Clinical trial NCT05668845: Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia.
Official title: Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia. Impact on Anesthetic Agents Consumption: A Randomized Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Anesthesia Morbidity
Keywords: Autonomic
Blockade
Opioids
Anesthetics
Recovery time
Lead sponsor: Universidad Simón Bolívar
Sponsor class: OTHER
First posted: 2022-12-30
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Intraoperative Remifentanil consumption
timeFrame: duration of the anesthesia
measure: Intraoperative consumption of the halogenated agent (sevoflurane)
timeFrame: duration of the anesthesia
Secondary outcomes:
measure: recovery from anesthesia measured by the Modified Aldrete Scale
timeFrame: one hour after surgery
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: clinicas Portoazul e Iberoamerica
state: Atlantico
Study officials:
affiliation: Universidad Simón Bolívar
name: Rafael Pantoja, MD
role: STUDY_CHAIR
References:
citation: 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.