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NCT Number: NCT05694897

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

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.

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Key information

Conditions

Postoperative Analgesia

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams university

Cairo, 11728, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. 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

  2. Dose of postoperative nalbuphine

    Time frame: 12 hours

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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2023
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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