Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06793527

Comparison of the Efficacy of Celiac Plexus Blockade, Erector Spinae Compartment Blockade, and Intravenous Lidocaine Infusion Under Opioid-Free Anesthesia in Bariatric Surgery Patients

Led by Jagiellonian University · Updated on 2025-04-04

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating different non-opioid anesthesia methods to manage pain during bariatric surgery. The study compares three approaches: celiac plexus blockade, erector spinae plane (ESP) block, and intravenous lidocaine infusion, all performed under opioid-free anesthesia. This research aims to find which method provides better pain relief and fewer side effects, as opioid use often leads to issues like respiratory depression and nausea. The study is randomized and double-blinded to ensure reliable comparison between the methods. Participants are randomly assigned to one of three groups. The ESP group receives a block of the erector spinae compartment with ropivacaine before general anesthesia. The celiac plexus group receives a ropivacaine block during surgery under general anesthesia, causing no discomfort. The third group receives an intravenous lidocaine infusion instead of a regional block. All patients receive opioid-free anesthesia using ketamine, dexmedetomidine, and sevoflurane, followed by standard pain medications after surgery. During the study, pain levels are measured using the numeric rating scale (NRS) at multiple times within 24 hours after surgery. Patients also complete a quality of recovery questionnaire (QOR-15) the day after surgery, and the frequency of nausea and vomiting is tracked. The study focuses on how well patients recover and their pain management after bariatric surgery. Safety monitoring includes avoiding patients on medications that increase arrhythmia risk. The total follow-up involves assessments within the first postoperative day.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years who underwent laparoscopic bariatric surgery
  • Must be able to sign agreement for study
Not Eligible

You will not qualify if you...

  • 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 < 50 bpm)
  • Hypotension
  • Atrioventricular block
  • Intraventricular or sinus block
  • Blood clotting disorders
  • Pregnant or lactating women
  • Cognitive impairment
  • Unable to read consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of the surgery and immediate perioperative period

Participants receive one of three anesthesia methods during bariatric surgery: a block of the erector spinae compartment before the procedure, a celiac plexus block during general anesthesia, or an intravenous infusion of lidocaine. All participants are anesthetized without opioids and receive standard postoperative analgesic therapy.

1 surgical and anesthesia visit

Follow-up

Duration - 1 day

Participants' pain intensity is assessed at multiple time points within 24 hours after surgery. Quality of recovery and frequency of postoperative nausea and vomiting are also monitored on the day after surgery.

Visits at 1, 2, 6, 12, and 24 hours post-procedure

Trial Site Locations

Total: 1 location

1

Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University

Krakow, Lesser Poland Voivodeship, Poland

Actively Recruiting

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Research Team

T

Tomasz Skladzien, MD PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Impact of Opioid-Free Anesthesia on Analgesia and Recovery Following Bariatric Surgery: a Meta-Analysis of Randomized Controlled Studies.

Kuo-Chuan Hung, Chong-Chi Chiu, Chih-Wei Hsu...

https://pubmed.ncbi.nlm.nih.gov/35854095