search
Back to results

Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
acetaminophen/ibuprofen fixed-dose combination
Saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative Pain

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled to undergo elective unilateral VATS segmentectomy or lobectomy under general anesthesia
  • American Society of Anesthesiologists (ASA)physical classification I-II
  • Consent to IV-patient controlled analgesia use
  • Willingness and ability to sign an informed consent document

Exclusion Criteria:

  • Do not understand our study
  • Allergies to anesthetic or analgesic medications
  • Continuous local anesthetics infiltration for postoperative pain control
  • Patients who receive mechanical ventilation more than 2 hours after surgery
  • Pregnancy/Breastfeeder
  • Medical or psychological disease that can affect thetreatment response

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Maxigesic group

Control group

Arm Description

At the end of induction, the Maxigesic group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 min, every 6 hours, a total of 4 times.

At the end of induction, the control group will receive intravenous normal saline with the same volume and same time points as the intervention group receives.

Outcomes

Primary Outcome Measures

Total fentanyl consumption during 24 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Secondary Outcome Measures

Total fentanyl consumption
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Postoperative pain score
11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (%)
Quality of recovery-15
Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"

Full Information

First Posted
May 4, 2022
Last Updated
August 20, 2023
Sponsor
Seoul National University Hospital
Collaborators
Kyongbo Pharmaceutical
search

1. Study Identification

Unique Protocol Identification Number
NCT05366777
Brief Title
Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption
Official Title
Effect of an Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption and Pain After Video-assisted Thoracic Surgery: A Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
July 14, 2023 (Actual)
Study Completion Date
October 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Kyongbo Pharmaceutical

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
This prospective, randomized, double-blinded study is designed to evaluate the postoperative analgesic effect of the intravenous acetaminophen/ibuprofen fixed-dose combination in patients undergoing video-assisted thoracic surgery (VATS). We hypothesize that the intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce postoperative opioid consumption and pain severity in patients with VATS.
Detailed Description
Adult patients undergoing elective unilateral VATS wedge resection, segmentectomy, or lobectomy are randomly allocated to receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (n=48) or not (n=48). At the end of induction, the intervention group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 min, every 6 hours, a total of 4 times. The control group will receive intravenous normal saline with the same volume and same time points as the intervention group receives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective randomized double-blinded study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The nurse who is not involved in this study knows the allocated group and sends the bottle of the drug which looks the same in both groups, to the operation room and ward. The care provider, investigator, patients, and outcomes assessor will be not informed of the infusion of the drug by not attaching an identifiable label so that it cannot be distinguished from normal saline.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maxigesic group
Arm Type
Experimental
Arm Description
At the end of induction, the Maxigesic group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 min, every 6 hours, a total of 4 times.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
At the end of induction, the control group will receive intravenous normal saline with the same volume and same time points as the intervention group receives.
Intervention Type
Drug
Intervention Name(s)
acetaminophen/ibuprofen fixed-dose combination
Other Intervention Name(s)
Maxigesic
Intervention Description
Intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (total 100 ml)
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Placebo
Intervention Description
100 ml of normal saline
Primary Outcome Measure Information:
Title
Total fentanyl consumption during 24 hours
Description
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Time Frame
postoperative 24 hours
Secondary Outcome Measure Information:
Title
Total fentanyl consumption
Description
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Time Frame
postoperative 6, 48 hours
Title
Postoperative pain score
Description
11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"
Time Frame
postoperative 6, 24, 48 hours
Title
Postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting (%)
Time Frame
postoperative 24, 48 hours
Title
Quality of recovery-15
Description
Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"
Time Frame
postoperative 24, 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled to undergo elective unilateral VATS segmentectomy or lobectomy under general anesthesia American Society of Anesthesiologists (ASA)physical classification I-II Consent to IV-patient controlled analgesia use Willingness and ability to sign an informed consent document Exclusion Criteria: Do not understand our study Allergies to anesthetic or analgesic medications Continuous local anesthetics infiltration for postoperative pain control Patients who receive mechanical ventilation more than 2 hours after surgery Pregnancy/Breastfeeder Medical or psychological disease that can affect thetreatment response
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hojin Lee, PhD
Phone
82-2-2072-2467
Email
zenerdiode03@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Susie Yoon, PhD
Phone
82-2-2072-2467
Email
susiey87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hojin Lee, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
KS013
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hojin Lee, MD, PhD
Phone
82-2-2072-2467
Email
zenerdiode03@gmail.com
First Name & Middle Initial & Last Name & Degree
Susie Yoon, MD, PhD
Phone
82-2-2072-2467
Email
susie87@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption

We'll reach out to this number within 24 hrs