Multimodal and Unimodal Analgesia in Cholecystectomy

Study Overview
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Brief Summary
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Many surgical procedures are accompanied by postoperative pain with severity moderate, severe or extreme and insufficient postoperative pain control may cause risk of post-surgical complications and risk of chronic post-surgical pain The targets of preoperative pain management are to relieve patient suffering, reduce length of hospital stay and achieve early mobilization after surgery, decreasing opioid consumption and its side effects that are constipation, nausea, vomiting, dizziness, respiratory depression which is the most feared complication being life-threatening and some less common side effects as sedation

Official Title
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Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy

Conditions
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Compare Unimodal and Multimodal Analgesics

Intervention / Treatment
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* Drug: Pregabalin 150mg
* Drug: Acetaminophen 1 G Oral Tablet
* Drug: Celecoxib 400Mg Oral Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing laparoscopic cholecystectomy Patients older than 18 years old Exclusion Criteria: Renal or hepatic or cardiac impairment patients Patients with chronic pain history Allergic patients after taking aspirin or other NSAIDs patients with active gastrointestinal bleeding, ulcer and inflammatory bowel diseases or cerebrovascular bleeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: multimodal<br>pregabalin/ acetaminophen/ celecoxib | Drug: Pregabalin 150mg<br>* Pregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group<br>Drug: Acetaminophen 1 G Oral Tablet<br>* Acetaminophen 1 G Oral Tablet preoperative in multi-modal group<br>Drug: Celecoxib 400Mg Oral Capsule<br>* Celecoxib 400Mg Oral Capsule preoperative in multi-modal group<br>|
| Active Comparator: unimodal<br>Pregabalin | Drug: Pregabalin 150mg<br>* Pregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group<br>|
| No Intervention: control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative visual analogue scale (VAS) | The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity. | 24 hour postoperative | 
| Amount of post operative Needed opioid analgesia | ampules of opioid analgesia needed after operation | 24 hour postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type and amount of prescribed post operative non opioid analgesia | Type and amount of prescribed post operative non opioid analgesia | 24 hour postoperative |