Postoperative PainNCT03644147
Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control
A study testing Acetaminophen in people with Postoperative Pain and Gynecologic Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aimed to evaluate the additive effect of acetaminophen on postoperative pain control in patients receiving nefopam and fentanyl-based patient-controlled analgesia. Participants undergoing laparoscopic hysterectomy will be randomly assigned to treatment group or control group. Read more about this study
- Who is it for?
- Ages 19 to 80 years, women only
- Conditions the study is for
- Postoperative Pain, Gynecologic Disease
- What is being tested?
- Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Aug 2018to 7 Jan 2021
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing total laparoscopic hysterectomy due to uterine myoma, cervical cancer, endometriosis, uterine prolapse
Who cannot join
- Liver disease (aspartate transaminase OR alanine transaminase > 80 IU/L)
- Chronic kidney disease (GFR < 30 ml/min/1.73m2)
- History of drug allergy
- Chronic pain lasting more than 3 months
- Conversion to laparotomy
- Complex surgery (co-operation with colon surgeon or urologist)
- Limitation in expressing pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additive Effect of Intravenous Acetaminophen Administered at the End of Surgery on Postoperative Pain Control With Nefopam and Fentanyl-based Patient-controlled Analgesia: A Double-blind Randomized Controlled Trial
This study aimed to evaluate the additive effect of acetaminophen on postoperative pain control in patients receiving nefopam and fentanyl-based patient-controlled analgesia.
Participants undergoing laparoscopic hysterectomy will be randomly assigned to treatment group or control group. After end of surgery, acetaminophen or normal saline (placebo) will be administered intravenously depending on the group assigned.
- Conditions
- Postoperative Pain, Gynecologic Disease
- Being tested
- Acetaminophen
- Medical subject headings
- Pain, Postoperative, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called treatment
Acetaminophen will be intravenously administrated to treatment group after the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients in this group will receive 1 gram of acetaminophen intravenously after the end of surgery. Receives: Drug: Acetaminophen |
| Control | No intervention | Patients in this group will receive 100 ml of normal saline intravenously after the end of surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of administered analgesics during postoperative 24 hours
morphine equivalent dose of patient-controlled analgesics administered during first 24 hours after end of surgery
Measured: 24 hours
Secondary outcomes (6)
Pain score
11-point numeric rating scale ranging from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: 24 hours
Patient satisfaction score
11-point numeric rating scale ranging from '0' representing one extreme (e.g. "extremely dissatisfied") to '10' representing the other extreme (e.g. "extremely satisfied")
Measured: 24 hours
Postoperative nausea and vomiting
4-scales scoring (none; mild; moderate; severe)
Measured: 24 hours
Opioid-related adverse effect
Incidence of respiratory, gastrointestinal, and central nervous system complications
Measured: 24 hours
Use of alternative analgesics
Additional administration of other analgesics
Measured: 24 hours
Length of stay
Hospital length of stay
Measured: From date of hospital admission until the date of discharge, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start27 Aug 2018
- Primary completion6 Jan 2021
- Study completion7 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double-blind randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, Pf., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644147
- Sponsor's protocol ID
- H-1807-151-961
- Status last verified
- Jan 2021
- First submitted
- 21 Aug 2018
- Last updated
- 8 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nam S, Yoo S, Park SK, Kim JT. Additive effect of a single intravenous dose of acetaminophen administered at the end of laparoscopic hysterectomy on postoperative pain control with nefopam and fentanyl-based patient-controlled analgesia: a double-blind, randomized controlled trial. BMC Anesthesiol. 2025 Feb 20;25(1):88. doi: 10.1186/s12871-025-02971-w.
PubMed 39979845
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effect of Intravenous Acetaminophen Administered at the End of Surgery on Postoperative Pain Control With Nefopam and Fentanyl-based Patient-controlled Analgesia: A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03644147
- Acronym / sponsor ID
- H-1807-151-961
- Conditions
- Postoperative Pain, Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 23 Aug 2018 (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 study aimed to evaluate the additive effect of acetaminophen on postoperative pain control in patients receiving nefopam and fentanyl-based patient-controlled analgesia.
Participants undergoing laparoscopic hysterectomy will be randomly assigned to treatment group or control group. After end of surgery, acetaminophen or normal saline (placebo) will be administered intravenously depending on the group assigned.
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
- Double-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: AcetaminophenPatients in this group will receive 1 gram of acetaminophen intravenously after the end of surgery. |
| Control | No intervention | –Patients in this group will receive 100 ml of normal saline intravenously after the end of surgery. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing total laparoscopic hysterectomy due to uterine myoma, cervical cancer, endometriosis, uterine prolapse
Key exclusion criteria (7 listed)
- Liver disease (aspartate transaminase OR alanine transaminase > 80 IU/L)
- Chronic kidney disease (GFR < 30 ml/min/1.73m2)
- History of drug allergy
- Chronic pain lasting more than 3 months
- Conversion to laparotomy
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 |
|---|---|---|
| AcetaminophenAlso: treatmentAcetaminophen will be intravenously administrated to treatment group after the end of surgery. | Drug | Treatment |
Primary outcome
Total volume of administered analgesics during postoperative 24 hours
Time frame: 24 hours
morphine equivalent dose of patient-controlled analgesics administered during first 24 hours after end of surgery
6 secondary outcomes
Pain score
Time frame: 24 hours
Patient satisfaction score
Time frame: 24 hours
Postoperative nausea and vomiting
Time frame: 24 hours
Opioid-related adverse effect
Time frame: 24 hours
Use of alternative analgesics
Time frame: 24 hours
Length of stay
Time frame: From date of hospital admission until the date of discharge, an average of 1 week
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 8 Jan 2021.
- Derived from this study: PubMed 39979845Nam S, Yoo S, Park SK, Kim JT. Additive effect of a single intravenous dose of acetaminophen administered at the end of laparoscopic hysterectomy on postoperative pain control with nefopam and fentanyl-based patient-controlled analgesia: a double-blind, randomized controlled trial. BMC Anesthesiol. 2025 Feb 20;25(1):88. doi: 10.1186/s12871-025-02971-w.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Jin-Tae Kim, Pf. 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 in people with Postoperative Pain and Gynecologic Disease, 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 1 inclusion and 7 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 8 Jan 2021. 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. 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 volume of administered analgesics during postoperative 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644147, which also lists 1 linked publication.
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 8 Jan 2021.