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

Primary Purpose

Bariatric Surgery Candidate, Morbid Obesity, Visceral Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
bilateral ultrasound guided erector spinae plane block
Nalbuphine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bariatric Surgery Candidate focused on measuring ultrasound guided regional blocks, laparoscopic surgery, erector spinae plane block

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hany Mohammed El-Hadi Shoukat Mohammed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

erector spinae plane block group (ESPB) n=14

general anesthesia group (GA) n= 14

Arm Description

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 .

these patients will receive iv nalbuphine in dose of 2mg /kg according to ideal body weight after induction of GA

Outcomes

Primary Outcome Measures

The duration of analgesic effect in minutes
The duration of analgesic effect is indicated by the 1st analgesic requisite after measurement of VAS

Secondary Outcome Measures

mean arterial blood pressure changes
mean arterial blood pressure will be assessed and measured in mmHg non invasively
Nalbuphine consumption
in mg
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
Block failure rate
patient required more than two 5mg doses of nalbuphine
Resumption of peristalsis
in hours
incidence of adverse effects
postoperative nausea and vomiting, urinary retention, hematoma formation, local anesthetic toxicity and need of postoperative ICU or mechanical ventilation
Incidence of shoulder pain
percent
length of hospital stay
in days
heart rate
heart rate in beat per minute will be measured
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

Full Information

First Posted
December 27, 2018
Last Updated
January 11, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03798522
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Morbid Obesity, Visceral Pain
Keywords
ultrasound guided regional blocks, laparoscopic surgery, erector spinae plane block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
erector spinae plane block group (ESPB) general anesthesia group (GA)
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
erector spinae plane block group (ESPB) n=14
Arm Type
Experimental
Arm Description
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 .
Arm Title
general anesthesia group (GA) n= 14
Arm Type
Active Comparator
Arm Description
these patients will receive iv nalbuphine in dose of 2mg /kg according to ideal body weight after induction of GA
Intervention Type
Procedure
Intervention Name(s)
bilateral ultrasound guided erector spinae plane block
Other Intervention Name(s)
ESPB
Intervention Description
ESPB on both sides at T7 before GA
Intervention Type
Drug
Intervention Name(s)
Nalbuphine
Other Intervention Name(s)
GA
Intervention Description
in nalbuphine for analgesia after GA
Primary Outcome Measure Information:
Title
The duration of analgesic effect in minutes
Description
The duration of analgesic effect is indicated by the 1st analgesic requisite after measurement of VAS
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
Secondary Outcome Measure Information:
Title
mean arterial blood pressure changes
Description
mean arterial blood pressure will be assessed and measured in mmHg non invasively
Time Frame
intraoperative and post extubation in the 1st hour
Title
Nalbuphine consumption
Description
in mg
Time Frame
total dose given post operatively up to 1 hour postoperatively
Title
visual analogue scale (VAS) for assessment of postoperative pain
Description
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
at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery
Title
Block failure rate
Description
patient required more than two 5mg doses of nalbuphine
Time Frame
in the first hour postoperatively
Title
Resumption of peristalsis
Description
in hours
Time Frame
postoperatively up to 48 hours postoperatively
Title
incidence of adverse effects
Description
postoperative nausea and vomiting, urinary retention, hematoma formation, local anesthetic toxicity and need of postoperative ICU or mechanical ventilation
Time Frame
postoperative up to 48 hours
Title
Incidence of shoulder pain
Description
percent
Time Frame
postoperativey up to 24 hours
Title
length of hospital stay
Description
in days
Time Frame
postoperative up to 28 days postoperatively
Title
heart rate
Description
heart rate in beat per minute will be measured
Time Frame
intraoperatively and throughout one hour postextubation
Title
Failure rate of the ESP block
Description
the block will be considered a failed block if the patient required more than two 5mg doses of nalbuphine
Time Frame
in the first hour postoperatively
Other Pre-specified Outcome Measures:
Title
demographic data
Description
age, sex, ASA class, co-morbidities
Time Frame
during 30 minutes preoperatively
Title
duration of surgery
Description
in minutes
Time Frame
from skin incision up to skin closure
Title
weight
Description
kilograms
Time Frame
during 30 minutes preoperatively
Title
height
Description
meter
Time Frame
during 30 minutes preoperatively
Title
body mass index (BMI)
Description
weight in kilograms divided by square height in meter
Time Frame
uring 30 minutes preoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hany Mohammed El-Hadi Shoukat Mohammed
City
Giza
ZIP/Postal Code
12211
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
yes
IPD Sharing Time Frame
9 months
IPD Sharing Access Criteria
Researchgate.gov

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

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