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

Phase 3 Completed 147 enrolled Hospital General Universitario Elche

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2012-01
Primary completion: 2015-12
Completion: 2015-12

Publications

Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupivacaine	Other / unclassified	0.25 %	Other
Subject	Bupivacaine	Other / unclassified	10 ml	Other
Subject	Levobupivacaine	Other / unclassified	0.125 %	Other
Subject	Levobupivacaine	Other / unclassified	6 ml	Other
Background	Acetaminophen	Small molecule	1 g	Intravenous
Background	Metamizole	Unknown	2 g	Intravenous

Indications

No indication recorded.