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Preemptive and Preventive Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy

Primary Purpose

Postoperative Pain

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Acetaminophen/Ibuprofen fixed-dose combination

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)MaleDoes not accept healthy volunteers

Inclusion Criteria: Patients scheduled to undergo elective robot-assisted radical prostatectomy 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: Who do not understand or agree with our study American Society of Anesthesiologists (ASA) physical classification III-IV Chronic usage of opioid analgesics Moderate to severe pain with other cause before surgery Allergies to anesthetic or analgesic medications used in this study Anticipated blood loss larger than 2 liters Need for intensive care after surgery History of gastric ulcer or gastrointestinal bleeding History of liver failure, renal failure or heart failure Current alcoholism Taking anti-coagulation drugs or history of coagulation disease History of bronchial asthma Medical or psychological disease that can affect the treatment response Taking barbitutate or tricyclic antidepressant

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preemptive administration group

Preventive administration group

Arm Description

Preemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia.

The preventive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes when surgical site closure starts.

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 (PCA)

Postoperative pain score

11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"

Count of rescue analgesics administration

Number of count of rescue analgesics administered because of patient's request for additional analgesia than IV PCA

Opioid side effects

Incidence of opioid side effects like postoperative nausea/vomiting, hypotension, dizziness, somnolence and respiratory depression (%)

Quality of recovery-15

Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"

Full Information

NCT ID

NCT05685342

First Posted

January 5, 2023

Last Updated

August 20, 2023

Sponsor

Seoul National University Hospital

Collaborators

Kyongbo Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT05685342

Brief Title

Preemptive and Preventive Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy

Official Title

Comparison of the Opioid-sparing Effect of Preemptive and Preventive Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy: A Double-blind Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 27, 2023 (Actual)

Primary Completion Date

August 30, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This prospective, randomized, double-blinded study is designed to compare opioid-sparing effect of preemptive and preventive intravenous acetaminophen/ibuprofen fixed-dose combination in patients undergoing robot-assisted radical prostatectomy (RARP). We hypothesize that preemptive administration of intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce postoperative opioid consumption and pain severity than preventive administration in patients undergoing RARP.

Detailed Description

Adult patients undergoing elective robot-assisted radical prostatectomy are randomly allocated to receive preemptive administration of acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (n=77) or preventive administration (n=77). The preemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia. The preventive administration group will receive same dosage of drug for same duration when surgical site closure starts.

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

An investigator who is not involved in this study randomly allocates the group and another investigator who dose not evaluate clinical endpoints keeps the result of allocation in a sealed envelope. On the day of study, the second investigator opens the envelope to check allocation and sends a drug and normal saline in identical looking bottles with label only indicating the order of administration.

Allocation

Randomized

Enrollment

154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Preemptive administration group

Arm Type

Experimental

Arm Description

Preemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia.

Arm Title

Preventive administration group

Arm Type

Active Comparator

Arm Description

The preventive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes when surgical site closure starts.

Intervention Type

Drug

Intervention Name(s)

Acetaminophen/Ibuprofen fixed-dose combination

Other Intervention Name(s)

Maxigesic

Intervention Description

Intravenous administration of Acetaminophen (1000 mg)/Ibuprofen (300 mg) fixed-dose combination (total 100 ml)

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 (PCA)

Time Frame

Postoperative 2, 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 2 (resting only), 6, 24, 48 hours

Title

Count of rescue analgesics administration

Description

Number of count of rescue analgesics administered because of patient's request for additional analgesia than IV PCA

Time Frame

Postoperative 0-2, 2-6, 6-24, 24-48 hours

Title

Opioid side effects

Description

Incidence of opioid side effects like postoperative nausea/vomiting, hypotension, dizziness, somnolence and respiratory depression (%)

Time Frame

Postoperative 0-2, 2-6, 6-24, 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 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hojin Lee, PhD

Phone

82-2-2072-2467

zenerdiode03@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Susie Yoon, PhD

Phone

82-2-2072-2467

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

Phone

82-2-2072-2467

zenerdiode03@gmail.com

First Name & Middle Initial & Last Name & Degree

Susie Yoon, MD, PhD

Phone

82-2-2072-2467

susiey87@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Preemptive and Preventive Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy

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