Comparison of the Efficacy of Celiac Plexus Blockade, ESP and Lidocaine Infusion Under OFA (LECO)

Comparison of the Efficacy of Celiac Plexus Blockade, Erector Spinae Compartment Blockade (ESP), and Intravenous Lidocaine Infusion Under Opioid-free Anesthesia in Patients Undergoing Bariatric Surgery

Modern anesthesiology, in search of alternatives to opioid-based pain management, is turning to low-opioid and non-opioid protocols. Replacing opioids with non-opioid analgesics, co-analgesics, and regional and local anesthesia techniques allows avoiding the adverse effects of opioids while maintaining satisfactory analgesia. This is of particular importance in bariatric surgery, where reducing the incidence of respiratory depression, sedation, opioid hyperalgesia, and postoperative nausea and vomiting is a priority. Standard non-opioid anesthesia (OFA) includes ketamine, lidocaine, and dexmedetomidine infusions, while regional techniques additionally reduce the need for analgesics. Despite the widespread use of these methods, there is no clear data on the superiority of any of them in bariatric procedures.

Study Overview

• Status: Recruiting
• Conditions: Regional Anaesthesia; Anesthesia and Analgesia
• Intervention / Treatment: Drug: ESP block; Drug: Celiac Plexus Block; Drug: Lidacaine

Detailed Description

This is a prospective, randomized study with random assignment of patients to three groups:

ESP group: Before the procedure, a block of the erector spinae (ESP) compartment will be performed with approximately 20 ml of 0.25% ropivacaine at the Th4 level. The patient will be informed about the possibility of short-term discomfort if the block is performed before full induction of anesthesia.

Celiac plexus group: During general anesthesia, a celiac plexus block will be performed intraoperatively (20 ml of 0.5% ropivacaine). The patient will not feel discomfort due to general anesthesia.

Lidocaine IV group: Instead of a regional block, an intravenous infusion of lidocaine will be used.

All three methods are recognized methods of perioperative anesthesia. There is no placebo group in the study - intravenous infusion of lidocaine is the reference method, and both regional blocks are compared in relation to it and to each other.

All groups will be anesthetized without opioids using ketamine, dexmedetomidine and inhaled sevoflurane. After surgery, patients will receive standard analgesic therapy (oxycodone with naloxone, paracetamol, metamizole, dexketoprofen). They will be informed about the possible side effects of opioids, although the main goal is to minimize their use during the procedure.

Pain intensity will be assessed using the NRS scale at 1, 2, 6, 12 and 24 hours after the procedure. In addition, on the postoperative day, the patient will complete the QOR-15 questionnaire, and the frequency of postoperative nausea and vomiting will also be monitored.

The choice of ropivacaine is due to its more favorable cardiotoxicity profile compared to bupivacaine. The exclusion criteria will include, among others, patients taking medications that may increase the risk of arrhythmia.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomasz Skladzien, MD PhD; Phone Number: 48 124001800; Email: tomasz.skladzien@uj.edu.pl

Study Locations

• Poland
  • Malopolskie
    • Kraków, Malopolskie, Poland
      • Recruiting
      • Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University
      • Contact: Tomasz Skladzien, phd md; Phone Number: +48 12 400 1800; Email: tomasz.skladzien@uj.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients over 18 years who underwent laparoscopic bariatric surgery
• Must be able to sign agreement for study

Exclusion Criteria:

• Patients with a history of allergic reactions to drugs
• Patients with a history of drug addiction
• Patients with chronic pain who require analgesics
• History of hospitalization for psychiatric disorders
• Preoperative pulse oximetry (SpO2) < 95 %
• bradycardia (HR<50bpm)
• hypotension
• atrioventricular block
• intraventricular or sinus block
• Blood clotting disorders
• Pregnant/lactating women
• Cognitive impairment
• Unable to read consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Celiac Plexus Block; During general anesthesia, a celiac plexus block will be performed intraoperatively (20 ml of 0.5% ropivacaine). The patient will not feel discomfort due to general anesthesia.	Drug: Celiac Plexus Block; During general anesthesia, a celiac plexus block will be performed intraoperatively (20 ml of 0.5% ropivacaine). The patient will not feel discomfort due to general anesthesia.
Placebo Comparator: Lidocaine IV; Instead of a regional block, an intravenous infusion of lidocaine will be used.	Drug: Lidacaine; Instead of a regional block, an intravenous infusion of lidocaine will be used.
Experimental: Erector Spinal BLock; Before the procedure, a block of the erector spinae (ESP) compartment will be performed with approximately 20 ml of 0.25% ropivacaine at the Th4 level. The patient will be informed about the possibility of short-term discomfort if the block is performed before full induction of anesthesia.	Drug: ESP block; Before the procedure, a block of the erector spinae (ESP) compartment will be performed with approximately 20 ml of 0.25% ropivacaine at the Th4 level. The patient will be informed about the possibility of short-term discomfort if the block is performed before full induction of anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life quality	Every patient will do OR-15	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
posoperative pain	NRS score after operation from 0 to 10	1 day

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Principal Investigator: Tomasz Skladzien, MD PhD, Jagiellonian University

Publications and helpful links

General Publications

• Hung KC, Chiu CC, Hsu CW, Lin CM, Liao SW, Teng IC, Chen IW, Sun CK. Impact of Opioid-Free Anesthesia on Analgesia and Recovery Following Bariatric Surgery: a Meta-Analysis of Randomized Controlled Studies. Obes Surg. 2022 Sep;32(9):3113-3124. doi: 10.1007/s11695-022-06213-7. Epub 2022 Jul 19.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: celiac plexus block; ESP; opioid free anesthesia; erector spinal plane block; OFA
• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: 1072.6120.116.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Our patients do not agree on share their data

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