The Analgesic Efficacy of Erector Spinae Block in Comparison to Thoracic Epidural Anesthesia in Oesophageal Surgeries

NCT03504371 | Completed

• 1 other identifier: FMASU R19
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

a total of 80 patients age of 36 years old to 65 years old, (ASA) physical status I and II undergoing oesophageal procedures.The patients will randomised using concealed envelope method into 2 groups, allocation of patients to either group will be done by clinician not involved in the study. There are 2 groups of patients: TEA combined with GA (TEA group) or bilateral erector spinae block combined with GA (erector group). . In TEA group, patients will receive TEA where an epidural catheter will be placed at the T7-8 interspace after proper sterilization and positioning of the patient in the sitting position then standard technique of application will be applied, then a test dose consists of 3 ml of 1.5% preservative free lidocaine with 1:200,000 epinephrine will be injected followed by 5-6 ml of bupivacaine 0.25%. Anaesthesia will be standardised In the TEA group, an additional 4-5mL epidural doses of bupivacaine 0.25% will be administered at 1 h intervals. In the second group, patients will receive bilateral ESP block which will be performed as follows. The patient will be placed in a lateral position ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 22-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. A total of 20 mL of 0.25% bupivacaine will be injected then it will be repeated on the other side and preformed in the same way without changing the position of the patient to achieve sensory block T5-T10 .

Conditions

Analgesic Efficacy

Keywords

oesophageal surgeries-epidural-erector block

Outcome Measures

Primary Outcomes (1)

• postoperative complications

  minor complications (hypotension, vomiting, urinary retention and catheter related complications) and major complications (mortality).

  24 h

Secondary Outcomes (1)

• length of hospital stay

  15-17 days

Study Arms (2)

bilateral erector spinae block

ACTIVE COMPARATOR

The patient placed in a lateral position and ultrasound transducer placed 3 cm lateral to the T7 spinous process. Three muscles will be identified: trapezius, rhomboid major, and erector spinae. 8-cm 22-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony shadows of the transverse processes. 20 mL of 0.25% bupivacaine will be injected then it will be repeated on the other side in the same way without changing the position of the patient to achieve sensory block T5-T10 .

Device: bilateral erector spinae block

Thoracic epidural anesthesia

SHAM COMPARATOR

an epidural catheter placed at the T7-8 interspace after proper sterilization and positioning of the patient in the sitting position then standard technique of application will be applied, then a test dose consists of 3 ml of 1.5% preservative free lidocaine will be injected followed by 5-6 ml of bupivacaine 0.25%

Device: Thoracic epidural anesthesia

Interventions

bilateral erector spinae block DEVICE

The patient placed in a lateral position and transducer placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 22-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. 20 mL of 0.25% bupivacaine will be injected then it will be repeated on the other side and preformed in the same way to achieve sensory block T5-T10 .

bilateral erector spinae block

Thoracic epidural anesthesia DEVICE

patients will receive TEA where an epidural catheter will be placed at the T7-8 interspace after proper sterilization and positioning of the patient in the sitting position then standard technique of application will be applied, then a test dose consists of 3 ml of 1.5% preservative free lidocaine with 1:200,000 epinephrine will be injected followed by 5-6 ml of bupivacaine 0.25%.

Thoracic epidural anesthesia

Eligibility Criteria

• Age: 36 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old oesophageal procedures ASA I,II

You may not qualify if:

• cardiac dysfunction Renal or hepatic impairment patient refusal Immune disorders Allergy to local anesthetics neuromuscular disorders

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams U

Cairo, 11566, Egypt

Location

Study Officials

• Nahed Effat

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hoda Shokri

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: February 14, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 2, 2019
• Last Updated: April 4, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months

Locations

EG (1)