Dexmedetomidine Versus Fentanyl Plus Bupivacaine for Epidural Analgesia With General Anesthesia for Lumbar Disc Operations

Study Overview
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Brief Summary
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The purpose of this study is to compare addition of dexmedetomidine or fentanyl to bupivacaine for epidural analgesia in combination with general anesthesia in elective lumbar spine operations as regard hemodynamic stability, postoperative pain control and adverse effects.

Official Title
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Adding Dexmedetomidine Versus Fentanyl to Bupivacaine for Epidural Analgesia in Combination With General Anesthesia for Elective Lumbar Disc Operations: Prospective, Randomized Double-blinded Study

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Fentanyl
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physical status American Society of Anesthesiologist (ASA) I or II. First time elective lumbar dicsectomy or laminectomy Exclusion Criteria: Patients who refuse to participate Body mass index (BMI) > 30 Need an emergency lumbar disc operation ASA physical status > II Major illnesses (e.g. cardiac, respiratory, renal, liver) Coagulation abnormalities Hypovolemia History of increased intracranial pressure Convulsions Spinal stenosis Infection at needle insertion site Other contraindications to epidural procedure Allergy or contraindications to the drugs used in the study History of addiction or alcohol abuse Psychiatric illness or mental retardation

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: Group BF<br>Bupivacaine plus Fentanyl | Drug: Bupivacaine<br>* patients will receive combined general anesthesia / epidural analgesia with 15 ml bupivacaine 0.20%<br>* Other names: Local anesthetic;Drug: Fentanyl<br>* Plus 50 µg fentanyl<br>* Other names: Opioid;|
| Active Comparator: Group BD<br>Bupivacaine plus Dexmedetomidine | Drug: Bupivacaine<br>* patients will receive combined general anesthesia / epidural analgesia with 15 ml bupivacaine 0.20%<br>* Other names: Local anesthetic;Drug: Dexmedetomidine<br>* Plus 50 µg dexmedetomidine<br>* Other names: alpha 2 sympathomimetic;|

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 intravenous patient-controlled analgesia system, will be connected to the patient (Accufuser Plus® 100 ml, Woo Young Medical Co, Korea) will be prepared with 60 ml normal saline containing 60 mg morphine, it will be programmed to give and 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first Bolus will be estimated considering extubation time is the zero time. | First 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opioid consumption | Total morphine consumption per twenty four hours will be estimated | First 24 hours postoperatively | 
| 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, 30 minutes, 1 h, 2h, 4, 6, 8, 10, 12, 16 and 24 hr thereafter using visual analogue scale (VAS) (0-10 cm: 0 = no pain, 10 = the worst pain possible). The patients will be instructed about usage of VAS preoperatively | First 24 hours postoperatively |