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

Ultrasound Guided Erector Spinae Block Using a Combination of Bupivacaine and Dexmedetomidine Versus Bupivacaine and Magnesium Sulfate for Postoperative Analgesia in Lumbar Spine Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Analgesia
• Intervention / Treatment: Procedure: Erector spinae block using bupivacaine 0.25% and magnesium sulfate; Procedure: Erector spinae block using bupivacaine and dememdetomidine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11728
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: 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).
Active Comparator: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction will be measured using the patient satisfaction scale which will be from 1-10 were 1 means no satisfaction and 10 is the best satisfaction	48 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: December 24, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Anesthetics, Local; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Bupivacaine; Magnesium Sulfate
• Other Study ID Numbers: M d 538/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No