Lidocaine Versus ESP - After Bariatric Surgery

April 5, 2025 updated by: Tomasz Skladzien, Jagiellonian University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Kraków, Poland, 31501
        • Jagiellonian University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lidocaine
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.
Drug: Lidocaine IV
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
Experimental: ESP block
Ultrasound-guided continuous ESP block with opioid PCA A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T7/T8 spinous process. A Contiplex Echo ultra 360 18G needle with 20G × 55 cm Contiplex Echo catheter will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.35% ropivacaine
Drug: Ropivacaine injection
30ml of 0.35% ropivacaine
Other Names:
  • ESP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total long acting opioid consumption in oxycodone equivalents
Time Frame: 1 day
the total dosage of given drug
1 day
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.
1 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Study Chair: Tomasz Skladzien, MD PHD, Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.6120.249.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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