Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries .

Study Overview
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Brief Summary
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The purpose of this study is to compare addition of dexamethasone to bupivacaine versus bupivacaine alone for trans-incisional bilateral paravertebral block for postoperative analgesia in elective lumbar spine surgeries.

Official Title
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Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries, a Randomized Clinical Trial.

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Dexamethasone+ Bupivacaine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: physical status American Society of Anesthesiologists (ASA) I or II. Exclusion Criteria: refuse to participate have a body mass index (BMI) >30 kg/m2 ASA physical status >II have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological) coagulation abnormalities infection at the injection site tumor in the paravertebral space sepsis Severe chest deformity or scoliosis, due to the possibility of injection into the meninges an allergy or contraindications to the drugs used in the study uncontrolled diabetes patients with active gastric ulceration a history of drug addiction or alcohol abuse a psychiatric illness mental retardation interfering with the evaluation of pain scores.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone + bupivacaine in bilateral TiPVB in lumbar spine surgery<br>Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia | Drug: Dexamethasone+ Bupivacaine<br>* Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.<br>|
| Active Comparator: Bupivacaine in bilateral TiPVB in lumbar spine surgery<br>Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia | Drug: Bupivacaine<br>* Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First time to analgesic requirement | After extubation, an IV PCA system will be connected to the patient (Accufuser Plus® 100 mL: Woo Young Medical Co, Korea). PCA will be prepared with 60 mL of normal saline containing 60 mg of morphine, and the system will be programmed to give a 0.5 mL bolus dose with a lockout interval of 8 min. basal rate will not be present. PCA will be discontinued at 24 h after surgery, and at that time, oral analgesics begin. | 1st 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opioid consumption . | Total opioid consumption in the first 24 h postoperatively . | 1st 24 hour | 
| Visual analogue scale (VAS) | Pain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU and 10, 20, and 30 min and 1, 2, 4, 6, 12, and 24 h thereafter using a visual analog scale (VAS) (ranging from0-10 cm: where 0 = no pain, 10 = worst pain). The patients Will be instructed about the usage of the PCA system and the VAS preoperatively | 1st 24 hours postoperatively |