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

Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia Clinical Trial

— US ESP block  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04302129
• Other study ID #: operative lumbar spine pain
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2020
• Est. completion date: April 2020

Study information

• Verified date: March 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia

Intervention

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.

Drug:
• Multimodal analgesia
Ketorolac 0.75 mg/ Kg and paracetamol 10 mg/ Kg intravenously

Locations

Country	Name	City	State
Egypt	Alexandria faculty of medicine	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Mohamed Elsayed	University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anaesthetic requirements:	based on entropy monitoring and haemodynamic parameters.	the surgery period