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

NCT04302129 | Unknown DMC

• 1 other identifier: operative lumbar spine pain
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Anaesthetic requirements:

  based on entropy monitoring and haemodynamic parameters.

  the surgery period

Study Arms (2)

ultrasound guided erector spinae block and general anaesthesia

EXPERIMENTAL

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

Procedure: Erector spinae plane block

Multimodal analgesia with general anaesthesia

ACTIVE COMPARATOR

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

Drug: Multimodal analgesia

Interventions

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.

ultrasound guided erector spinae block and general anaesthesia

Multimodal analgesia DRUG

Ketorolac 0.75 mg/ Kg and paracetamol 10 mg/ Kg intravenously

Multimodal analgesia with general anaesthesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing lumbar spine surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Elsayed: lead
• University of Alexandria: collaborator

Study Sites (1)

Alexandria faculty of medicine

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: closed envelope method
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: January 4, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After May 2020
• Access Criteria: Anaesthetic requirements, Haemodynamic parameters, entropy monitoring, perioperative pain evaluation

Locations

EG (1)