Back to resultsAdditive Effect of Intravenous Acetaminophen on Postoperative Pain Control
Primary Purpose
Postoperative Pain, Gynecologic Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Patients in this group will receive 1 gram of acetaminophen intravenously after the end of surgery.
Patients in this group will receive 100 ml of normal saline intravenously after the end of surgery.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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")
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")
Postoperative nausea and vomiting
4-scales scoring (none; mild; moderate; severe)
Opioid-related adverse effect
Incidence of respiratory, gastrointestinal, and central nervous system complications
Use of alternative analgesics
Additional administration of other analgesics
Length of stay
Hospital length of stay
Full Information
NCT ID
NCT03644147
First Posted
August 21, 2018
Last Updated
January 7, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03644147
Brief Title
Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
January 6, 2021 (Actual)
Study Completion Date
January 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Gynecologic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients in this group will receive 1 gram of acetaminophen intravenously after the end of surgery.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in this group will receive 100 ml of normal saline intravenously after the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
treatment
Intervention Description
Acetaminophen will be intravenously administrated to treatment group after the end of surgery.
Primary Outcome Measure Information:
Title
Total volume of administered analgesics during postoperative 24 hours
Description
morphine equivalent dose of patient-controlled analgesics administered during first 24 hours after end of surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain score
Description
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
Title
Patient satisfaction score
Description
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
Title
Postoperative nausea and vomiting
Description
4-scales scoring (none; mild; moderate; severe)
Time Frame
24 hours
Title
Opioid-related adverse effect
Description
Incidence of respiratory, gastrointestinal, and central nervous system complications
Time Frame
24 hours
Title
Use of alternative analgesics
Description
Additional administration of other analgesics
Time Frame
24 hours
Title
Length of stay
Description
Hospital length of stay
Time Frame
From date of hospital admission until the date of discharge, an average of 1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, Pf.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
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Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control
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