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
Overview
- Phase
- Not Applicable
- Intervention
- Acetaminophen
- Conditions
- Postoperative Pain
- Sponsor
- Seoul National University Hospital
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Total volume of administered analgesics during postoperative 24 hours
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Jin-Tae Kim
Professor
Seoul National University Hospital
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
Arms & Interventions
Treatment
Patients in this group will receive 1 gram of acetaminophen intravenously after the end of surgery.
Intervention: Acetaminophen
Outcomes
Primary Outcomes
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
- Use of alternative analgesics(24 hours)
- Length of stay(From date of hospital admission until the date of discharge, an average of 1 week)
- Pain score(24 hours)
- Patient satisfaction score(24 hours)
- Postoperative nausea and vomiting(24 hours)
- Opioid-related adverse effect(24 hours)