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CompletedNCT03644147Updated Jan 8, 2021

Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control

An interventional study of Acetaminophen in Postoperative Pain and Gynecologic Disease, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-08.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
Female
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Study 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. After end of surgery, acetaminophen or normal saline (placebo) will be administered intravenously depending on the group assigned.

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Conditions studied

  • Postoperative Pain
  • Gynecologic Disease
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In context

Genital Diseases, Female

154 studies on the registry are indexed under Genital Diseases, Female; 32 are open to participants now.

This study's enrollment of 84 is close to the median of 80 across 111 interventional studies indexed under Genital Diseases, Female.

Browse Genital Diseases, Female studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patients undergoing total laparoscopic hysterectomy due to uterine myoma, cervical cancer, endometriosis, uterine prolapse

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Treatment

    Patients in this group will receive 1 gram of acetaminophen intravenously after the end of surgery.

    Drug: Acetaminophen

  • No intervention
    Control

    Patients in this group will receive 100 ml of normal saline intravenously after the end of surgery.

Interventions

  • DrugAcetaminophen

    Acetaminophen will be intravenously administrated to treatment group after the end of surgery.

    Also known as: treatment

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 hours

Secondary outcomes

  1. 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")

    Time frame: 24 hours

  2. 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")

    Time frame: 24 hours

  3. Postoperative nausea and vomiting

    4-scales scoring (none; mild; moderate; severe)

    Time frame: 24 hours

  4. Opioid-related adverse effect

    Incidence of respiratory, gastrointestinal, and central nervous system complications

    Time frame: 24 hours

  5. Use of alternative analgesics

    Additional administration of other analgesics

    Time frame: 24 hours

  6. Length of stay

    Hospital length of stay

    Time frame: From date of hospital admission until the date of discharge, an average of 1 week

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Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03644147
Lead sponsor
Seoul National University Hospital
Responsible party
Jin-Tae Kim (Professor, Seoul National University Hospital) — Principal investigator
First posted
Aug 23, 2018
Start date
Aug 27, 2018
Primary completion
Jan 6, 2021
Completion
Jan 7, 2021
Last update
Jan 8, 2021

Study contacts

Jin-Tae Kim, Pf.
principal investigator · Seoul National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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