Non-opioid Anesthesia Based on Thoracic Paravertebral Block During Laparoscopic Sleeve Gastrectomy

IVO JURISIC

Status: Not yet enrolling

Conditions: Postoperative Pain; Postoperative Analgesia; Bariatric Surgical Pain; Bariatric Surgery (Sleeve Gastrectomy ); PONV; Thoracic Paravertebral Block; Obese Patients; Non-Opioid Pain Management; Opioid Free Anesthesia

Treatments: Drug: Metoclopramide 10mg; Procedure: Opioid based Anesthesia; Drug: ketamine; Drug: Dexamethasone contained in the solution for thoracic paravertebral block; Procedure: Opioid free anesthesia based on thoracic paravertebral block; Drug: Thiethylperazine; Drug: Adrenaline; Device: Ultrasound guided thoracic paravertebral block; Drug: Sufentanil; Drug: Dexamethasone, 8 mg intravenously; Drug: Dexmedetomidin; Drug: Levobupivacaine; Device: Nerve stimulator for peripheral nerve blocks; Procedure: Opioid free anesthesia, Opioid free anesthesia based on intravenous dexmedetomidine, ketamine and lidocainedexmedetomidine, ketamine and lidocaine; Drug: Lidocain; Drug: Ondasetron 4mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07084753

2023- 2301-08

Details and patient eligibility

About

Regional anesthesia is a technique in which a local anesthetic is injected near a nerve or spinal cord to block sensation, motor stimulation, and pain. In this study, an ultrasound-guided paravertebral block will be used, with careful consideration of all positive and negative factors and possible complications. A thoracic paravertebral block is performed by inserting a needle into the intercostal spaces on the back, approximately 4 cm lateral to the spine. Many studies support excellent pain control with this technique, during and after surgery in thoracic and abdominal surgery. Investigators aim to achieve faster patient mobility after surgery, rapid recovery of bowel function, reduced nausea and vomiting, and maximum pain control. The use of opioids, which can additionally cause respiratory suppression and drowsiness, is avoided.

At any time in case of need to switch from laparoscopic to open surgery, equally adequate anesthesia and postoperative analgesia are ensured without the need to change the approach to the same. In this study, the basic scientific assumption (hypothesis) of the researchers is that non-opioid anesthesia with thoracic paravertebral block provides adequate pain control during and long-term after the surgical procedure, without the side effects of opioid anesthesia.

The main goal of the study is to determine which type of anesthesia results in the best pain control and most significantly reduces complications of anesthesia and surgery in overweight patients who are scheduled for laparoscopic longitudinal gastrectomy and partial/total gastrectomy.

Full description

Morbid obese patients scheduled for laparoscopic sleeve gastric resection need specific care during surgery and post-surgery. Postoperative pain management of these patients after this type of surgery is a challenge because of the high prevalence of nausea, vomiting, and higher risk of respiratory depression in obese patients, making the use of opioids undesirable. Various techniques have been used during and after surgery to control moderate to severe pain for early mobilization: OFA (opioid-free anesthesia) based on intravenous use of dexmedetomidine, ketamine, and lidocaine, or OBA (opioid-based anesthesia) in combination with regional anesthesia, to reduce the use of opioids. Regional anesthesia can be used as an additional modality of analgesia within OFA (opioid-free anesthesia) or opioid-based anesthesia (OBA), which either completely avoid the use of opioids or significantly reduce them. Investigators will compare opioid-based general anesthesia (OBA group) as the standard of anesthesia for bariatric surgery with intraoperative opioid- free anesthesia based on thoracic paravertebral block (TPVB group) and intraoperative opioid-free anesthesia based on intravenous dexmedetomidine, ketamine, and lidocaine (OFA group). The primary objective is to compare pain levels as measured by the 0-10 NRS and to compare opioid and analgesic consumption in the perioperative period.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-. patients with a prior history of treatment by a multidisciplinary obesity team scheduled for laparoscopic sleeve gastrectomy (LSG)

• body mass index of 30 kg/m² or greater
• patients classified as ASA status 2-3.

Exclusion criteria

• allergies to the intended medications
• patient refusal
• uncontrolled psychiatric disorders
• intracranial pathology
• cerebrovascular damage
• any factors impairing effective communication

Additional Exclusion Criteria:

1. For patients receiving thoracic paravertebral block (TPVB):

   • the presence of infection at the puncture site

2. For the OFA group:

   • 2nd or 3rd-degree atrioventricular block
   • bradycardia with a heart rate below 50 beats per minute
   • coronary artery disease,
   • cardiomyopathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Opioid based anesthesia (OBA)

Active Comparator group

Description:

Premedication: pantoprazole 40 mg i.v. 1h before surgery. Following three-minute preoxygenation, sufentanil (5 to 15 micrograms), propofol (1 to 2 mg/kg ideal body weight), and rocuronium (0.8 to 1 mg/kg ideal body weight) are administered intravenously during induction of anesthesia. Anesthesia is sustained with sevoflurane maintained at 0.6-1.3 MAC. Sufentanil is added at the assessment of the anesthesiologist in the operating room. To prevent postoperative nausea and vomiting (PONV), patients receive intraoperatively dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intravenously. Intraoperative pain management includes metamizole (2.5 g) and acetaminophen (1 g). For pain levels of 4 or higher on a numerical rating scale (NRS), treatment options include metamizole (2.5 g), pethidine (25 to 100 mg), or tramadol (100 mg). For nausea and vomiting, intravenous doses of ondansetron or metoclopramide are provided as needed.

Treatment:

Drug: Ondasetron 4mg

Drug: Dexamethasone, 8 mg intravenously

Drug: Sufentanil

Procedure: Opioid based Anesthesia

Drug: Metoclopramide 10mg

Opioid free anesthesia (OFA) based on lidocain, dexmedetomidine and S-ketamine

Active Comparator group

Description:

Premedication: pregabalin 75 mg peroraly et pantoprazole 40mg i.v. A pre-prepared 50 ml syringe is utilized, containing 400 mcg of dexmedetomidine (4 ml), 50 mg of S-ketamine (2 ml), 400 mg of 2% lidocaine (20 ml), and 0.9% NaCl to a total volume of 40 ml. Anesthesia is commenced with the infusion from syringe 1 over a 10-minute period at a rate of 15 ml/hour. After this initial period, anesthetic induction is conducted using propofol at a dose of 1-2 mg/kg IBW and rocuronium at 0.8-1 mg/kg IBW. Anesthesia is sustained with sevoflurane maintained at 0.5-1 MAC, adjusted per BIS readings. The anesthetic mixture was maintained at a rate of 5-10 ml per hour adjusted according to the patient's blood pressure and pulse. Intraoperative pain management includes metamizole (2.5 g) and acetaminophen (1 g). To prevent nausea and vomiting, patients receive intraoperative dexamethasone 8 mg and thiethylperazine 6.5 mg intravenously.

Treatment:

Procedure: Opioid free anesthesia, Opioid free anesthesia based on intravenous dexmedetomidine, ketamine and lidocainedexmedetomidine, ketamine and lidocaine

Drug: Lidocain

Drug: Dexmedetomidin

Drug: Dexamethasone, 8 mg intravenously

Drug: Thiethylperazine

Drug: ketamine

Opioid free anesthesia based on thoracic paravertebral block (TPVB)

Experimental group

Description:

Premedication: pantoprazol 40mg i.v. Preoperative TPVB is executed at the Th5, Th7, and Th9 levels bilaterally. The skin at each level are infiltrated with 1.5 ml of 1% lidocaine. Subsequently, 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level and flushed with 1 ml of 5% glucose. In the operating room a induction is carried out with propofol administered at a dosage of 2-2.5 mg/kg of ideal body weight (IBW) and rocuronium at 0.8-1 mg/kg of IBW. Anesthesia is maintained with an infusion of propofol at 100 mcg/kg of total body weight (TBW) per minute, with adjustments made to achieve a targeted BIS value between 40-60. Intraoperative pain management includes metamizole (2.5 g) and acetaminophen (1 g). Prophylaxis of PONV is dexamethasone 8 mg previously administered within the thoracic paravertebral block, with intraoperative administration of 10 mg metoclopramide. Completely opioid-free interventions.

Treatment:

Device: Nerve stimulator for peripheral nerve blocks

Drug: Levobupivacaine

Device: Ultrasound guided thoracic paravertebral block

Drug: Adrenaline

Procedure: Opioid free anesthesia based on thoracic paravertebral block

Drug: Dexamethasone contained in the solution for thoracic paravertebral block

Drug: Metoclopramide 10mg