Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia. Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia , postoperative complications, pain score and duration of operation time will record.

Detailed Description
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Objective of study : The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia. Material and methods : Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia : abdominal discomfortable, shoulder pain, abdominal pain, nausea, anxiety, dermatomal level of sensory blockade, respiratory depression. We compare between two group; shoulder pain, postoperative complications, pain score, duration of operation time and length of hospital stay. Fifty patients will select prospectively for LC, under low pressure (10 mm Hg) pneumoperitoneum and under combined anesthesia and general anesthesia. Spinal anaesthesia was performed at L1-L2 interspace using 2 ml of 0.5% (10 mg) hyperbaric Bupivacaine mixed with 0.5ml (25 micrograms) of Fentanyl. Epidural catheter was inserted at L1- L2 interspace too.

Official Title
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Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy: a Prospective, Randomized Study

Conditions
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Gall Stone Disease, Polyp

Intervention / Treatment
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* Procedure: combined anesthesia
* Procedure: general anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gall stone disease, polyp Exclusion Criteria: Gall bladder cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>Laparoscopic cholecystectomy in General Anesthesia | Procedure: combined anesthesia<br>* Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy<br>|
| Active Comparator: group 2<br>Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). | Procedure: general anesthesia<br>* General anesthesia for laparoscopic cholecystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Operation | group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes | up to 2 hours | 
| Post-operative Shoulder Pain | Group 1 and Group 2 Post-operative shoulder pain | from end of the operation to postoperative 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Anaesthesia | Group 1 minimum 42 minutes and maximum 83 minutes.mean duration of anaesthesia 60.17 and Group 2 minimum 45 minutes and maximum 82 minutes mean duration of anaesthesia 60.23 | up to 2 hours | 
| Post-operative Abdominal Pain 2nd Hour | VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | pain at postoperative 2nd hour | 
| Post-operative Abdominal Pain 4th Hour | VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | pain at postoperative 4th hour | 
| Post-operative Abdominal Pain 6th Hour | VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | pain at postoperative 6th hour | 
| Post-operative Abdominal Pain 12th Hour | VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | pain at postoperative 12th hour | 
| Post-operative Abdominal Pain 24th Hour | VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. | pain at postoperative 24th hour | 
| Intra-operative Shoulder Pain | Group 1 and Group 2 Intra-operative shoulder pain | during operation time, up to 2 hours | 
| Urinary Retention | Group 1 and Group 2 Urinary retention | from end of the operation to postoperative 1 day | 
| Nausea/Vomiting | Group 1 and group 2 nausea/vomiting | from end of the operation to postoperative 1 day | 
| Headache | Group 1 and Group 2 Headache | from end of the operation to postoperative 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combined anesthesia, General anesthesia, Laparoscopic cholecystectomy