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

Postoperative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05694897
• Other study ID #: M d 538/2020
• Status: Completed
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 1, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Analgesia

Intervention

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).
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Dose of postoperative nalbuphine	Total dose of postoperative nalbuphine will be measured depending on the visual analogue scale	12 hours
Secondary	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