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Intraoperative Autonomic Neural Blockade

NCT06137924 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

DRUG

Local anesthetic injection Bupivacaine plus dexamethasone

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.

DRUG

Local anesthetic injection bupivacainde plus dexamethasone plus a colloid

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.

DRUG

Local anesthetic injection bupivacaine plus clonidine

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

Sponsors & Collaborators

  • Universidad Simón Bolívar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-02
Primary Completion
2024-04-02
Completion
2024-05-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06137924 on ClinicalTrials.gov