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

Last updated: April 2, 2025
Sponsor: Jagiellonian University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Celiac Disease

Treatment

Celiac Plexus Block

ESP block

Lidacaine

Clinical Study ID

NCT06793527
1072.6120.116.2024
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over 18 years who underwent laparoscopic bariatric surgery

  • Must be able to sign agreement for study

Exclusion

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 Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Celiac Plexus Block
Phase:
Study Start date:
February 06, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University

    Kraków, Malopolskie
    Poland

    Active - Recruiting

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