Erector Spinae Block Using a Dexmedetomidine Versus Magnesium Sulfate as an Adjuvant to Bupivacaine

NCT ID: NCT05694897

Last Updated: 2023-02-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-30

Study Completion Date

2023-02-01

Brief Summary

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This prospective parallel group randomized study will be conducted over 52 adult participants between 20 and 60 years ASA (American Association of Anesthesiologists) I and II undergoing lumbar spine surgery. The participants will be randomly allocated into 2 groups. Group BM (Bupivacaine + magnesium sulfate) will receive bilateral erector spinae block using bupivacaine and magnesium sulfate after induction of general anesthesia, while group BD (Bupivacaine + dexmedetomidine) will receive bilateral erector spinae block using bupivacaine and dexmedetomidine after induction of general anesthesia. Hemodynamic changes will be monitored intraoperatively, and postoperative pain will be assessed using the visual analogue scale in order to assess the need for postoperative analgesia.

Detailed Description

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This prospective parallel group randomized study will be conducted over 52 adult participants between 20 and 60 years ASA (American Association of Anesthesiologists) I and II undergoing lumbar spine surgery. The participants will be randomly allocated into 2 groups.

General anesthesia will be induced using propofol 1-2mg/kg, fentanyl 2ug/kg, and atracurium 0.5mg/kg.

Both groups will receive bilateral erector spinae block Group BM will receive bilateral erector spinae block .A technique that will be performed ultrasound guided to identify the transverse process of T10, and an 18G (gauge) needle will be introduced in plane deep to the erector spinae muscle after which a combination of 20ml bupivacaine 0.25% and 2.5 ml magnesium sulfate.

While group BD will receive the same block with the with 20ml bupivacaine 0.25% and dexmedetomidine 1ug/kg.

Hemodynamic changes will be monitored intraoperatively, for detection of any variations.

Postoperative pain will be assessed every 2 hours following the surgery using the visual analog scale in order to assess the need for postoperative analgesia.

Analgesia will be given in the form of nalbuphine 10mg when the visual analog scale is above 4.

Patient satisfaction will be measured by a scale from 1-10 the next day. Any complications will be recorded.

Conditions

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Postoperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Erector spinae block using a combination of bupivacaine and magnesium sulfate

Ultrasound guided erector spinae block at the level of T10 using a combination of 20 ml bupivacaine 0.25% and 3.75ml magnesium sulfate for treatment of postoperative pain

Group Type ACTIVE_COMPARATOR

Erector spinae block using bupivacaine 0.25% and magnesium sulfate

Intervention Type PROCEDURE

After induction of general anesthesia the patients will be flipped to the prone position and ESP block was performed using, a high frequency linear ultrasound probe placed longitudinally 2 to 3 cm lateral to the 10th thoracic vertebrae, and the trapezius and erector Spinae muscles identified.

An 18-G Tuohy needle passed along the plane of the transducer until its tip hit the transverse process of T10; the needle was then withdrawn slightly.

Total volume of 25 ml was injected including 20 mL 0.25% bupivacaine plus 3.75 ml NS and 125 mg MgSO4 (1.25ml).

Erector spinae block using a combination of bupivacaine and dexmedetomidine

Ultrasound guided erector spinae block at the level of T10 using a combination of 20 ml bupivacaine 0.25% and 1ug/kg dexmedetomidine for treatment of postoperative pain

Group Type ACTIVE_COMPARATOR

Erector spinae block using bupivacaine and dememdetomidine

Intervention Type PROCEDURE

After induction of general anesthesia the patients will be flipped to the prone position and ESP block was performed using, a high frequency linear ultrasound probe placed longitudinally 2 to 3 cm lateral to the 10th thoracic vertebrae, and the trapezius and erector Spinae muscles identified.

An 18-G Tuohy needle passed along the plane of the transducer until its tip hit the transverse process of T10; the needle was then withdrawn slightly.

Total volume of 25 ml was injected including 20 mL 0.25% bupivacaine plus dexmedetomidine 1ug/kg.

Interventions

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Erector spinae block using bupivacaine 0.25% and magnesium sulfate

After induction of general anesthesia the patients will be flipped to the prone position and ESP block was performed using, a high frequency linear ultrasound probe placed longitudinally 2 to 3 cm lateral to the 10th thoracic vertebrae, and the trapezius and erector Spinae muscles identified.

An 18-G Tuohy needle passed along the plane of the transducer until its tip hit the transverse process of T10; the needle was then withdrawn slightly.

Total volume of 25 ml was injected including 20 mL 0.25% bupivacaine plus 3.75 ml NS and 125 mg MgSO4 (1.25ml).

Intervention Type PROCEDURE

Erector spinae block using bupivacaine and dememdetomidine

After induction of general anesthesia the patients will be flipped to the prone position and ESP block was performed using, a high frequency linear ultrasound probe placed longitudinally 2 to 3 cm lateral to the 10th thoracic vertebrae, and the trapezius and erector Spinae muscles identified.

An 18-G Tuohy needle passed along the plane of the transducer until its tip hit the transverse process of T10; the needle was then withdrawn slightly.

Total volume of 25 ml was injected including 20 mL 0.25% bupivacaine plus dexmedetomidine 1ug/kg.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA 1, and 2

Exclusion Criteria

* Patient refusal
* Spine deformities
* Coagulopathies
* Infection at the site of surgery
* Body weight above 100kg
* Known allergy to used drugs
* Psychiatric illness
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Refaat

Lecturer of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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M d 538/2020

Identifier Type: -

Identifier Source: org_study_id

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