Multimodal Analgesia for Cholecystectomy

Study Overview
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Brief Summary
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It is important to decrease the postoperative pain in patients undergoing laparoscopic cholecystectomy. We will compare the pharmacologic analgesia with the parmacologic and surgical analgesia in patients undergoing laparoscopic cholecystectomy.

Official Title
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The Comparison of Multimodal Analgesic Protocols for Laparoscopic Cholecystectomy: Pharmacologic Interventions and Combination of Pharmacologic and Operative Interventions

Conditions
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Laparoscopic Cholecystectomy

Intervention / Treatment
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* Drug: Celebrex, acetaminophen, and dexamethasone
* Procedure: Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective laparoscopic cholecystectomy Exclusion Criteria: Recent gastric ulcer disease Hepatic or renal insufficiency Opioid dependency Coagulopathy Pre-existing neurologic or anatomic deficits in the lower extremities Severe psychiatric illness pregnancy

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pharmacological group<br>Pharmacological analgesia will be performed | Drug: Celebrex, acetaminophen, and dexamethasone<br>* Pharmacological intervention will be performed. Celebrex 200mg, acetaminophen 1g, and dexamethasone 7 mg will be infused perioperatively.<br>* Other names: Pharmacological;|
| Experimental: Pharmacologican and surgical group<br>Pharmacological and surgical analgesia will be performed. | Drug: Celebrex, acetaminophen, and dexamethasone<br>* Pharmacological intervention will be performed. Celebrex 200mg, acetaminophen 1g, and dexamethasone 7 mg will be infused perioperatively.<br>* Other names: Pharmacological;Procedure: Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum<br>* Surgical intervention will be performed. Saline irrigation, aspiration of pneumoperitoneum, and low pressure pneumoperitoneum will be performed.<br>* Other names: Surgical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve of postoperative pain for 24 hour | Area under curve will be measured using Postoperative pain score at postoperative 24 hour using visual anlogue scale (0: no pain, 10: most imaginable pain). | At postoperative 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score, | Postoperative pain score: postoperative pain score will be measured at postoperative 0, 2, 6, and 24 hour using visual anlogue scale (0: no pain, 10: most imaginable pain). | At postoperative 0, 2, 6, and 24 hour | 
| Analgesic requirements, | Analgesic requirements will be measured at postoperative 24 hour. Total dose of tramadol, ketorolac, and pethidine will be assessed at postoperative 24 hour. | At postoperative 24 hour | 
| Sleep quality | Sleep quality will be measured using sleep quality questionnare at postoperative 24 hour. using sleep quality questionnare. | At postoperative 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain