Hany Mohammed El-Hadi Shoukat Mohammed
Giza, 12211, Egypt
NCT Number: NCT03798522
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Giza, 12211, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ESPB on both sides at T7 before GA
Other names: ESPB
in nalbuphine for analgesia after GA
Other names: GA
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
Time frame: intraoperative and post extubation in the 1st hour
mean arterial blood pressure will be assessed and measured in mmHg non invasively
Time frame: total dose given post operatively up to 1 hour postoperatively
in mg
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
Time frame: in the first hour postoperatively
patient required more than two 5mg doses of nalbuphine
Time frame: postoperatively up to 48 hours postoperatively
in hours
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
Time frame: postoperativey up to 24 hours
percent
Time frame: postoperative up to 28 days postoperatively
in days
Time frame: intraoperatively and throughout one hour postextubation
heart rate in beat per minute will be measured
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
Time frame: during 30 minutes preoperatively
age, sex, ASA class, co-morbidities
Time frame: from skin incision up to skin closure
in minutes
Time frame: during 30 minutes preoperatively
kilograms
Time frame: during 30 minutes preoperatively
meter
Time frame: uring 30 minutes preoperatively
weight in kilograms divided by square height in meter
Cairo University
Other
Analgesic Efficacy of Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery; a Randomized Controlled Study
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