Cholecystectomy, Laparoscopic, Cholecystectomy, Robotic
Conditions
Brief summary
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.
Interventions
DRUGOpiranserin+Acetaminophen
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.
DRUGAcetaminophen+NSAIDs
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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, care providers, investigators, and oucome assessors will be blinded to the group assignment.
Intervention model description
Participants will be randomly assigned to either the Treatement group (opiranserin + acetaminophen) or the control group (NSAIDs + acetaminophen) in a 1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient undergoing minimally invasive cholecystectomy
Exclusion criteria
* 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 * severe hepatic impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve of the pain score at rest through 12 hours (NRS·h) | Until 12 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve of the pain score at rest through 24 hours | until 24hours postoperatively | 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. |
| opioid consumption | until 24hours postopratively | — |
| pain at rest | at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively | 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. |
| pain during movement | at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively | 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 to first rescue analgesics | until 24hours | time to first rescue analgesic requirements |
| incidence of nausea, vomiting | until 24hours | incidence of nausea, vomiting during postoperative 24 hours |
| nausea severity | until 24hours | 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. |
| patient satisfaction | 24hours postoperatively | 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. |
| hospital length of stay | until discharge, about 1-7 days | length of hospitalization |
| Quality of Recovery | 24hours postoperatively | 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. |
Countries
South Korea
Contacts
CONTACTYoung Song
Outcome results
None listed