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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662660
• Other study ID #: HGUE 16-03
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2016
• Last updated: January 20, 2016
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Port-sites infiltration:Bupivacaine0.25%
Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.
• Epidural analgesia:Levobupivacaine0,125%
Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.
• Metamizole and Acetaminophen iv
Associated Intravenous analgesia include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No