Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia.

Universidad Simón Bolívar

Status: Completed

Conditions: Anesthesia Morbidity; Opioid Use

Treatments: Other: PG-ANB performed at the end of the LSG; Other: PG-ANB performed at the outset of LSG

Study type: Interventional

Funder types: Other

Identifiers

NCT05668845

PRO-CEI-USB-CE-0394-02 (Other Identifier)

PRO-CEI-USB-CE-0394-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 2 patient groups

PG-ANB performed at the outset of LSG

Experimental group

Description:

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

Treatment:

Other: PG-ANB performed at the outset of LSG

PG-ANB performed at the end of LSG

Active Comparator group

Description:

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

Treatment:

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