Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively

Detailed Description
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The incidence of pain after laparoscopy may be as high as 36 to 63 percent and is attributed to the carbon dioxide gas (CO2) used to induce pneumo-peritoneum1. The residual part of CO2 remains in the peritoneal cavity for several days after the operation and causes stretching of the phrenic nerve endings, local hypothermia, and diaphragmatic irritation by carbonic acid formation

Official Title
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Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

Conditions
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Perioperative Pain

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: isotonic saline
* Drug: Bupivacaine + morphine
* Drug: Bupivacaine + morphine + ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for Laparoscopic cholecystectomy. Age spectrum of 18 - 55 years ASA I, II Have no comorbid chronic medical diseases Exclusion Criteria: Patients with co morbid medical diseases Age outside the specified range Acute inflammation of the gall bladder Critically ill patient Emergency operations Patient refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine group<br> | Drug: Bupivacaine<br>* instillation of local anaesthetic in the abdominal cavity at the end of the procedure<br>|
| Active Comparator: bupivacaine + morphine<br> | Drug: Bupivacaine + morphine<br>* instillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure<br>|
| Active Comparator: bupivacaine + morphine + ketamine<br> | Drug: Bupivacaine + morphine + ketamine<br>* instillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure<br>|
| Placebo Comparator: isotonic saline<br> | Drug: isotonic saline<br>* instillation of local anaesthetic in the abdominal cavity at the end of the procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative level of ACTH hormone | a stress marker that increase with pain and surgery | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VISUUEAL ANALOGE SCORE | to assess postoperative pain | 24 hours |