Intraoperative Autonomic Neural Blockade

NCT06137924 | Unknown Phase 3 DMC

• 1 other identifier: PRO-CEI-USB-CE-0394-02
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The duration of the effect of autonomic neural blockade (ANB) is the most critical limitation for successful clinical application. The analgesic effect using only 0.5% bupivacaine may wear off after 12 to 18 hours. We have prolonged this effect using a combination of bupivacaine and dexamethasone. In this protocol, we aim to study three different local anesthetic combinations to prolong the effect of the ANB.

Conditions

Pain, Postoperative; Nausea, Postoperative; Vomiting, Postoperative; Analgesia; Opioid Use

Keywords

autonomic neural blockade; visceral pain; postoperative nausea and vomiting; opioids

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  pain will be measured using an analog visual scale 0-10 being o no pain and 10 the most excruciating pain.

  measured at 1,8,24 and 36 hours after surgery

Secondary Outcomes (5)

• nausea

  at 1,8,24 and 36 hours after surgery

• vomiting

  at 1,8,24 and 36 hours after surgery.

• total doses of analgesics beyond the basic analgesic protocol.

  at 1,8,24 and 36 hours after surgery.

• total doses of opioids required

  at 1,8,24 and 36 hours after surgery

• level of pain in the subgroup of patients with hiatal hernia repair

  at 1, 8, 24 and 36 hours after surgery

Study Arms (3)

ANB with 0.5% bupivacaine plus dexamethasone 8 mg

ACTIVE COMPARATOR

ANB will be performed using 5% bupivacaine 20 cc plus dexamethasone 8 mg as the local anesthetic.

Drug: Local anesthetic injection Bupivacaine plus dexamethasone

ANB with 0.5% bupivacaine plus dexamethasone and a colloid

EXPERIMENTAL

ANB will be performed in this group using 0.5% bupivacaine 20 ccs plus dexamethasone 8 mg and a plasma volume substitute (succinylated gel).

Drug: Local anesthetic injection bupivacainde plus dexamethasone plus a colloid

0.5% bupivacaine plus clonidine 0.145 mcg

EXPERIMENTAL

ANB with will be performed in this group using 0.5% bupivacaine 20 ccs plus clonidine 0.145 mcg.

Drug: Local anesthetic injection bupivacaine plus clonidine

Interventions

Local anesthetic injection Bupivacaine plus dexamethasone DRUG

The autonomic neural block is performed with a 25-gauge needle attached to a venous catheter extension introduced through the left 12-mm port. Infiltration of 20 mL of non-diluted 0.5% bupivacaine plus dexamethasone 8 mg is performed at the celiac plexus and vagus nerve trajectory.

ANB with 0.5% bupivacaine plus dexamethasone 8 mg

Local anesthetic injection bupivacainde plus dexamethasone plus a colloid DRUG

bupivacaine plus dexamethasone 8 mg plus a colloid 10 cc (Gelofucin, B. Braun Medical S.A., Crissier, Suiza.) is performed at the celiac plexus and vagus nerve trajectory.

ANB with 0.5% bupivacaine plus dexamethasone and a colloid

Local anesthetic injection bupivacaine plus clonidine DRUG

bupivacaine 5% plus clonidine (0,150mgs) is performed at the celiac plexus and vagus nerve trajectory

0.5% bupivacaine plus clonidine 0.145 mcg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidad Simón Bolívar: lead

Related Publications (4)

• 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.

  PMID: 36050617 BACKGROUND

• Daes J, Pantoja R, Luquetta J, Luque E, Hanssen A, Rocha J, Morrell DJ. Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):581-589. doi: 10.1213/ANE.0000000000006769. Epub 2023 Dec 13.

  PMID: 38091501 BACKGROUND

• Daes J, Rocha J, Luque E, Hanssen A. Comparative effectiveness of bupivacaine- dexamethasone and liposomal bupivacaine for autonomic neural blockade in laparoscopic sleeve gastrectomy: a study on pain, postoperative nausea and vomiting and analgesic consumption. British journal of surgery. Abstract presented at 2023 IBC-University of Oxford World Congress; British Journal of Surgery Oral Abstract Prize Session. Oxford University; London, UK. September 20, 2023. Forthcoming 2023.

  BACKGROUND

• Daes J, Pantoja R, Luque E, Hanssen A, Rocha J, Pauli EM. Intraoperative autonomic neural blockade: comparison between different local anesthetics combinations: a randomized clinical trial. Surg Endosc. 2025 Apr;39(4):2523-2533. doi: 10.1007/s00464-025-11637-0. Epub 2025 Mar 3.

  PMID: 40032662 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Agnosia; Visceral Pain

Interventions

Dexamethasone; Clonidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Nociceptive Pain

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Jorge Daes, MD

CONTACT

+57 3106363636; jorgedaez@gmail.com

Andres Hanssen

CONTACT

+ 57 3123012321; anhanssen@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization will be performed using sealed envelopes stratified by the institution in blocks of six. The data manager will prepare these envelopes. The data manager will store the randomization list containing the final treatment assignments. Only the data manager will have access to the randomization list throughout the study. These sealed envelopes will be placed in the patient's chart and will not be opened until the patient is in the operating room and general anesthesia has been initiated. The patient and the independent investigator assessing and recording the patient's data will be masked to treatment arm assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three arms using different local anesthetic combinations: bupivacaine plus dexamethasone, bupivacaine plus dexamethasone and a plasma substitute and bupivacaine plus clonidine.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: December 2, 2023
• Primary Completion: April 2, 2024
• Study Completion: May 2, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share