Ultrasound Guided Erector Spinae Plane Block Combined With General Anaesthesia Versus Conventional General Anaesthesia in Lumbar Spine Surgery

Not Applicable

• Conditions: Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia
• Interventions: Drug: Multimodal analgesia; Procedure: Erector spinae plane block

• Registration Number: NCT04302129
• Lead Sponsor: Mohamed Elsayed

Brief Summary

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.

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 Timeline

• Study Start: 2020-01-04
• Status Verified: 2020-03
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-17
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal analgesia with general anaesthesia	Multimodal analgesia	Multimodal analgesia given with general anaesthesia in form of ketorolac and paracetamol
ultrasound guided erector spinae block and general anaesthesia	Erector spinae plane block	Ultrasound guided erector spine plane block is done after general anaesthesia and prone positioning

Primary Outcome Measures

Name	Time	Method
Anaesthetic requirements:	the surgery period	based on entropy monitoring and haemodynamic parameters.

Trial Locations

Locations (1)

Alexandria faculty of medicine; 🇪🇬 Alexandria, Egypt