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PK/PD Levobupivacaine with and Without Epinephrine After Ultrasound Guided ESP Block

NCT04799184 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-03-12

No results posted yet for this study

Summary

Currently there is no standardized management or single technique to manage postoperative pain after Video-assisted thoracic surgery (VATS), there are many options available ranging from intravenous opioids, morphine or fentanyl Patient-controlled analgesia (PCA), peripheral nerve blocks, intercostals, paravertebral and epidural blocks. Erector Spinal Block (ESP), this blocks the ventral and dorsal branch of the unilateral thoracic roots. It corresponds to an interfacial block that produces an extensive multidermatomal sensitive block with a single puncture, covering the anterior, lateral and posterior aspect of the thorax. One of its main advantages would be safety, possible less damage to nerves and pneumothorax, as well as the simplicity of execution of this block. What has positioned it as another analgesic alternative in this type of surgery.

The pharmacokinetic profile that local anesthetics would have when injected into this interfacial compartment has not yet been described, and what the real impact of the use of vasoconstrictor will be in terms of plasma levels and duration of the block.

Our objective is to compare the plasma levels of levobupivacaine achieved after performing an ESP Block with or without epinephrine.

Conditions

  • Anesthetics Complications
  • Anesthetic Toxicity
  • Bupivacaine Overdose
  • Nerve Block
  • Surgery

Interventions

DRUG

Levobupivacaine 0.25% with epinephrine 5 ug/ml

The block will be performed under ultrasound vision at T5 level, with the patient seated. Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% with epinephrine 5 ug / ml until completing a volume of 20 ml in fractional form.

DRUG

Levobupivacaine 0.25% without epinephrine 5 ug/ml

The block will be performed under ultrasound vision at T5 level, with the patient seated. Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% without epinephrine 5 ug / ml until completing a volume of 20 ml in fractional form.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Andrea Araneda, MD · Clinician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2021-08-01
Completion
2022-03-09

Countries

  • Chile

Study Locations

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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 NCT04799184 on ClinicalTrials.gov