Analgesia iv vs Epidural Analgesia vs Port-sites Infiltration After Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be divided into 3 groups: Analgesia iv exclusively (Group 1), epidural analgesia+analgesia iv (Group 2) and port-sites infiltration+analgesia iv (Group 3). Pain will be quantified by means of a Visual Analogic Scale and morphine rescue needs were determined 24 hours after surgery.

Detailed Description
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A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be randomized using a computerized simple randomization scheme in a 1:1:1 ratio into 3 groups: those patients receiving only intravenous analgesia (Group 1), those ones receiving intravenous analgesia associated to epidural analgesia (Group 2) and those patients receiving intravenous analgesia associated with port-sites infiltration with bupivacaine. Pain quantification as measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) will be evaluated 24 hours after surgery.

Official Title
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Postoperative Pain After Laparoscopic Sleeve Gastrectomy: Comparison of Isolated Intravenous Analgesia, Epidural Analgesia Associated With Analgesia iv and Port-sites Infiltration With Bupivacaine Associated With Analgesia iv

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Port-sites infiltration:Bupivacaine0.25%
* Drug: Epidural analgesia:Levobupivacaine0,125%
* Drug: Metamizole and Acetaminophen iv


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index (BMI) >40 Kg/m2 BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity Exclusion Criteria: patients undergoing other bariatric techniques severe underlying cardiovascular diseases chronic renal failure hepatic dysfunction previous foregut surgery patients with any contraindication for bariatric surgery
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Port-sites infiltration:Bupivacaine0,25%<br>Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port. Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours. | Drug: Port-sites infiltration:Bupivacaine0.25%<br>* Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.<br>* Other names: Port-sites infiltration with bupivacaine;Drug: Metamizole and Acetaminophen iv<br>* Associated Intravenous analgesia include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.<br>* Other names: Analgesia iv;|
| Experimental: Epidural analgesia:Levobupivacaine0.125%<br>Epidural analgesia consists in the placement of a thoracic epidural catheter inserted at the level T6-T7 and administration of a continuous perfusion of Levobupivacaine 0.125% 6ml/h. Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours. | Drug: Epidural analgesia:Levobupivacaine0,125%<br>* Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.<br>* Other names: Epidural analgesia;Drug: Metamizole and Acetaminophen iv<br>* Associated Intravenous analgesia include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.<br>* Other names: Analgesia iv;|
| Active Comparator: Metamizole and Acetaminophen iv<br>Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours. | Drug: Metamizole and Acetaminophen iv<br>* Associated Intravenous analgesia include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.<br>* Other names: Analgesia iv;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain measured by Visual Analogic Scale | Postoperative pain will be measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) 24 hours after surgery, | 24 hours after surgery |