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Completed

NCT Number: NCT03644147

Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control

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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Key information

Conditions

Postoperative Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynecologic Disease Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Urogenital Diseases

Age range

19 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Acetaminophen

Drug

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

Other names: treatment

Primary outcomes

  1. 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

Secondary outcomes

  1. Pain score

    Time frame: 24 hours

    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")

  2. Patient satisfaction score

    Time frame: 24 hours

    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")

  3. Postoperative nausea and vomiting

    Time frame: 24 hours

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

  4. Opioid-related adverse effect

    Time frame: 24 hours

    Incidence of respiratory, gastrointestinal, and central nervous system complications

  5. Use of alternative analgesics

    Time frame: 24 hours

    Additional administration of other analgesics

  6. Length of stay

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

    Hospital length of stay

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2018
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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