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Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03644147
Collaborator
(none)
84
Enrollment
1
Location
2
Arms
28.4
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-blind randomized controlled trialDouble-blind randomized controlled trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 27, 2018
Actual Primary Completion Date :
Jan 6, 2021
Actual Study Completion Date :
Jan 7, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

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

Drug: Acetaminophen
Acetaminophen will be intravenously administrated to treatment group after the end of surgery.
Other Names:
  • treatment

    		•
    No Intervention: Control

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

    Outcome Measures

    Primary Outcome Measures

    1. Total volume of administered analgesics during postoperative 24 hours [24 hours]

      morphine equivalent dose of patient-controlled analgesics administered during first 24 hours after end of surgery

    Secondary Outcome Measures

    1. Pain score [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 [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 [24 hours]

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

    4. Opioid-related adverse effect [24 hours]

      Incidence of respiratory, gastrointestinal, and central nervous system complications

    5. Use of alternative analgesics [24 hours]

      Additional administration of other analgesics

    6. Length of stay [From date of hospital admission until the date of discharge, an average of 1 week]

      Hospital length of stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 03080

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Jin-Tae Kim, Pf., Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jin-Tae Kim, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03644147
    Other Study ID Numbers:
    • H-1807-151-961
    First Posted:
    Aug 23, 2018
    Last Update Posted:
    Jan 8, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Acetaminophen

    Study Results

    No Results Posted as of Jan 8, 2021