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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 30, 2019

Detailed Description

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.

Interventions

  • Procedure: bilateral ultrasound guided erector spinae plane block
    • ESPB on both sides at T7 before GA
  • Drug: Nalbuphine
    • in nalbuphine for analgesia after GA

Arms, Groups and Cohorts

  • Experimental: erector spinae plane block group (ESPB) n=14
    • 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 .
  • Active Comparator: general anesthesia group (GA) n= 14
    • these patients will receive iv nalbuphine in dose of 2mg /kg according to ideal body weight after induction of GA

Clinical Trial Outcome Measures

Primary Measures

  • The duration of analgesic effect in minutes
    • Time Frame: 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
    • The duration of analgesic effect is indicated by the 1st analgesic requisite after measurement of VAS

Secondary Measures

  • mean arterial blood pressure changes
    • Time Frame: intraoperative and post extubation in the 1st hour
    • mean arterial blood pressure will be assessed and measured in mmHg non invasively
  • Nalbuphine consumption
    • Time Frame: total dose given post operatively up to 1 hour postoperatively
    • in mg
  • visual analogue scale (VAS) for assessment of postoperative pain
    • Time Frame: at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery
    • 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
  • Block failure rate
    • Time Frame: in the first hour postoperatively
    • patient required more than two 5mg doses of nalbuphine
  • Resumption of peristalsis
    • Time Frame: postoperatively up to 48 hours postoperatively
    • in hours
  • incidence of adverse effects
    • Time Frame: postoperative up to 48 hours
    • postoperative nausea and vomiting, urinary retention, hematoma formation, local anesthetic toxicity and need of postoperative ICU or mechanical ventilation
  • Incidence of shoulder pain
    • Time Frame: postoperativey up to 24 hours
    • percent
  • length of hospital stay
    • Time Frame: postoperative up to 28 days postoperatively
    • in days
  • heart rate
    • Time Frame: intraoperatively and throughout one hour postextubation
    • heart rate in beat per minute will be measured
  • Failure rate of the ESP block
    • Time Frame: in the first hour postoperatively
    • the block will be considered a failed block if the patient required more than two 5mg doses of nalbuphine

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hany Mohammed El-Hadi Shoukat Mohammed, lecturer of anesthesia, pain management and surgical ICU – Cairo University

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