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

NCT ID: NCT04302129

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-04

Study Completion Date

2020-04-30

Brief Summary

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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

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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.

Conditions

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Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
closed envelope method

Study Groups

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ultrasound guided erector spinae block and general anaesthesia

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

Group Type EXPERIMENTAL

Erector spinae plane block

Intervention Type 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 with general anaesthesia

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

Group Type ACTIVE_COMPARATOR

Multimodal analgesia

Intervention Type DRUG

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

Interventions

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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.

Intervention Type PROCEDURE

Multimodal analgesia

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alexandria

OTHER

Sponsor Role collaborator

Mohamed Elsayed

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Elsayed

doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Alexandria faculty of medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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operative lumbar spine pain

Identifier Type: -

Identifier Source: org_study_id

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