Intraoperative Retrolaminar Block as Opioid Free Anesthesia After Posterior Lumber Spine Discectomy

Study Overview
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Brief Summary
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Opioid-free intraoperative protocols have been successfully used in specific surgical populations with equal or superior results to classic general anesthetic approaches. In instances where opioid-free anesthesia may not be entirely feasible, there exists a continually growing body of evidence that the modern anesthesiologist has a potent pharmacologic and regional anesthetic arsenal that can reduce the amount of opioids required to effectively treat pain. Retrolaminar block is considered a new, easy and simple technique with decreasing incidence of complications such as hypotension, pleural and nerve injury. Its efficacy had been investigated in trauma patients

Detailed Description
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Null hypothesis: Intraoperative retrolaminar block will not produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy. Alternative hypothesis: Intraoperative retrolaminar block will produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.

Official Title
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Intraoperative Retrolaminar Block as Opioid Free Anesthesia and Enhanced Recovery After Posterior Lumber Spine Discectomy: A Randomized Controlled Study

Conditions
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Opioid Free Anesthesia

Intervention / Treatment
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* Procedure: Standard analgesia (paracetamol +fentanyl)
* Procedure: Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent from the patient. Age: 21-60 years old. Sex: both sex (males and females). American Society of Anesthesiologist Physical status: ASA 1& II. Body Mass Index (BMI) = (25-30 kg/m2). Type of operation: elective posterior Lumbar discectomy from L3 to L5 disc space. Exclusion Criteria: Altered mental state. Patients with known history of allergy to study drugs. Advanced hepatic, renal, cardiovascular, and respiratory diseases. Patients with chronic pain. Patients receiving anticoagulants. Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard analgesia (paracetamol +fentanyl)<br>Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv | Procedure: Standard analgesia (paracetamol +fentanyl)<br>* Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv<br>|
| Active Comparator: Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone<br>Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina. | Procedure: Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone<br>* Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recovery time | The recovery time (time from discontinuation of isoflurane to first response to verbal command) will be recorded, then the patient will be transferred to the post anesthesia care unite (PACU) on standard monitors. | up to 1 hour postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | pain intensity measured using visual analogue scale from 0= no pain to 10= worst pain | up to 24 hours postoperative |