Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block

Study Overview
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Brief Summary
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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.

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

Conditions
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Posterior Lumbosacral Spine Fixation Surgeries

Intervention / Treatment
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* Drug: Dexmedetomidine injection
* Drug: Bupivacaine 0.25% Injectable Solution
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine combined with bupivacaine group (DB group)<br>patients received 1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%, | Drug: Dexmedetomidine injection<br>* 1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%<br>Drug: Bupivacaine 0.25% Injectable Solution<br>* 20 ml of bupivacaine 0.25%,<br>|
| Active Comparator: bupivacaine 0.25%,<br>patients received 20 ml of bupivacaine 0.25% | Drug: Bupivacaine 0.25% Injectable Solution<br>* 20 ml of bupivacaine 0.25%,<br>|
| Placebo Comparator: control group (S group)<br>patients received 20 ml of normal saline 0.9%. | Drug: normal saline<br>* 20 ml of normal saline 0.9%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative visual analogue scale (VAS) | The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity. | the first 24 hours postoperative | 
| Amount of post operative opioid consumption for the first 24 hours | Amount of total opioid consumption for 24 hours postoperative | the first 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative visual analogue scale (VAS) | The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity. | the second 24 hour postoperative | 
| Amount of post operative opioid consumption for the second 24 hours | Amount of total opioid consumption for the second 24 hours postoperative | the second 24 hour postoperative |