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OpenTrials
Completed

NCT Number: NCT05590234

Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block

As the posterior lumbosacral spine fixation surgeries are common spine procedures done nowadays due to different causes and as this spine procedure is mostly accompanied with moderate to severe postoperative pain, so it is necessary to find an effective and efficient postoperative analgesia for patients with this surgery.

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Key information

Conditions

Posterior Lumbosacral Spine Fixation Surgeries

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

October 6 university hospital

Giza, 12573, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • elective posterior lumbosacral spine fixation and fusion surgery due to different causes that diagnosed clinically and radiologically including MRI and Plain X ray

Exclusion criteria

  • hypersensitivity to the drugs used in the study [local anesthetics, non-steroidal anti-inflammatory drugs, opioids and the drug under investigation (dexmedetomidine)]
  • patients with any contraindication to regional anesthesia as skin infections at the site of the block
  • history of bleeding disorders or receiving anticoagulant medications

Treatment and study plan

Dexmedetomidine Injection

Drug

1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%

Bupivacaine 0.25% Injectable Solution

Drug

20 ml of bupivacaine 0.25%,

normal saline

Drug

20 ml of normal saline 0.9%.

Primary outcomes

  1. Postoperative visual analogue scale (VAS)

    Time frame: the first 24 hours postoperative

    The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.

  2. Amount of post operative opioid consumption for the first 24 hours

    Time frame: the first 24 hours postoperative

    Amount of total opioid consumption for 24 hours postoperative

Secondary outcomes

  1. Postoperative visual analogue scale (VAS)

    Time frame: the second 24 hour postoperative

    The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.

  2. Amount of post operative opioid consumption for the second 24 hours

    Time frame: the second 24 hour postoperative

    Amount of total opioid consumption for the second 24 hours postoperative

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block Versus Bupivacaine Alone for Postoperative Pain Control of Posterior Lumbosacral Spine Fixation Surgeries

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2022
Registry last updated
Jul 21, 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.