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

January 11, 2020 updated by: Hany Mohammed El-Hadi Shoukat Mohammed, Cairo University

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Giza, Egypt, 12211
        • Hany Mohammed El-Hadi Shoukat Mohammed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 .
ESPB on both sides at T7 before GA
Other Names:
  • ESPB
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
in nalbuphine for analgesia after GA
Other Names:
  • GA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
intraoperative and post extubation in the 1st hour
Nalbuphine consumption
Time Frame: total dose given post operatively up to 1 hour postoperatively
in mg
total dose given post operatively up to 1 hour postoperatively
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
at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery
Block failure rate
Time Frame: in the first hour postoperatively
patient required more than two 5mg doses of nalbuphine
in the first hour postoperatively
Resumption of peristalsis
Time Frame: postoperatively up to 48 hours postoperatively
in hours
postoperatively up to 48 hours postoperatively
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
postoperative up to 48 hours
Incidence of shoulder pain
Time Frame: postoperativey up to 24 hours
percent
postoperativey up to 24 hours
length of hospital stay
Time Frame: postoperative up to 28 days postoperatively
in days
postoperative up to 28 days postoperatively
heart rate
Time Frame: intraoperatively and throughout one hour postextubation
heart rate in beat per minute will be measured
intraoperatively and throughout one hour postextubation
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
in the first hour postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
demographic data
Time Frame: during 30 minutes preoperatively
age, sex, ASA class, co-morbidities
during 30 minutes preoperatively
duration of surgery
Time Frame: from skin incision up to skin closure
in minutes
from skin incision up to skin closure
weight
Time Frame: during 30 minutes preoperatively
kilograms
during 30 minutes preoperatively
height
Time Frame: during 30 minutes preoperatively
meter
during 30 minutes preoperatively
body mass index (BMI)
Time Frame: uring 30 minutes preoperatively
weight in kilograms divided by square height in meter
uring 30 minutes preoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

December 27, 2018

First Submitted That Met QC Criteria

January 8, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 11, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

yes

IPD Sharing Time Frame

9 months

IPD Sharing Access Criteria

Researchgate.gov

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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