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

The Analgesic Efficacy of Erector Spinae Block in Comparison to Thoracic Epidural Anesthesia in Patients Having Transthoracic Oesophygeal Surgical Procedures

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 .

Study Overview

• Status: Completed
• Conditions: Analgesic Efficacy
• Intervention / Treatment: Device: bilateral erector spinae block; Device: Thoracic epidural anesthesia

Detailed Description

The patients will randomised into 2 groups. There are 2 groups of patients: TEA combined with GA or bilateral erector spinae block combined with G. In TEA group, patients will receive TEA, an epidural catheter will be placed at the T7-8 interspace after 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. A left-sided, double-lumen thoracostomy tube will be inserted and confirmed by bronchofiberoscopy. 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 and a high-frequency linear ultrasound transducer (GE LOGIQe, Wauwatosa, Wisconsin) 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 (EchoStim; Benlan Inc, Oakville, Canada) 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 .

Hemodynamics as heart rate, arterial blood pressure, central venous pressure and oxygen saturation will be monitored intraoperatively. The heart rate and arterial blood pressure will be maintained within 20% of the preoperative values.

At the end of the procedure, in both groups, anesthesia will be discontinued and neuromuscular blockade will be antagonized with neostigmine, intravenous (0.05 mg/kg) and atropine intravenous (0.03 mg/kg) at appropriate doses.

The patients will be transported postoperatively to the intensive care unit. if VAS > 5 , Patient-controlled analgesia using elastomeric pump will be established with IV doses of morphine in the erector group (basal rate about 0.5mg/h to 1 mg/h and bolus dose of 2 mg , 300 mL maximum dose) and epidural analgesia in the TEA group (top up doses of about 4 ml of bupivacaine 0.125% + morphine 20 μg/mL, bolus doses 2 mL to 3 mL, 300 ml maximum dose). The patients will be monitored in the postanaesthesia care unit (PACU)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Ain Shams U

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

36-65 years old oesophageal procedures ASA I,II

-

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bilateral erector spinae block; 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; 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 .
Sham Comparator: Thoracic epidural anesthesia; 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; 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	minor complications (hypotension, vomiting, urinary retention and catheter related complications) and major complications (mortality).	24 h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of hospital stay	Recovery time from end of surgery till discharge from hospital	15-17 days

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Nahed Effat, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 2, 2019

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: oesophageal surgeries-epidural-erector block
• Other Study ID Numbers: FMASU R19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: study protocol statistical analysis
• IPD Sharing Time Frame: 6 months
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No