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

Official 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

Overview

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.

Detailed 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.

Interventions

• Drug 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).
• Drug 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).
• Drug 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).
• Drug 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.
• Drug 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.
• Drug 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.
• Drug 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.
• Procedure 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
• Procedure Opioid based Anesthesia
  Patients scheduled for laparoscopic sleeve gastrectomy will be anesthetized with opioids and general anesthesia
• Procedure 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.

Primary outcome measures

• 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]

Secondary outcome measures (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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Croatia · 1 center

• University Hospital Dubrava — Zagreb

Publications

• 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. PMID 33417101
• 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. PMID 25756905
• 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. PMID 29077813
• 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. PMID 14627460
• 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. PMID 31785720
• 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. PMID 30810425
• 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. PMID 31609155
• 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. PMID 28263427

Identifiers

NCT: NCT07084753 · 2023- 2301-08

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗