Morbid Obesity Clinical Trial
Official title:
Analgesic Efficacy of Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery; a Randomized Controlled Study
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.
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.
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