Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07084753

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • For patients receiving thoracic paravertebral block (TPVB):
  • the presence of infection at the puncture site
  • For the OFA group:
  • 2nd or 3rd-degree atrioventricular block
  • bradycardia with a heart rate below 50 beats per minute
  • coronary artery disease,
  • cardiomyopathy.

Treatment and study plan

Levobupivacaine

Drug

Used in thoracic paravertebral block: 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level (six levels, at the Th5, Th7, and Th9 levels bilaterally; a total of 200 mg of levobupivacaine, 8 mg of dexamethasone and 240 mcg of adrenaline).

Dexamethasone contained in the solution for thoracic paravertebral block

Drug

Used in thoracic paravertebral block: 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level (six levels, at the Th5, Th7, and Th9 levels bilaterally; a total of 200 mg of levobupivacaine, 8 mg of dexamethasone and 240 mcg of adrenaline).

Adrenaline

Drug

Used in thoracic paravertebral block: 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level (six levels, at the Th5, Th7, and Th9 levels bilaterally; a total of 200 mg of levobupivacaine, 8 mg of dexamethasone and 240 mcg of adrenaline).

Dexmedetomidin

Drug

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. The anesthetic mixture was maintained at a rate of 5-10 ml per hour.

ketamine

Drug

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. The anesthetic mixture was maintained at a rate of 5-10 ml per hour.

Lidocain

Drug

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. The anesthetic mixture was maintained at a rate of 5-10 ml per hour.

Sufentanil

Drug

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.

Opioid free anesthesia based on thoracic paravertebral block

Procedure

Patients scheduled for laparoscopic sleeve gastrectomy will be anesthetized without the use of opioids, with general anesthesia and pain blockade using a thoracic paravertebral block

Other names: OFA based on TPVB

Opioid based Anesthesia

Procedure

Patients scheduled for laparoscopic sleeve gastrectomy will be anesthetized with opioids and general anesthesia

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

Procedure

Patients who are scheduled for laparoscopic gastrectomy will be anesthetized without the use of opioids and under general anesthesia, with analgesia by intravenous administration of dexmedetomidine, ketamine and lidocaine.

Other names: OFA

Ultrasound guided thoracic paravertebral block

Device

Patients are positioned prone, with the identification of the 1st rib achieved using a convex XX Hz ultrasound probe. The left and right transverse processes of the 5th, 7th, and 9th thoracic vertebrae are marked accordingly. TPVB is executed in a paramedian sagittal oblique scan utilizing an in-plane needle insertion approach at the Th5, Th7, and Th9 levels bilaterally. An insulated echogenic needle, sized between 10-15 cm and 22-20 G, is employed. The skin and subcutaneous tissue at each level are infiltrated with 1.5 ml of 1% lidocaine.

Ultrasound guidance combined with nerve stimulation (dual monitoring) is utilized at each corresponding paravertebral space. Verification of the paravertebral space is established through visualization of pleural displacement, as observed via the ultrasound probe following the injection of 1 ml of 5% glucose, as well as via a motor response at a current intensity of 0.3-0.5 mA.

Other names: Ultrasound guided TPVB

Nerve stimulator for peripheral nerve blocks

Device

During the application of the thoracic paravertebral block, verification of the distance of the insulated echogenic needle tip from the thoracic spinal nerve is monitored using via a motor response at a current intensity of 0.3-0.5 mA.

Metoclopramide 10mg

Drug

To prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg) and metoclopramide (10 mg) intraoperatively

Ondasetron 4mg

Drug

To prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intraoperatively.

Thiethylperazine

Drug

To prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg) and thiethylperazine (6.5 mg) intravenously.

Dexamethasone, 8 mg intravenously

Drug

To prevent postoperative nausea and vomiting (PONV), patients receive intraoperatively dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intravenously.

Primary outcomes

  1. a) Postoperative pain levels measured by the 0-10 Numerical rating scale (NRS). b) Opioid analgesic consumption (Morphine milligram equivalents- MME).

    Time frame: 10 days

    • Self-reported pain levels recorded at multiple time points:30 minutes post- surgery, every three hours for the first 24 hours, and three times daily for the following nine days. Zero indicates no pain, ten is the worst possible pain.
    • Use of opioids (sufentanil, pethidine, tramadol) before, during and after surgery. Sufentanil in micrograms, pethidine and tramadol in milligrams. Values are converted into Morphine milligram equivalents (MME),

Secondary outcomes

  1. a) Self-reported incidence of PONV after surgery. b) Time in the postoperative care unit (PACU) after surgery. c) Time to first mobilization after surgery. d) Time to fluid intake after surgery.

    Time frame: 10 days

    • Recorded with a yes and no response.
    • Measured in minutes (recorded in the patient's monitoring sheet).
    • Measured in minutes (self-reported by the patient).
    • Measured in minutes (self-reported by the patient).

Study contacts

Contact information is provided by the study sponsor or research team.

IVO JURISIC, MD

CONTACT

[email protected]

+385989050015

VESNA JURISIC, MD

CONTACT

[email protected]

38598508833

Sponsors and collaborators

Lead sponsor

IVO JURISIC

Other

Registry information

Official study title

Comparison of Opioid-based Anesthesia, Opioid-free Anesthesia Based on Intravenous Drugs and Opioid-free Anesthesia With Thoracic Paravertebral Block, in Patients Undergoing Laparoscopic Gastric Bypass Surgery for Obesity

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.