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NCT Number: NCT06793527

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University

Krakow, Lesser Poland Voivodeship, Poland

Location status: Recruiting

Location contact

Tomasz Skladzien, phd md

CONTACT

[email protected]

+48 12 400 1800

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Celiac Plexus Block

Drug

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.

ESP block

Drug

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.

Lidacaine

Drug

Instead of a regional block, an intravenous infusion of lidocaine will be used.

Primary outcomes

  1. Life quality

    Time frame: 1 day

    Every patient will do OR-15

Secondary outcomes

  1. posoperative pain

    Time frame: 1 day

    NRS score after operation from 0 to 10

Study contacts

Contact information is provided by the study sponsor or research team.

Tomasz Skladzien, MD PhD

CONTACT

[email protected]

124001800 ext. 48

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Acronym: LECO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
Apr 4, 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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