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Dual (Maxigesic: acetaminophen／ibuprofen) versus triple (Maxigesic and nefopam) agent for postoperative analgesia in laparoscopic gastrectomy: a single-center, single-blind, randomized clinical trial

Status Approved

First Submitted Date

2023/11/17
Registered Date

2023/12/08
Last Updated Date

2024/01/31

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0009021
Unique Protocol ID	2023-08-018-003
Public/Brief Title	Comparison of 2 analgesic regimens for pain control after laparoscopic gastrectomy
Scientific Title	Dual (Maxigesic: acetaminophen／ibuprofen) versus triple (Maxigesic and nefopam) agent for postoperative analgesia in laparoscopic gastrectomy: a single-center, single-blind, randomized clinical trial
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted approval

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2023-08-018-003
Approval Date	2023-11-06
Institutional Review Board Name	Institutional Review Board of Chungnam National University Hospital
Institutional Review Board Address	282, Munhwa-ro, Jung-gu, Daejeon
Institutional Review Board Telephone	042-280-8715
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Chaeseong Lim
Title	Professor
Telephone	+82-42-280-7840
Affiliation	Chungnam National University Hospital
Address	282 Munhwa-ro, Jung-gu, Daejeon 35015, Korea.
Contact Person for Public Queries
Name	Chahyun Oh
Title	professor
Telephone	+82-42-280-7840
Affiliation	Chungnam National University Hospital
Address	282 Munhwa-ro, Jung-gu, Daejeon 35015, Korea.
Contact Person for Updating Information
Name	Chahyun Oh
Title	professor
Telephone	+82-42-280-7840
Affiliation	Chungnam National University Hospital
Address	282 Munhwa-ro, Jung-gu, Daejeon 35015, Korea.

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2024-03-01 Anticipated
Target Number of Participant	128
Primary Completion Date	2024-12-31 , Anticipated
Study Completion Date	2024-12-31 , Anticipated
Name of Study	Chungnam National University Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2024-03-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Kyongbo Parm
Organization Type	Pharmaceutical Company
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chungnam National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Postoperative pain, exacerbated by stress responses leading to increased insulin resistance, can delay recovery and reduce patient satisfaction. Various approaches have been introduced to manage postoperative pain, with the current standard involving multimodal therapy, including non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (AAP), in most surgical procedures. Such multimodal therapies effectively control pain by blocking various pain transmission pathways. Nefopam, identified as a non-narcotic and non-inflammatory analgesic acting centrally, has been reported in previous studies to reduce postoperative pain scores and decrease the consumption of narcotic analgesics. Due to its distinct mechanism of pain modulation compared to NSAIDs and AAP, there is a possibility of additional analgesic effects when combined with these two medications. Previous multicenter studies comparing the combination therapy of the three mentioned drugs were inconclusive, as they did not meet the targeted sample size and were prematurely terminated, failing to fully demonstrate the clinical benefits of this three-drug regimen. In this study, we aim to investigate whether a three-drug regimen, utilizing the combination of Maxigesic, a mixed formulation of NSAID and AAP, along with nefopam, can provide additional clinical benefits compared to a two-drug regimen (Maxigesic).

Study Summary Information

Lay Summary

Postoperative pain, exacerbated by stress responses leading to increased insulin resistance, can delay recovery and reduce patient satisfaction. Various approaches have been introduced to manage postoperative pain, with the current standard involving multimodal therapy, including non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (AAP), in most surgical procedures. Such multimodal therapies effectively control pain by blocking various pain transmission pathways.

Nefopam, identified as a non-narcotic and non-inflammatory analgesic acting centrally, has been reported in previous studies to reduce postoperative pain scores and decrease the consumption of narcotic analgesics. Due to its distinct mechanism of pain modulation compared to NSAIDs and AAP, there is a possibility of additional analgesic effects when combined with these two medications.

Previous multicenter studies comparing the combination therapy of the three mentioned drugs were inconclusive, as they did not meet the targeted sample size and were prematurely terminated, failing to fully demonstrate the clinical benefits of this three-drug regimen. In this study, we aim to investigate whether a three-drug regimen, utilizing the combination of Maxigesic, a mixed formulation of NSAID and AAP, along with nefopam, can provide additional clinical benefits compared to a two-drug regimen (Maxigesic).

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject, Caregiver, Outcome Accessor
Allocation	RCT
Intervention Type	Drug
Intervention Description	- Active comparator group (Maxigesic group, group M) Maxigesic 1 ampule (100 ml, 1st dose) & NSS 100 ml (placebo, blinded) administered simultaneously 15 minutes before surgery completion. Subsequent doses administered at 8-hour intervals over a total of 48 hours, for a total of 6 doses. - Study group (Maxigesic + nefopam group, group MN) Maxigesic 1 ampule (100 ml, 1st dose) & nefopam 20mg (mixed in NSS 100 ml, blinded) administered simultaneously 15 minutes before surgery completion. Subsequent doses administered at 8-hour intervals over a total of 48 hours, for a total of 6 doses.
Number of Arms	2
Arm 1	Arm Label Maxigesic group
	Target Number of Participant 64
	Arm Type Active comparator
	Arm Description Maxigesic 1 ampule (100 ml, 1st dose) & NSS 100 ml (placebo, blinded) administered simultaneously 15 minutes before surgery completion. Subsequent doses administered at 8-hour intervals over a total of 48 hours, for a total of 6 doses.
Arm 2	Arm Label Maxigesic + nefopam group
	Target Number of Participant 64
	Arm Type Experimental
	Arm Description Maxigesic 1 ampule (100 ml, 1st dose) & nefopam 20mg (mixed in NSS 100 ml, blinded) administered simultaneously 15 minutes before surgery completion. Subsequent doses administered at 8-hour intervals over a total of 48 hours, for a total of 6 doses.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K31.8)Other specified diseases of stomach and duodenum Gastrectomy
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~80Year
	Description 1. Elective laparoscopic gastrectomy 2. American Society of Anesthesiologists Physical Status Classification 1-3 3. Age range: 20-80 years 4. BMI (Body Mass Index) range: 18.5-35 kg/m2 5. Patients scheduled for the use of patient-controlled analgesia device
Exclusion Criteria	1. Wedge resection 2. Previous non-minor abdominal surgeries (examples of minor surgery: appendectomy, cholecystectomy, hernia repair, etc.) 3. Combined surgery 4. Known allergy or asthma reaction to the study drugs 5. Regular use of narcotic analgesics for more than 3 months before surgery 6. Concurrent use or requirement of analgesics due to ongoing pain 7. Impaired renal function (eGFR < 30 mL/min/1.73 m2) 8. Impaired liver function (cirrhosis, acute hepatitis, preoperative AST or ALT levels greater than 100 [more than twice the normal range]) 9. Pregnancy or breastfeeding 10. Active peptic ulcer disease 11. Closed-angle glaucoma 12. In cases of cognitive impairment and communication limitations making patient-controlled analgesia (PCA) use and pain assessment difficult 13. If planned postoperative pain control does not align with this study (e.g., if a different pain control method such as nerve block is planned)
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Opioid consumption during postoperative 48 hours
Timepoint	postoperative 48 hour
Secondary Outcome(s) 1
Outcome	Opioid consumption during postoperative 24 hours
Timepoint	postoperative 24 hour
Secondary Outcome(s) 2
Outcome	Immediate postoperative pain (NRS, post-anesthesia care unit)
Timepoint	Immediate postoperative during post-anesthesia care unit stay
Secondary Outcome(s) 3
Outcome	postoperative day 1 morning pain (maximum/ minimum NRS)
Timepoint	postoperative day 1 morning
Secondary Outcome(s) 4
Outcome	postoperative day 2 morning pain (maximum/ minimum NRS)
Timepoint	postoperative day 2 morning
Secondary Outcome(s) 5
Outcome	postoperative day 1 QOR 15
Timepoint	postoperative day 1
Secondary Outcome(s) 6
Outcome	postoperative day 2 QOR 15
Timepoint	postoperative day 2
Secondary Outcome(s) 7
Outcome	use of rescue antiemetics
Timepoint	during postoperative 48 hours
Secondary Outcome(s) 8
Outcome	use of rescue analgesics
Timepoint	during postoperative 48 hours

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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