Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia.

Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia. Impact on Anesthetic Agents Consumption: A Randomized Clinical Trial Protocol

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

Study Overview

• Status: Completed
• Conditions: Anesthesia Morbidity; Opioid Use
• Intervention / Treatment: Other: PG-ANB performed at the outset of LSG; Other: PG-ANB performed at the end of the LSG

Detailed Description

Balanced general anesthesia, even if combined with local anesthesia or parietal blocks such as transversus abdominis plane (TAP), subcostal, or pararectal blocks, is insufficient to block the autonomic impulses released during most intra-abdominal visceral surgeries, especially in laparoscopic sleeve gastrectomy (LSG). These impulses are, in part, responsible for the hemodynamic changes observed during different phases of LSG and the subsequent visceral pain and associated symptoms, such as nausea and vomiting, observed in a substantial number of patients in the immediate postoperative period after LSG and other minimally invasive procedures. Visceral pain substantially impacts patients' quality of life, recovery time, nursing time allocation, and resultant risk of opioid abuse. Nausea, food intolerance, and pain are responsible for most readmissions after LSG and other bariatric procedures. Many of these patients have associated severe respiratory impairments and other comorbidities. They often need increased amounts of halogenated anesthetics, opioid analgesics, antiemetics, and other anesthetic modalities such as epidural anesthesia. A recent randomized clinical trial (RCT) demonstrated that a novel approach, namely paragastric autonomic neural blockade (PG-ANB), is safe and effective in addressing visceral pain while reducing the need for analgesics, including opioids and the decreasing nausea and vomiting in the first 24 hours after a laparoscopic sleeve gastrectomy. In an observational series, we found that by performing PG-ANB as the first step in LSG, the need for morphine-equivalent doses and halogenated anesthetics diminished, and hemodynamic stability increased while maintaining the previously reported reduction of postoperative visceral pain and associated symptoms. Similarly, when implementing a variation of the autonomic blockade targeting proper pathways as an early step in cholecystectomy, the same beneficial effects were observed in affected patients.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080020
      • clinicas Portoazul e Iberoamerica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PG-ANB performed at the outset of LSG; 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; 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.
Active Comparator: PG-ANB performed at the end of LSG; PG-ANB is performed at the end of the sleeve gastrectomy	Other: PG-ANB performed at the end of the LSG; 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>

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovery from anesthesia measured by the Modified Aldrete Scale	The Modified Aldrete scale from 0 to 15 (a higher score correlates with better recovery from anesthesia) will be assessed and recorded 15 minutes and 1 hour after surgery.	one hour after surgery

Collaborators and Investigators

• Sponsor: Universidad Simón Bolívar
• Investigators: Study Chair: Rafael Pantoja, MD, Universidad Simón Bolívar

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: November 26, 2022
• First Submitted That Met QC Criteria: December 24, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Anesthetics; Opioids; Autonomic; Blockade; Recovery time
• Other Study ID Numbers: PRO-CEI-USB-CE-0394-01; PRO-CEI-USB-CE-0394-02 (Unisimon)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No