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Clinical Trials/NCT04302129
NCT04302129
Unknown
Not Applicable

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

Mohamed Elsayed1 site in 1 country30 target enrollmentJanuary 4, 2020

Overview

Phase
Not Applicable
Intervention
Erector spinae plane block
Conditions
Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia
Sponsor
Mohamed Elsayed
Enrollment
30
Locations
1
Primary Endpoint
Anaesthetic requirements:
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 4, 2020
End Date
April 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mohamed Elsayed
Responsible Party
Sponsor Investigator
Principal Investigator

Mohamed Elsayed

doctor

University of Alexandria

Eligibility Criteria

Inclusion Criteria

  • patients undergoing lumbar spine surgery

Exclusion Criteria

  • Coagulation disorders.
  • BMI \> 30 or \< 18.
  • Patients with surgical site infection.
  • Patients with unstable spine integrity like fractures or scoliosis.
  • Hypertensive ,cardiac and diabetic patients.

Arms & Interventions

ultrasound guided erector spinae block and general anaesthesia

Ultrasound guided erector spine plane block is done after general anaesthesia and prone positioning

Intervention: Erector spinae plane block

Multimodal analgesia with general anaesthesia

Multimodal analgesia given with general anaesthesia in form of ketorolac and paracetamol

Intervention: Multimodal analgesia

Outcomes

Primary Outcomes

Anaesthetic requirements:

Time Frame: the surgery period

based on entropy monitoring and haemodynamic parameters.

Study Sites (1)

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