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NCT Number: NCT05700214

Lidocaine Versus ESP - After Bariatric Surgery

The Erector Spinal Block (ESP) is based on the deposition of the local anesthetic in the inter-fascial space between the dorsal extensor muscle and the intercostal muscles at the height of the transverse processes. The scope of the blockade covers the dorsal and ventral branches of the thoracic spinal nerves, but also in most cases the investigetors are able to obtain a wide distribution of the drug into the paravertebral space by "permeating" the local anesthetic through the fascial compartments. The clinical effect of the blockade is due to blocking the nerve structures of the paravertebral space (spinal nerve branches and the sympathetic trunk). The scope of the blockade, after its execution at the level of Th5, most often includes the segments from Th1 to L1.

Lidocaine used in intravenous infusion is one of the recommended components of multidirectional analgesia. Its adjuvant properties make it possible to reduce the amount of opioid drugs used, and thus - to reduce the frequency of their side effects.

The aim of the study is to test the effectiveness and safety of the use of lidocaine infusion or Erector Spinal Block in multimodal analgesic management.

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Key information

Conditions

Anesthetics Acute Pain Local Anesthetics Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jagiellonian University

Krakow, 31501, Poland

About this study

In bariatric surgery, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after labdomen surgery may predict development of chronic pain. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients requiring bariatric surgery Obesity (BMI>35)

Exclusion criteria

Patient refusal Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation Known allergy to local anesthetics Inability to provide informed consent Any patient on opioids for greater than or equal to 3 months duration prior to surgery Patients with chronic pain syndromes

Treatment and study plan

Ropivacaine injection

Drug

30ml of 0.35% ropivacaine

Other names: ESP block

Lidocaine IV

Drug

Before induction bolus of 1% lidocaine 1,5mg/kg IBW i.v., continuous infusion of 1% lidocaine intraoperatively rate 1 mg/kg IBW i.v.

Other names: Lidocaine infusion

Primary outcomes

  1. Total long acting opioid consumption in oxycodone equivalents

    Time frame: 1 day

    the total dosage of given drug

  2. Pain scores will be recorded at intervals.

    Time frame: 1 days

    The Numerical Rating Scale (NRS) is an 11-point scale where 0 is no pain and 10 is the worst pain imaginable.

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Continuous Infusion of Lidocaine Versus Blockade of the Erector Spinae Plane Block - Comparison of Analgesic Efficacy in Patients After Bariatric Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2023
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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