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

NCT04302129 — Not applicable, Unknown, 30 participants, Mohamed Elsayed

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

Registry	NCT04302129, acronym US ESP block
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	30 (Estimated)
Sponsor	Mohamed Elsayed (Other); collaborators: University of Alexandria
Conditions	Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia
Interventions	Erector spinae plane block, Multimodal analgesia (Procedure, drug)
Dates	start 2020-01-04, primary completion 2020-04-01 (estimated), completion 2020-04-01 (estimated), first posted 2020-03-10, last updated 2020-03-17
Locations	1 site in Egypt

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
ultrasound guided erector spinae block and general anaesthesia	Experimental	Procedure: Erector spinae plane block	Ultrasound guided erector spine plane block is done after general anaesthesia and prone positioning
Multimodal analgesia with general anaesthesia	Active comparator	Drug: Multimodal analgesia	Multimodal analgesia given with general anaesthesia in form of ketorolac and paracetamol

Erector spinae plane block (Procedure): 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.
Multimodal analgesia (Drug): Ketorolac 0.75 mg/ Kg and paracetamol 10 mg/ Kg intravenously

+Outcome measures

Primary outcomes

Anaesthetic requirements: [the surgery period]: based on entropy monitoring and haemodynamic parameters.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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.

+Locations (1)

Facility	City	Country	Status
Alexandria faculty of medicine	Alexandria	Egypt