The purpose of this study is to evaluate whether the combination therapy of opiranserin and acetaminophen is non-inferior to the combination of non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen for postoperative pain management after minimally invasive cholecystectomy. This is a single-center, randomized, controlled, non-inferiority clinical trial in adult patients undergoing minimally invasive cholecystectomy. Participants will be randomly assigned to either the Treatement group (opiranserin + acetaminophen) or the control group (NSAIDs + acetaminophen) in a 1:1 ratio to compare the analgesic efficacy and safety between the two analgesic regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
In the Opiranserin+Acetaminophen group, opiranserine 1000mg infusion will be provided over 10 hr. Opiranserin infusion will be started after the indduction of anesthesia. After laoding dose (160mg ) over 30 minutes, maintenace dose (840mg) will be infused over 9hr 30min. IV Acetaminophen 1g will be provided q 8h until 24 h potperatively.
In the Acetaminophen+NSAIDs group, Normal saline 500 ml will be provided over 10hr. IV Acetaminophen 1g and ibuprofen 300mg will be provided q 8h until 24 h potperatively.
Gangnam Severance Hospital
Seoul, South Korea
NOT_YET_RECRUITINGGangnam Severance Hospital
Seoul, South Korea
RECRUITINGArea under the curve of the pain score at rest through 12 hours (NRS·h)
Area under the curve of the numeric rating scale pain score at rest through 12 hours (Numerical Rating Scale·h), Pain score will be assess with the numerical rating scale (NRS), ranging from 0 (0, no pain) to 10 (maximum, worst pain), higher scores indicate greater pain intensity.
Time frame: Until 12 hours postoperatively
Area under the curve of the pain score at rest through 24 hours
Area under the curve of the numeric rating scale pain score at rest through 24 hours. Area under the curve of the numeric rating scale pain score at rest through 24 hours (Numerical Rating Scale·h), Pain score will be assess with the numerical rating scale (NRS), ranging from 0 (0, no pain) to 10 (maximum, worst pain), higher scores indicate greater pain intensity.
Time frame: until 24hours postoperatively
opioid consumption
Time frame: until 24hours postopratively
pain at rest
numeric rating scale pain score at rest, Pain score will be assess with the numerical rating scale (NRS), ranging from 0 (0, no pain) to 10 (maximum, worst pain), higher scores indicate greater pain intensity.
Time frame: at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively
pain during movement
numeric rating scale pain score during movement Pain score will be assess with the numerical rating scale (NRS), ranging from 0 (0, no pain) to 10 (maximum, worst pain), higher scores indicate greater pain intensity.
Time frame: at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively
time to first rescue analgesics
time to first rescue analgesic requirements
Time frame: until 24hours
incidence of nausea, vomiting
incidence of nausea, vomiting during postoperative 24 hours
Time frame: until 24hours
nausea severity
severity of nausea using 0-10 numeric rating scale Nausea severity will be assess with the numerical rating scale (NRS), ranging from 0 (0, no nausea) to 10 (maximum, worst nausea), higher scores indicate greater nausea severity.
Time frame: until 24hours
patient satisfaction
patient satisfaction regarding pain management asked at 24 hours postoperatively, using 0-10 scale Patient satisfaction will be assessd with the numerical rating scale (NRS), ranging from 0 (0, totally unsatisfied) to 10 (maximum, totally satisfied), higher scores indicate greater patient satisfaction.
Time frame: 24hours postoperatively
hospital length of stay
length of hospitalization
Time frame: until discharge, about 1-7 days
Quality of Recovery
Questionnaire of 15-item Quality of Recovery (QoR-15). Each item is scored on an 11-point numerical rating scale from 0 to 10. Total score range: Minimum 0 to maximum 150. Higher values indicate a better quality of postoperative recovery.
Time frame: 24hours postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.