Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644147
• Other study ID #: H-1807-151-961
• Status: Completed
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: January 7, 2021

Study information

• Verified date: January 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. After end of surgery, acetaminophen or normal saline (placebo) will be administered intravenously depending on the group assigned.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 7, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Disease
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours
Secondary	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")	24 hours
Secondary	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")	24 hours
Secondary	Postoperative nausea and vomiting	4-scales scoring (none; mild; moderate; severe)	24 hours
Secondary	Opioid-related adverse effect	Incidence of respiratory, gastrointestinal, and central nervous system complications	24 hours
Secondary	Use of alternative analgesics	Additional administration of other analgesics	24 hours
Secondary	Length of stay	Hospital length of stay	From date of hospital admission until the date of discharge, an average of 1 week