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

NCT06793527 | Recruiting DMC

• 1 other identifier: 1072.6120.116.2024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anaesthesia; Anesthesia and Analgesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Life quality

  Every patient will do OR-15

  1 day

Secondary Outcomes (1)

• posoperative pain

  1 day

Study Arms (3)

Erector Spinal BLock

EXPERIMENTAL

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

Celiac Plexus Block

EXPERIMENTAL

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

Lidocaine IV

PLACEBO COMPARATOR

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

Drug: Lidacaine

Interventions

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.

Celiac Plexus Block

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.

Erector Spinal BLock

Lidacaine DRUG

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

Lidocaine IV

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University

Krakow, Lesser Poland Voivodeship, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 35854095 RESULT

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomasz Skladzien, MD PhD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Skladzien, MD PhD

CONTACT

124001800; tomasz.skladzien@uj.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: February 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)