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

NCT03798522 | Completed

• 1 other identifier: N-42-2018
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Morbid Obesity; Visceral Pain

Keywords

ultrasound guided regional blocks; laparoscopic surgery; erector spinae plane block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• mean arterial blood pressure changes

  intraoperative and post extubation in the 1st hour

• Nalbuphine consumption

  total dose given post operatively up to 1 hour postoperatively

• visual analogue scale (VAS) for assessment of postoperative pain

  at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery

• Block failure rate

  in the first hour postoperatively

• Resumption of peristalsis

  postoperatively up to 48 hours postoperatively

Other Outcomes (5)

• demographic data

  during 30 minutes preoperatively

• duration of surgery

  from skin incision up to skin closure

• weight

  during 30 minutes preoperatively

Study Arms (2)

erector spinae plane block group (ESPB) n=14

EXPERIMENTAL

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 .

Procedure: bilateral ultrasound guided erector spinae plane block

general anesthesia group (GA) n= 14

ACTIVE COMPARATOR

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

Drug: Nalbuphine

Interventions

bilateral ultrasound guided erector spinae plane block PROCEDURE

ESPB on both sides at T7 before GA

Also known as: ESPB

erector spinae plane block group (ESPB) n=14

Nalbuphine DRUG

in nalbuphine for analgesia after GA

Also known as: GA

general anesthesia group (GA) n= 14

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hany Mohammed El-Hadi Shoukat Mohammed

Giza, 12211, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid; Visceral Pain

Interventions

Nalbuphine

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nociceptive Pain; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia, pain management and surgical ICU

Model Details: * erector spinae plane block group (ESPB) * general anesthesia group (GA)

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 10, 2019
• Study Start: February 1, 2019
• Primary Completion: August 30, 2019
• Study Completion: September 30, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 9 months
• Access Criteria: Researchgate.gov

Locations

EG (1)