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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opiranserin+Acetaminophen group | Experimental | In the Opiranserin+Acetaminophen group, opiranserine 1000mg infusion will be provided over 10 hr. IV Acetaminophen 1g will be provided q 8h until 24 h potperatively. |
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| Acetaminophen+NSAIDs group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opiranserin+Acetaminophen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Until 12 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Song | Contact | 02-2019-6692 | NEARMYHEART@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital | Not yet recruiting | Seoul | 06273 | South Korea |
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Participants will be randomly assigned to either the Treatement group (opiranserin + acetaminophen) or the control group (NSAIDs + acetaminophen) in a 1:1 ratio.
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Participants, care providers, investigators, and oucome assessors will be blinded to the group assignment.
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| Acetaminophen+NSAIDs | Drug | 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. |
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| until 24hours postoperatively |
| opioid consumption | 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. | 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. | at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively |
| time to first rescue analgesics | time to first rescue analgesic requirements | until 24hours |
| incidence of nausea, vomiting | incidence of nausea, vomiting during postoperative 24 hours | 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. | 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. | 24hours postoperatively |
| hospital length of stay | length of hospitalization | 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. | 24hours postoperatively |
| Gangnam Severance Hospital | Recruiting | Seoul | 06273 | South Korea |
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