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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798522
• Other study ID #: N-42-2018
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Morbid Obesity
• Obesity, Morbid
• Visceral Pain

Intervention

Procedure:
• bilateral ultrasound guided erector spinae plane block
ESPB on both sides at T7 before GA

Drug:
• Nalbuphine
in nalbuphine for analgesia after GA

Locations

Country	Name	City	State
Egypt	Hany Mohammed El-Hadi Shoukat Mohammed	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	demographic data	age, sex, ASA class, co-morbidities	during 30 minutes preoperatively
Other	duration of surgery	in minutes	from skin incision up to skin closure
Other	weight	kilograms	during 30 minutes preoperatively
Other	height	meter	during 30 minutes preoperatively
Other	body mass index (BMI)	weight in kilograms divided by square height in meter	uring 30 minutes preoperatively
Primary	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	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
Secondary	Nalbuphine consumption	in mg	total dose given post operatively up to 1 hour postoperatively
Secondary	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
Secondary	Block failure rate	patient required more than two 5mg doses of nalbuphine	in the first hour postoperatively
Secondary	Resumption of peristalsis	in hours	postoperatively up to 48 hours postoperatively
Secondary	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
Secondary	Incidence of shoulder pain	percent	postoperativey up to 24 hours
Secondary	length of hospital stay	in days	postoperative up to 28 days postoperatively
Secondary	heart rate	heart rate in beat per minute will be measured	intraoperatively and throughout one hour postextubation
Secondary	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