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

M

Mohamed Elsayed

Status

Unknown

Conditions

Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia

Treatments

Drug: Multimodal analgesia
Procedure: Erector spinae plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT04302129
operative lumbar spine pain

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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