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Impact of Maxigesic on postoperative recovery as assessed by QoR-15K in gynecological laparoscopic surgery

Status Approved

First Submitted Date

2023/11/28
Registered Date

2024/01/05
Last Updated Date

2023/12/15

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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	KCT0009097
Unique Protocol ID	CNUH-2023-384
Public/Brief Title	Impact of Maxigesic on postoperative recovery as assessed by QoR-15K in gynecological laparoscopic surgery
Scientific Title	Impact of Maxigesic on postoperative recovery as assessed by QoR-15K in gynecological laparoscopic surgery
Acronym	IMPORT
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CNUH-2023-384
Approval Date	2023-11-28
Institutional Review Board Name	Chonnam national university hospital institutional review board
Institutional Review Board Address	42, Jebong-ro, Dong-gu, Gwangju
Institutional Review Board Telephone	062-220-5257
Data Monitoring Committee	No

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	bo-eun kim
Title	Resident
Telephone	+82-62-220-6893
Affiliation	Chonnam National University Hospital
Address	Chonnam National University Hospital, 42 Jebong-ro, Dong-gu, Gwangju 61469, Republic of Korea.
Contact Person for Public Queries
Name	bo-eun kim
Title	resident of departmnet of Anesthesiology
Telephone	+82-62-220-6893
Affiliation	Chonnam National University Hospital
Address	Chonnam National University Hospital, 42 Jebong-ro, Dong-gu, Gwangju 61469, Republic of Korea.
Contact Person for Updating Information
Name	bo-eun kim
Title	Resident
Telephone	+82-62-220-6893
Affiliation	Chonnam National University Hospital
Address	Chonnam National University Hospital, 42 Jebong-ro, Dong-gu, Gwangju 61469, Republic of 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	2023-12-20 Anticipated
Target Number of Participant	50
Primary Completion Date	2024-10-30 , Anticipated
Study Completion Date	2024-10-31 , Anticipated
Name of Study	Chonnam National University Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2023-12-20 ,

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	Chonnam National University Hospital
Organization Type	Medical Institute
Project ID	CNUH-2023-384

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chonnam National University Hospital
Organization Type	Medical Institute
2. Sponsor Organization
Organization Name	Chonnam National University Hospital Hwasun Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The use of opioids for pain control after surgery, especially in female patients undergoing laparoscopic gynecological procedures, can increase the incidence of postoperative nausea and vomiting. Recently, there has been growing concern among patients regarding the potential for dependence on opioids. Consequently, the field of anesthesiology and pain medicine has been actively researching the use of non-opioid analgesics to reduce the reliance on opioid pain medication. A new pain medication containing two active ingredients, referred to as "Maxigesic," has been developed and reported to have excellent efficacy. It is expected that this pain medication may help reduce the use of opioids. The aim of this study is to assess patient satisfaction during the recovery process when using the recently introduced "Maxigesic" pain medication. To achieve this, we will compare the subjective satisfaction during the recovery process between two groups of patients: those who received "Maxigesic" and those who did not, using the QoR-15K questionnaire. This clinical trial will be conducted in patients scheduled for general anesthesia and laparoscopic gynecological surgery. Data collection will take place from the day before surgery to two days after surgery, focusing on QoR-15K scores, postoperative nausea and vomiting, and pain assessment. The study will include patients who meet the inclusion criteria and have provided written consent to participate. Initially, on the day before surgery, patients' overall condition, preoperative test results, and suitability for participation in the clinical trial will be assessed during the pre-anesthetic visit. The QoR-15K questionnaire will also be administered. Among the patients who have given written consent, random allocation will be used to assign them to one of two groups: the Maxigesic usage group and the non-usage group.

Study Summary Information

Lay Summary

The use of opioids for pain control after surgery, especially in female patients undergoing laparoscopic gynecological procedures, can increase the incidence of postoperative nausea and vomiting. Recently, there has been growing concern among patients regarding the potential for dependence on opioids. Consequently, the field of anesthesiology and pain medicine has been actively researching the use of non-opioid analgesics to reduce the reliance on opioid pain medication.

A new pain medication containing two active ingredients, referred to as "Maxigesic," has been developed and reported to have excellent efficacy. It is expected that this pain medication may help reduce the use of opioids. The aim of this study is to assess patient satisfaction during the recovery process when using the recently introduced "Maxigesic" pain medication. To achieve this, we will compare the subjective satisfaction during the recovery process between two groups of patients: those who received "Maxigesic" and those who did not, using the QoR-15K questionnaire.

This clinical trial will be conducted in patients scheduled for general anesthesia and laparoscopic gynecological surgery. Data collection will take place from the day before surgery to two days after surgery, focusing on QoR-15K scores, postoperative nausea and vomiting, and pain assessment. The study will include patients who meet the inclusion criteria and have provided written consent to participate.

Initially, on the day before surgery, patients' overall condition, preoperative test results, and suitability for participation in the clinical trial will be assessed during the pre-anesthetic visit. The QoR-15K questionnaire will also be administered. Among the patients who have given written consent, random allocation will be used to assign them to one of two groups: the Maxigesic usage group and the non-usage group.

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	Others (Randomized, Double blind, clinical trial)
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	In the Maxigesic group, a single vial (100ml) of Maxigesic solution is administered intravenously over a period of 15 minutes starting 10 minutes after the initiation of surgery. The control group does not receive any medication.
Number of Arms	2
Arm 1	Arm Label Group Maxigesic
	Target Number of Participant 25
	Arm Type Experimental
	Arm Description In the Maxigesic group, a single vial (100ml) of Maxigesic solution is administered intravenously over a period of 15 minutes starting 10 minutes after the initiation of surgery. The control group does not receive any medication.
Arm 2	Arm Label Group Control
	Target Number of Participant 25
	Arm Type No intervention
	Arm Description In the control group, no medication is administered during surgery.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (N00-N99)Diseases of the genitourinary system (N80.0)Endometriosis of uterus Uterine myoma, Uterine adenomyosis, Cervical intraepithelial neoplasia, Endometrial hyperplasia, Pelvic and fallopian tube adhesions, Ovarian cysts or benign tumors, Infertility-related conditions, Uterine cancer, Ovarian cancer, Urinary incontinence, Uterine prolapse, Functional uterine bleeding
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 20Year~No Limit
	Description 1. Patients aged 20 years and above scheduled for gynecological surgery under general anesthesia using laparoscopy as a regular surgical procedure. 2. Patients with American Society of Anesthesiologists (ASA) physical status classification 1-3. 3. Patients who have voluntarily provided written consent to participate in this clinical research study.
Exclusion Criteria	Patients with severe blood disorders, severe liver dysfunction, severe kidney dysfunction, severe congestive heart failure, or severe hypertension. Patients with a history of hypersensitivity or allergic reactions, such as asthma, urticaria, or allergies, to aspirin or other NSAIDs. Patients with a history of bronchial asthma or its equivalent. Patients with a history of gastrointestinal ulcers, gastrointestinal bleeding, or their equivalents. Pregnant women. Patients with physical disabilities or illiteracy. Other patients deemed unsuitable by the researchers.
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	The total QoR-15K score at 1 day after surgery
Timepoint	After 1 day of surgery
Primary Outcome(s) 2
Outcome	The total QoR-15K score at 2 day after surgery
Timepoint	After 2 day of surgery
Secondary Outcome(s) 1
Outcome	The total amount of Fentanyl used during the first day after surgery
Timepoint	After 1 day of surgery
Secondary Outcome(s) 2
Outcome	The average NRS (Numeric Rating Scale) score during the first day after surgery
Timepoint	After 1 day of surgery
Secondary Outcome(s) 3
Outcome	The average PONV (Postoperative Nausea and Vomiting) score during the first day after surgery
Timepoint	After 1 day of surgery
Secondary Outcome(s) 4
Outcome	The total amount of Fentanyl used during the second day after surgery
Timepoint	After 2 day of surgery
Secondary Outcome(s) 5
Outcome	The average NRS (Numeric Rating Scale) score during the second day after surgery
Timepoint	After 2 day of surgery
Secondary Outcome(s) 6
Outcome	The average PONV (Postoperative Nausea and Vomiting) score during the second day after surgery
Timepoint	After 2 day of surgery
Secondary Outcome(s) 7
Outcome	The amount of remifentanil used during surgery
Timepoint	during surgery
Secondary Outcome(s) 8
Outcome	Post-anesthesia care unit admission time and total length of stay
Timepoint	During Post-anesthesia care unit admission & During the entire hospital stay

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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