Intraoperative Autonomic Neural Blockade

• Status: Not yet recruiting
• Trial end date: 2024-05-02
• Target enrollment: 0
• Participant gender: All

Summary

The duration of the effect of autonomic neural blockade (ANB) is the most critical limitation for successful clinical application. The analgesic effect using only 0.5% bupivacaine may wear off after 12 to 18 hours. We have prolonged this effect using a combination of bupivacaine and dexamethasone. In this protocol, we aim to study three different local anesthetic combinations to prolong the effect of the ANB.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Simón Bolívar
• Treatments: Anesthetics; Anesthetics, Local; BB 1101; Bupivacaine; Clonidine; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

All adult patients scheduled for Laparoscopic Sleeve Gastrectomy(LSG) at each participating institution will be eligible for screening for study inclusion and granting of consent to study participation.

Exclusion Criteria:

The exclusion criteria will be the inability to perform an ANB because of anatomical difficulties, the need for revisional surgery, the need for concomitant surgical procedures beyond hiatal hernia repair, conversion to open surgical procedures, allergies to local anesthetics, and intraoperative complications (e.g., visceral or vascular perforations, or anesthesia-related complications requiring admission to intensive care).