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

Overview

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.

Full Title of Study: “Ultrasound Guided Erector Spinae Block Using a Combination of Bupivacaine and Dexmedetomidine Versus Bupivacaine and Magnesium Sulfate for Postoperative Analgesia in Lumbar Spine Surgery”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: January 20, 2023

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.

Interventions

• 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).
• 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.

Arms, Groups and Cohorts

• 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
• 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

Clinical Trial Outcome Measures

Primary Measures

• Measurement of the duration of postoperative analgesia
  • Time Frame: 12 hours
  • 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
• Dose of postoperative nalbuphine
  • Time Frame: 12 hours
  • Total dose of postoperative nalbuphine will be measured depending on the visual analogue scale

Secondary Measures

• Patient satisfaction
  • Time Frame: 48 hours
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Ain Shams University
• Provider of Information About this Clinical Study
  • Principal Investigator: Sameh Refaat, Lecturer of anesthesia – Ain Shams University