Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery

Study Overview
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Brief Summary
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bilateral continuous erector spinae plane blockade may represent a valuable alternatives to thoracіc epidurals analgaesіa in treatment of thoracic neuropathic pain. There were 3 cases reported in 2017 suggested that the erector spinae plane block provides visceral abdominal analgesia in bariatric surgery and at end of the report they recommended further clinical investigation. The investigators hypothesіzed that performing the erector spinae plane (ESP) block at T7 would provide effective abdominal analgaesіa іn patients undergone laparoscopic bariatric surgery. The investigators aimed to compare the analgesic effect of erector spinae plane block and opioid based general anesthesia for laparoscopic bariatric surgeries.

Detailed Description
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The investigators hypothesized that, erector spinae plane block will provide good analgesia for patients undergoing laparoscopic bariatric surgery with less complication compared to opioid based general anesthesia. The visual analogue scale (VAS) will be explained clearly to all participants before conduction of anesthesia. All the drugs will be calculated according to the ideal body weight (IBW).A low-frequency (2-5 MHz) curved array ultrasound probe (Mindray®, China) will be used. In the 1st group: bilateral ultrasound-guided erector spinae plane block will be performed under complete aseptic conditions in the lateral position at T7 vertebrae and before induction of general anesthesia. An 8-cm echogenic 22-G block needle will be inserted in-plane. A total of 20 ml of local anesthetic solution (20 ml bupivacaine (Sunnypivacaine, Sunny pharmaceutical, Egypt) 0.25%) will then be injected into the erector spinae plane. This procedure will be repeated on the contralateral side taking care not to exceed the maximum recommended doses (2 mg/kg of IBW for bupivacaine). In the 2nd group: the investigator will give intravenous nalbuphine in a dose of 2mg /kg according to ideal body weight after induction of general anesthesia. All participants will be given 1 gram of intravenous paracetamol (15 mg/Kg), together with 4 mg ondansetron 10 min prior to the end of surgery for postoperative nausea and vomiting prophylaxis. Intraoperatively, any increase in heart rate and/or arterial blood pressure 10 min after intubation by more than 20% of baseline values in response to surgical stimulus or thereafter throughout the whole operation will be managed by intravenous administration of fentanyl 0.5 µg/Kg. VAS score will be assessed 30 min after extubation and when the VAS score exceeded 4/10, rescue analgesia in the form of IV nalbuphine 5 mg will be administered. Another dose of rescue analgesia can be given in the post anesthesia care unit (PACU) if the VAS still more than 4 after 60 min of extubation. If still high, Ketorolac 60 mg will be given by intravenous infusion.

Official Title
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Analgesic Efficacy of Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery; a Randomized Controlled Study

Conditions
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Bariatric Surgery Candidate, Morbid Obesity, Visceral Pain

Intervention / Treatment
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* Procedure: bilateral ultrasound guided erector spinae plane block
* Drug: Nalbuphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age >18 <60 Obese patients 40˂ Body mass index(BMI) ˂50 Both sexes American Society of Anesthesiologists(ASA) physical status classes II and III Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB)surgeries Exclusion Criteria: Refusal of regional block Patients with neurological, psychological disorders or those lacking cooperation Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion. Patients with bleeding disorders defined as (INR >2) and/ or (platelet count <100,000/µL) Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement. Patients who are allergic to amide local anesthetics. Cases converted to open surgery will also be excluded from the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: erector spinae plane block group (ESPB) general anesthesia group (GA)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: erector spinae plane block group (ESPB) n=14<br>Bilateral ultrasound guided erector spinae plane block will be performed in the lateral position at T7 vertebrae and before induction of GA. 20 ml of local anesthetic solution (20 ml bupivacaine (Sunnypivacaine, Sunny pharmaceutical, Egypt) 0.25%) will be injected in-plane into the ESP. This procedure will be repeated on the other side taking care not to exceed the maximum recommended doses (2 mg/kg of IBW for bupivacaine) and then GA will be conducted . | Procedure: bilateral ultrasound guided erector spinae plane block<br>* ESPB on both sides at T7 before GA<br>* Other names: ESPB;|
| Active Comparator: general anesthesia group (GA) n= 14<br>these patients will receive iv nalbuphine in dose of 2mg /kg according to ideal body weight after induction of GA | Drug: Nalbuphine<br>* in nalbuphine for analgesia after GA<br>* Other names: GA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of analgesic effect in minutes | The duration of analgesic effect is indicated by the 1st analgesic requisite after measurement of VAS | defined as the time n minutes between finishing the block technique in ESPB group or after administration of nalbuphine in GA-group, and the request of first dose of postoperative analgesics) when VAS is more than 4 during the 1st 8 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial blood pressure changes | mean arterial blood pressure will be assessed and measured in mmHg non invasively | intraoperative and post extubation in the 1st hour | 
| Nalbuphine consumption | in mg | total dose given post operatively up to 1 hour postoperatively | 
| visual analogue scale (VAS) for assessment of postoperative pain | in numbers, normal scale ranges from 0 to 10 with 0 means no pain and 10 means worst pain imaginable. if VAS score exceeded 4/10; this will be considered insufficient analgesia and participant will be given rescue analgesia | at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery | 
| Block failure rate | patient required more than two 5mg doses of nalbuphine | in the first hour postoperatively | 
| Resumption of peristalsis | in hours | postoperatively up to 48 hours postoperatively | 
| incidence of adverse effects | postoperative nausea and vomiting, urinary retention, hematoma formation, local anesthetic toxicity and need of postoperative ICU or mechanical ventilation | postoperative up to 48 hours | 
| Incidence of shoulder pain | percent | postoperativey up to 24 hours | 
| length of hospital stay | in days | postoperative up to 28 days postoperatively | 
| heart rate | heart rate in beat per minute will be measured | intraoperatively and throughout one hour postextubation | 
| Failure rate of the ESP block | the block will be considered a failed block if the patient required more than two 5mg doses of nalbuphine | in the first hour postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound guided regional blocks, laparoscopic surgery, erector spinae plane block