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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06793527
Acronym
LECO
Enrollment
300
Registered
2025-01-27
Start date
2025-02-06
Completion date
2026-12-31
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia and Analgesia, Regional Anaesthesia

Keywords

ESP, celiac plexus block, OFA, erector spinal plane block, opioid free anesthesia

Brief 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.

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.

Interventions

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.

DRUGESP 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.

DRUGLidacaine

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

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Life quality1 dayEvery patient will do OR-15

Secondary

MeasureTime frameDescription
posoperative pain1 dayNRS score after operation from 0 to 10

Countries

Poland

Contacts

Primary ContactTomasz Skladzien, MD PhD
tomasz.skladzien@uj.edu.pl124001800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026