Skip to main content
OpenTrials
Completed

NCT Number: NCT05668845

Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia.

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

clinicas Portoazul e Iberoamerica

Barranquilla, Atlántico, 080020, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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>

Primary outcomes

  1. Intraoperative Remifentanil consumption

    Time frame: duration of the anesthesia

    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.

  2. Intraoperative consumption of the halogenated agent (sevoflurane)

    Time frame: duration of the anesthesia

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

Secondary outcomes

  1. recovery from anesthesia measured by the Modified Aldrete Scale

    Time frame: one hour after surgery

    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.

Sponsors and collaborators

Lead sponsor

Universidad Simón Bolívar

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 30, 2022
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.