Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia.

NCT05668845 | Completed

• 2 other identifiers: PRO-CEI-USB-CE-0394-01PRO-CEI-USB-CE-0394-02
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of early autonomic blockade on the consumption of remifentanil and halogenated anesthesia in the intraoperative period during laparoscopic sleeve gastrectomy.

Conditions

Opioid Use; Anesthesia Morbidity

Keywords

Autonomic; Blockade; Opioids; Anesthetics; Recovery time

Outcome Measures

Primary Outcomes (2)

• Intraoperative Remifentanil consumption

  The amount of remifentanil administered will be calculated based on the amount of the consumed mix and reported as total mcg and mcg/kg/min.

  duration of the anesthesia

• Intraoperative consumption of the halogenated agent (sevoflurane)

  The anesthetic machine will determine the administered amount of sevoflurane (Dräger Primus) which will be reported in ml/min.

  duration of the anesthesia

Secondary Outcomes (1)

• recovery from anesthesia measured by the Modified Aldrete Scale

  one hour after surgery

Study Arms (2)

PG-ANB performed at the outset of LSG

EXPERIMENTAL

PG-ANB is performed early in the procedure as a first step before starting the sleeve gastrectomy.

Other: PG-ANB performed at the outset of LSG

PG-ANB performed at the end of LSG

ACTIVE COMPARATOR

PG-ANB is performed at the end of the sleeve gastrectomy

Other: PG-ANB performed at the end of the LSG

Interventions

PG-ANB performed at the outset of LSG OTHER

The paragastric lesser omentum neural block is performed with a 25-gauge needle attached to a venous catheter extension introduced through the left 12-mm port. The needle is capped during its introduction, and the cap is removed inside the abdomen using a grasper and kept under direct vision. Infiltration of 20 mL of non-diluted 0.5% bupivacaine is performed at six levels with careful aspiration preceding fluid infiltration. Four areas are adjacent to the vagus nerves and branches, and two are in the vicinity of the common hepatic and left gastric arteries. This is performed at the outset of the LSG.

PG-ANB performed at the outset of LSG

PG-ANB performed at the end of the LSG OTHER

The paragastric lesser omentum neural block is performed with a 25-gauge needle attached to a venous catheter extension introduced through the left 12-mm port. The needle is capped during its introduction, and the cap is removed inside the abdomen using a grasper and kept under direct vision. Infiltration of 20 mL of non-diluted 0.5% bupivacaine is performed at six levels with careful aspiration preceding fluid infiltration. Four areas are adjacent to the vagus nerves and branches, and two are in the vicinity of the common hepatic and left gastric arteries. This is performed at the end of the LSG\>

PG-ANB performed at the end of LSG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all adult patients scheduled for LSG at each participating institution.

You may not qualify if:

• the inability to perform a PG-ANB because of anatomical difficulties
• the need for revisional surgery
• the need for concomitant hiatal hernia repair or other surgical procedures
• conversion to open surgical procedures
• allergies to local anesthetics or medication described in the anesthesia protocol
• intraoperative complications (e.g., visceral or vascular perforations)
• anesthesia-related complications requiring admission to intensive care

Sponsors & Collaborators

• Universidad Simón Bolívar: lead

Study Sites (1)

clinicas Portoazul e Iberoamerica

Barranquilla, Atlántico, 080020, Colombia

Location

Related Publications (2)

• Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.

  PMID: 36050617 BACKGROUND

• Daes J, Pantoja R, Luquetta J, Luque E, Hanssen A, Rocha J, Morrell DJ. Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):581-589. doi: 10.1213/ANE.0000000000006769. Epub 2023 Dec 13.

  PMID: 38091501 DERIVED

Study Officials

• Rafael Pantoja, MD

  Universidad Simón Bolívar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patient and the independent investigator assessing and recording the patient's data will be blinded to treatment arm assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 30, 2022
• Study Start: February 1, 2023
• Primary Completion: April 15, 2023
• Study Completion: May 1, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)