Opiranserin for Minimally Invasive Cholecystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorGangnam Severance Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient undergoing minimally invasive cholecystectomy
Disqualifiers
Known hypersensitivity or allergy to acetaminophen, NSAIDs, opiranserin, or fentanyl.
pre-existing chronic pain,
clinically significant ECG findings (QRS > 200 msec, QTcF >450 msec)
severe renal impairment
Trial design
Design model
Parallel
Treatments tested in this trial
Opiranserin+Acetaminophen
DrugIn 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.
Acetaminophen+NSAIDs
DrugIn 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.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Opiranserin+Acetaminophen groupExperimental treatment 1 intervention
Group B: Acetaminophen+NSAIDs groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Area 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 postoperativelySecondary outcomes
1
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 postoperatively2
opioid consumption
Time frame
until 24hours postopratively3
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 postoperatively4
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 postoperativelySponsors and contacts
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Source ClinicalTrials.gov