Ultrasound Guided Erector Spinae Plane Block Combined With General Anaesthesia Versus Conventional General Anaesthesia in Lumbar Spine Surgery (US ESP block)

ERECTOR SPINAE PLANE BLOCK COMBINED WITH GENERAL ANAESTHESIA VERSUS CONVENTIONAL GENERAL ANAESTHESIA IN LUMBAR SPINE SURGERY

Ultrasound guided erector spinae plain block combined with general anaesthesia versus conventional general anaesthesia in lumbar spine surgery, it's hypothesized that combined regional anaesthesia with general anaesthesia in lumbar spine surgery may reduce the anaesthetic requirements, aid in controlled hypotension and improve the perioperative pain management.

Study Overview

• Status: Unknown
• Conditions: Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia
• Intervention / Treatment: Procedure: Erector spinae plane block; Drug: Multimodal analgesia

Detailed Description

Primary outcomes:

• Anaesthetic requirements: based on entropy monitoring(state and response entropy monitoring and the difference as a measure for adequacy of analgesia) and haemodynamic parameters ( heart rate and mean arterial blood pressure) at the following time intervals: before induction, after induction, after giving either ESP block or multimodal analgesia and starting surgical stimulus, at 30 min intervals, at end of anaesthesia, at eye opening.

Secondary outcomes:

• Stress response measurement based on serum cortisol and blood glucose levels
• Controlled hypotensive anaesthesia: various drugs required and doses given
• Intraoperative and postoperative analgesia.
• Postanaesthesia care unit data concerning recovery.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

patients undergoing lumbar spine surgery

Exclusion Criteria:

• Coagulation disorders.
• BMI > 30 or < 18.5.
• Patients with surgical site infection.
• Patients with unstable spine integrity like fractures or scoliosis.
• Hypertensive ,cardiac and diabetic patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ultrasound guided erector spinae block and general anaesthesia; Ultrasound guided erector spine plane block is done after general anaesthesia and prone positioning	Procedure: Erector spinae plane block; 20 ml local anaesthetic are injected bilaterally on each side of the surgical incision underneath the erector spinae muscle where the dorsal rami pass around the bases of the transverse processes.
Active Comparator: Multimodal analgesia with general anaesthesia; Multimodal analgesia given with general anaesthesia in form of ketorolac and paracetamol	Drug: Multimodal analgesia; Ketorolac 0.75 mg/ Kg and paracetamol 10 mg/ Kg intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anaesthetic requirements:	based on entropy monitoring and haemodynamic parameters.	the surgery period

Collaborators and Investigators

• Sponsor: Mohamed Elsayed
• Collaborators: University of Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2020
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: operative lumbar spine pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After May 2020
• IPD Sharing Access Criteria: Anaesthetic requirements, Haemodynamic parameters, entropy monitoring, perioperative pain evaluation
• 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