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

NCT04799184 | Completed Phase 4 DMC

• 1 other identifier: 170627010
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ESP; Perioperative Care; Bupivacaine Overdose; VATS surgery

Outcome Measures

Primary Outcomes (3)

• Plasma levels of levobupivacaine

  Levobupivacaine plasma levels will be measured using High-performance liquid chromatography.

  5, 10, 20, 30, 60, 90 minutes post block.

• Changes in plasma levels levobupivacaine of the group I v/s group II

  To assess the changes in plasma levels of the group I with epinephrine versus the group II without epinephrine.

  5, 10, 20, 30, 60, 90 minutes post block.

• Sensitive skin extension

  Determine the sensitive skin extension of ESP after its performance using pinprick and temperature discrimination using an alcohol swab.

  15 minutes post-block

Secondary Outcomes (5)

• Pain measured

  Every 15 minutes per 2 hours in the PACU and 12 hrs, 24 hrs, 48 hrs during hospitalization

• Heart Rate

  Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.

• Hemodynamics

  Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.

• Pulse oximetry

  Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.

• Consumption of morphine or its equivalents

  During the first 48 hours including intraoperative and postoperative

Study Arms (2)

Group I Epi

EXPERIMENTAL

The ESP 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 completing a volume of 20 ml.

Drug: Levobupivacaine 0.25% with epinephrine 5 ug/ml

Group II no Epi

ACTIVE COMPARATOR

The ESP 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 completing a volume of 20 ml.

Drug: Levobupivacaine 0.25% without epinephrine 5 ug/ml

Interventions

Levobupivacaine 0.25% with epinephrine 5 ug/ml DRUG

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.

Also known as: ESP, Bupivacaine

Group I Epi

Levobupivacaine 0.25% without epinephrine 5 ug/ml DRUG

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.

Also known as: ESP, Bupivacaine

Group II no Epi

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication of VATS
• ASA I-II
• Body mass index (BMI) 20-34 kg / m2

You may not qualify if:

• Patients with conversion to thoracotomy
• History of chronic pain
• Drug abuse
• Psychiatric illness
• Allergic to some of the drugs used in the study
• Chronic analgesic users
• History of peripheral neuropathy
• Who refuse the procedure

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 450881, Chile

Location

Related Publications (2)

• Corvetto MA, Echevarria GC, De La Fuente N, Mosqueira L, Solari S, Altermatt FR. Comparison of plasma concentrations of levobupivacaine with and without epinephrine for transversus abdominis plane block. Reg Anesth Pain Med. 2012 Nov-Dec;37(6):633-7. doi: 10.1097/AAP.0b013e31826c330a.

  PMID: 23038415 BACKGROUND

• Araneda A, De la Cuadra JC, Corvetto M, Balde D, Fuente R, Ibacache M, Contreras V, Solari S, Cortinez I. Pharmacokinetic modelling and simulation for prolonged infusion of levobupivacaine with or without epinephrine in transversus abdominis plane and erector spinae plane blocks: a randomised controlled trial and analysis of pooled data. Br J Anaesth. 2025 Oct;135(4):1051-1058. doi: 10.1016/j.bja.2025.05.047. Epub 2025 Jul 9.

  PMID: 40640046 DERIVED

MeSH Terms

Interventions

Levobupivacaine; Epinephrine; Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Andrea Araneda, MD

  Clinician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into two groups, this will be done through a table of computer-generated random numbers. Group I will receive ESP block with vasoconstrictor and Group II will receive ESP block without vasoconstrictor.

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: April 3, 2019
• Primary Completion: August 1, 2021
• Study Completion: March 9, 2022
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the paper publication
• Access Criteria: Researchers and clinicians related to the analgesic management of patients, upon formal request via e-mail to the research director.

Locations

CL (1)