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

Not Applicable

Completed

• Conditions: Postoperative Analgesia
• Interventions: Procedure: Erector spinae block using bupivacaine 0.25% and magnesium sulfate; Procedure: Erector spinae block using bupivacaine and dememdetomidine

• Registration Number: NCT05694897
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Study Start: 2021-07-30
• Study First Submitted: 2022-12-24
• Study First Submitted QC: 2023-01-19
• Primary Completion: 2023-01-20
• Study First Posted: 2023-01-23
• Status Verified: 2023-02
• Study Completion: 2023-02-01
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector spinae block using a combination of bupivacaine and magnesium sulfate	Erector spinae block using bupivacaine 0.25% 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
Erector spinae block using a combination of bupivacaine and dexmedetomidine	Erector spinae block using bupivacaine and dememdetomidine	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	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

Trial Locations

Locations (1)

Ain Shams university; 🇪🇬 Cairo, Egypt