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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid based anesthesia (OBA) | Active Comparator | 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. |
|
| Opioid free anesthesia (OFA) based on lidocain, dexmedetomidine and S-ketamine | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| a) Postoperative pain levels measured by the 0-10 Numerical rating scale (NRS). b) Opioid analgesic consumption (Morphine milligram equivalents- MME). |
| 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
|
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Inclusion Criteria:
-. patients with a prior history of treatment by a multidisciplinary obesity team scheduled for laparoscopic sleeve gastrectomy (LSG)
Exclusion Criteria:
Additional Exclusion Criteria:
For patients receiving thoracic paravertebral block (TPVB):
- the presence of infection at the puncture site
For the OFA group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| IVO JURISIC, MD | Contact | +385989050015 | i.jurisic.kbd@gmail.com | |
| VESNA JURISIC, MD | Contact | 38598508833 | v.jurisic03@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| IVO JURISIC, MD | University Hospital Dubrava | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Dubrava | Zagreb | City of Zagreb | 10000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33417101 | Background | El Fawal MH, Mohammed DA, Abou-Abbass H, Abbas M, Tamim H, Kanawati S. Laparoscopic Sleeve Gastrectomy under Awake Paravertebral Blockade Versus General Anesthesia: Comparison of Short-Term Outcomes. Obes Surg. 2021 May;31(5):1921-1928. doi: 10.1007/s11695-020-05197-6. Epub 2021 Jan 8. | |
| 25756905 | Background |
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The plan is for the data to be made available after the study is completed and the article is published. Patients will be recorded by numbers and names will be omitted due to the General Data Protection Regulation (names will be known to the researcher). Access to the data will be possible upon request by a professional and with the approval of the University Hospital Dubrava Review Board.
The plan is for the data to be available after the study is completed and the article is published, within 365 days of the publication date.
Access to the data will be possible upon request of experts to the researcher's e-mail and with the approval of the Review Board of the University Hospital Dubrava. When using data from this study for your own research or scientific work (presentation, article), it is mandatory to cite the author of this study as a co-author.
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Tthree groups of patients, each with 12 patients:
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| Opioid free anesthesia based on thoracic paravertebral block (TPVB) | Experimental | 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. |
|
|
| 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 |
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
| 10 days |
| Kanawati S, Fawal H, Maaliki H, Naja ZM. Laparoscopic sleeve gastrectomy in five awake obese patients using paravertebral and superficial cervical plexus blockade. Anaesthesia. 2015 Aug;70(8):993-5. doi: 10.1111/anae.13037. Epub 2015 Mar 10. |
| 29077813 | Background | Subramani Y, Nagappa M, Wong J, Patra J, Chung F. Death or near-death in patients with obstructive sleep apnoea: a compendium of case reports of critical complications. Br J Anaesth. 2017 Nov 1;119(5):885-899. doi: 10.1093/bja/aex341. |
| 14627460 | Background | Frey WC, Pilcher J. Obstructive sleep-related breathing disorders in patients evaluated for bariatric surgery. Obes Surg. 2003 Oct;13(5):676-83. doi: 10.1381/096089203322509228. |
| 31785720 | Background | Beloeil H. Opioid-free anesthesia. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):353-360. doi: 10.1016/j.bpa.2019.09.002. Epub 2019 Sep 26. |
| 30810425 | Background | Gabriel RA, Swisher MW, Sztain JF, Furnish TJ, Ilfeld BM, Said ET. State of the art opioid-sparing strategies for post-operative pain in adult surgical patients. Expert Opin Pharmacother. 2019 Jun;20(8):949-961. doi: 10.1080/14656566.2019.1583743. Epub 2019 Feb 27. |
| 31609155 | Background | Oderda GM, Senagore AJ, Morland K, Iqbal SU, Kugel M, Liu S, Habib AS. Opioid-related respiratory and gastrointestinal adverse events in patients with acute postoperative pain: prevalence, predictors, and burden. J Pain Palliat Care Pharmacother. 2019 Sep-Dec;33(3-4):82-97. doi: 10.1080/15360288.2019.1668902. Epub 2019 Oct 14. |
| 28263427 | Background | Tashani OA, Astita R, Sharp D, Johnson MI. Body mass index and distribution of body fat can influence sensory detection and pain sensitivity. Eur J Pain. 2017 Aug;21(7):1186-1196. doi: 10.1002/ejp.1019. Epub 2017 Mar 6. |
| 29307519 | Background | Phillips BT, Shikora SA. The history of metabolic and bariatric surgery: Development of standards for patient safety and efficacy. Metabolism. 2018 Feb;79:97-107. doi: 10.1016/j.metabol.2017.12.010. Epub 2018 Jan 5. |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D010149 | Pain, Postoperative |
| D059265 | Visceral Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D009461 | Neurologic Manifestations |
| D059226 | Nociceptive Pain |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D004837 | Epinephrine |
| D020927 | Dexmedetomidine |
| D007649 | Ketamine |
| D017409 | Sufentanil |
| D008012 | Lidocaine |
| D008787 | Metoclopramide |
| D013847 | Thiethylperazine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D000083 | Acetanilides |
| D001549 | Benzamides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D010647 | Phenyl Ethers |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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