Clinical trial NCT06793527: Comparison of the Efficacy of Celiac Plexus Blockade, ESP and Lidocaine Infusion Under OFA
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Regional Anaesthesia
Anesthesia and Analgesia
Keywords: ESP
celiac plexus block
OFA
erector spinal plane block
opioid free anesthesia
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Life quality
timeFrame: 1 day
Secondary outcomes:
measure: posoperative pain
timeFrame: 1 day
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University
state: Malopolskie
Study officials:
affiliation: Jagiellonian University
name: Tomasz Skladzien, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.