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

NCT05694897 | Completed

• 1 other identifier: M d 538/2020
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (2)

• Measurement of the duration of postoperative analgesia

  Postoperative analgesia duration will be assessed using the visual analogue scale which is from 0-10 were 0 means no pain and 10 is the worst pain

  12 hours

• Dose of postoperative nalbuphine

  Total dose of postoperative nalbuphine will be measured depending on the visual analogue scale

  12 hours

Secondary Outcomes (1)

• Patient satisfaction

  48 hours

Study Arms (2)

Erector spinae block using a combination of bupivacaine and magnesium sulfate

ACTIVE COMPARATOR

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

Procedure: Erector spinae block using bupivacaine 0.25% and magnesium sulfate

Erector spinae block using a combination of bupivacaine and dexmedetomidine

ACTIVE COMPARATOR

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

Procedure: Erector spinae block using bupivacaine and dememdetomidine

Interventions

Erector spinae block using bupivacaine 0.25% and magnesium sulfate 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 magnesium sulfate

Erector spinae block using bupivacaine and dememdetomidine 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.

Erector spinae block using a combination of bupivacaine and dexmedetomidine

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA 1, and 2

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, 11728, Egypt

Location

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: January 23, 2023
• Study Start: July 30, 2021
• Primary Completion: January 20, 2023
• Study Completion: February 1, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

EG (1)