Postoperative PainNCT05366777
Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption
A study testing acetaminophen/ibuprofen fixed-dose combination and Saline in people with Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- acetaminophen/ibuprofen fixed-dose combination and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Oct 2022to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- acetaminophen/ibuprofen fixed-dose combination, Saline
- Keywords
- Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophen/ibuprofen fixed-dose combinationDrug
Also called Maxigesic
Intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (total 100 ml)
SalineDrug
Also called Placebo
100 ml of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Maxigesic group | Experimental | 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. Receives: Drug: acetaminophen/ibuprofen fixed-dose combination |
| Control group | Placebo comparator | 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fentanyl consumption during 24 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Measured: postoperative 24 hours
Secondary outcomes (4)
Total fentanyl consumption
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Measured: postoperative 6, 48 hours
Postoperative pain score
11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"
Measured: postoperative 6, 24, 48 hours
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (%)
Measured: postoperative 24, 48 hours
Quality of recovery-15
Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"
Measured: postoperative 24, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start3 Oct 2022
- Primary completion14 Jul 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized double-blinded study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyongbo Pharmaceutical
- Responsible party
- Principal investigator, Hojin Lee, MD, Seoul National University Hospital
- Investigators
- Hojin Lee, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366777
- Sponsor's protocol ID
- Maxigesic_Lung
- Status last verified
- Dec 2023
- First submitted
- 4 May 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05366777
- Acronym / sponsor ID
- Maxigesic_Lung
- Conditions
- Postoperative Pain
- Keywords
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Kyongbo Pharmaceutical
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective randomized double-blinded study
| Arm | Type | Receives |
|---|---|---|
| Maxigesic group | Experimental | Drug: acetaminophen/ibuprofen fixed-dose combinationAt 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. |
| Control group | Placebo comparator | Drug: SalineAt 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetaminophen/ibuprofen fixed-dose combinationAlso: MaxigesicIntravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (total 100 ml) | Drug | Maxigesic group |
| SalineAlso: Placebo100 ml of normal saline | Drug | Control group |
Primary outcome
Total fentanyl consumption during 24 hours
Time frame: postoperative 24 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
4 secondary outcomes
Total fentanyl consumption
Time frame: postoperative 6, 48 hours
Postoperative pain score
Time frame: postoperative 6, 24, 48 hours
Postoperative nausea and vomiting
Time frame: postoperative 24, 48 hours
Quality of recovery-15
Time frame: postoperative 24, 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hojin Lee, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetaminophen/ibuprofen fixed-dose combination and Saline in people with Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fentanyl consumption during 24 hours (time frame: postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.