NCT05668845

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Universidad Simón Bolívar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use
• Anesthesia Morbidity

Interventions

Type	Name	Description
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.
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\>

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-04-15
• Completion: 2023-05-01
• First posted: 2022-12-30
• Last updated: 2023-05-09

Locations

1 site across 1 country: Colombia