystectomy
Eligibility Criteria
Inclusion Criteria:
- ASA physical status I-II
- Age between 18 and 64 years
- Patients able to give consent
Exclusion Criteria:
- 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
- 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)
Sites / Locations
- American University of Beirut Medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo group
Multimodal group
Arm Description
Patients received sevoflurane-dexmedetomidine-based anesthesia with saline, ketoprofen and paracetamol for postoperative pain control,
patients received sevoflurane-dexmedetomidine-based anesthesia with nefopam, ketoprofen, and paracetamol for postoperative pain control.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Total fentanyl
Total fentanyl given intraoperatively.
Total morphine
Total morphine on the floor
Ketoprofen consumption
Ketoprofen consumption on the floor
Paracetamol consumption
Paracetamol consumption on the floor
Total morphine consumption at 24 hours after surgery
Total morphine doses consumed at 24 hours after surgery
Number of patients receiving morphine in PACU
Number of patients receiving morphine in post anesthesia care unit
Number of patients receiving morphine on the floor
Number of patients receiving morphine 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
Number of patients receiving ketoprofen on the floor
Number of patients receiving ketoprofen on the floor
Number of patients receiving paracetamol on the floor
Number of patients receiving paracetamol on the floor
NRS pain scores at rest in PACU
NRS pain scores at rest in post anesthesia care unit
NRS pain scores at 24 h after surgery
NRS pain scores at 24 hours after surgery
sedation scores in PACU
sedation scores in post anesthesia care unit
Time to first morphine requirement
Time to first morphine requirement
Time to discharge (readiness) from PACU
Time to discharge (readiness) from post anesthesia care unit
Nausea and vomiting
Incidence and severity of nausea and vomiting
Rescue antiemetics
Need for rescue antiemetics
Pruritus
Incidence of pruritus
Respiratory depression
Incidence of respiratory depression
Urinary retention
Incidence of urinary retention
Tachycardia
Episodes of tachycardia
Sweating
Episodes of sweating
Quality of recovery
Quality of recovery at 24 h using the QoR-40
Overall satisfaction score
Overall satisfaction score collected one month after surgery.
Full Information
NCT ID
NCT04622813
First Posted
October 30, 2020
Last Updated
May 3, 2023
Sponsor
American University of Beirut Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04622813
Brief Title
Nonopioid Analgesics and Cholecystectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
October 19, 2022 (Actual)
Study Completion Date
October 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystectomy, Pain, Postoperative, Opioid Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients received sevoflurane-dexmedetomidine-based anesthesia with saline, ketoprofen and paracetamol for postoperative pain control,
Arm Title
Multimodal group
Arm Type
Experimental
Arm Description
patients received sevoflurane-dexmedetomidine-based anesthesia with nefopam, ketoprofen, and paracetamol for postoperative pain control.
Intervention Type
Drug
Intervention Name(s)
nefopam, ketoprofen, paracetamol
Intervention Description
Patients in this group will receive Nefopam and Ketoprofen in addition to the paracetamol intraoperatively prior to the anticipated end of the surgery
Intervention Type
Drug
Intervention Name(s)
saline infusion, ketoprofen, paracetamol
Intervention Description
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
Primary Outcome Measure Information:
Title
Total morphine consumption in the post anesthesia care unit
Description
Total morphine doses consumed after the surgery during the post anesthesia care unit stay of the patient
Time Frame
Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Secondary Outcome Measure Information:
Title
Total fentanyl
Description
Total fentanyl given intraoperatively.
Time Frame
Intraoperatively
Title
Total morphine
Description
Total morphine on the floor
Time Frame
Throughout the patient's stay on the floor
Title
Ketoprofen consumption
Description
Ketoprofen consumption on the floor
Time Frame
Throughout the patient's stay on the floor
Title
Paracetamol consumption
Description
Paracetamol consumption on the floor
Time Frame
Throughout the patient's stay on the floor
Title
Total morphine consumption at 24 hours after surgery
Description
Total morphine doses consumed at 24 hours after surgery
Time Frame
24 hours after surgery
Title
Number of patients receiving morphine in PACU
Description
Number of patients receiving morphine in post anesthesia care unit
Time Frame
Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Title
Number of patients receiving morphine on the floor
Description
Number of patients receiving morphine on the floor
Time Frame
Throughout the patient's stay on the floor
Title
Number of patients receiving morphine during the first 24 hours after surgery
Description
Number of patients receiving morphine during the first 24 hours after surgery
Time Frame
During the first 24 hours after surgery
Title
Number of patients receiving ketoprofen on the floor
Description
Number of patients receiving ketoprofen on the floor
Time Frame
On the floor
Title
Number of patients receiving paracetamol on the floor
Description
Number of patients receiving paracetamol on the floor
Time Frame
On the floor
Title
NRS pain scores at rest in PACU
Description
NRS pain scores at rest in post anesthesia care unit
Time Frame
Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Title
NRS pain scores at 24 h after surgery
Description
NRS pain scores at 24 hours after surgery
Time Frame
24 hours after surgery
Title
sedation scores in PACU
Description
sedation scores in post anesthesia care unit
Time Frame
Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Title
Time to first morphine requirement
Description
Time to first morphine requirement
Time Frame
From the time of arrival to PACU until discharge
Title
Time to discharge (readiness) from PACU
Description
Time to discharge (readiness) from post anesthesia care unit
Time Frame
Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Title
Nausea and vomiting
Description
Incidence and severity of nausea and vomiting
Time Frame
Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Title
Rescue antiemetics
Description
Need for rescue antiemetics
Time Frame
Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Title
Pruritus
Description
Incidence of pruritus
Time Frame
Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Title
Respiratory depression
Description
Incidence of respiratory depression
Time Frame
Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Title
Urinary retention
Description
Incidence of urinary retention
Time Frame
Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)
Title
Tachycardia
Description
Episodes of tachycardia
Time Frame
Intraoperatively and in PACU
Title
Sweating
Description
Episodes of sweating
Time Frame
Intraoperatively and in PACU
Title
Quality of recovery
Description
Quality of recovery at 24 h using the QoR-40
Time Frame
At 24 hours after the surgery
Title
Overall satisfaction score
Description
Overall satisfaction score collected one month after surgery.
Time Frame
One month after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA physical status I-II
Age between 18 and 64 years
Patients able to give consent
Exclusion Criteria:
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar Sayyid, MD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut Medical center
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nonopioid Analgesics and Cholecystectomy
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