Clinical trial NCT03798522: Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery
Official title: Analgesic Efficacy of Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery; a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Morbid Obesity
Visceral Pain
Keywords: ultrasound guided regional blocks
laparoscopic surgery
erector spinae plane block
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * erector spinae plane block group (ESPB)
* general anesthesia group (GA)
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The duration of analgesic effect in minutes
timeFrame: 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 outcomes:
measure: mean arterial blood pressure changes
timeFrame: intraoperative and post extubation in the 1st hour
measure: Nalbuphine consumption
timeFrame: total dose given post operatively up to 1 hour postoperatively
measure: visual analogue scale (VAS) for assessment of postoperative pain
timeFrame: at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery
measure: Block failure rate
timeFrame: in the first hour postoperatively
measure: Resumption of peristalsis
timeFrame: postoperatively up to 48 hours postoperatively
measure: incidence of adverse effects
timeFrame: postoperative up to 48 hours
measure: Incidence of shoulder pain
timeFrame: postoperativey up to 24 hours
measure: length of hospital stay
timeFrame: postoperative up to 28 days postoperatively
measure: heart rate
timeFrame: intraoperatively and throughout one hour postextubation
measure: Failure rate of the ESP block
timeFrame: in the first hour postoperatively
Other outcomes:
measure: demographic data
timeFrame: during 30 minutes preoperatively
measure: duration of surgery
timeFrame: from skin incision up to skin closure
measure: weight
timeFrame: during 30 minutes preoperatively
measure: height
timeFrame: during 30 minutes preoperatively
measure: body mass index (BMI)
timeFrame: uring 30 minutes preoperatively
Locations:
city: Giza
country: Egypt
facility: Hany Mohammed El-Hadi Shoukat Mohammed
Study officials:
References: