Clinical trial
Non-opioid Anesthesia Based on Thoracic Paravertebral Block During Laparoscopic Sleeve Gastrectomy
Opening soon · Not applicable · 1 countries · Registry ID NCT07084753
What this study is 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.
Basic eligibility
Full registry criteria
Treatments and study arms
Levobupivacaine
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
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
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
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
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
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
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
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
Opioid based Anesthesia
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
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.
Ultrasound guided thoracic paravertebral block
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.
Nerve stimulator for peripheral nerve blocks
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
To prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg) and metoclopramide (10 mg) intraoperatively
Ondasetron 4mg
To prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intraoperatively.
Thiethylperazine
To prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg) and thiethylperazine (6.5 mg) intravenously.
Dexamethasone, 8 mg intravenously
To prevent postoperative nausea and vomiting (PONV), patients receive intraoperatively dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intravenously.
Primary outcomes
1. 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. 2. 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),
Study locations
1 locations were listed when this page was built. The first 40 are shown.