Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia

Study Overview
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Brief Summary
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It was proven that intrathecal opioids are considered as an effective means of pain control in several major surgical interventions including spine surgeries. Intrathecal morphine added to a spinal anesthesia reduces acute pain after spine surgeries but has side effects, including dose dependent respiratory depression, nausea, vomiting, pruritus, and sedation. Ultrasound guided Erector Spinae Plane Block (ESPB) was first described in 2016.Recent case reports suggest a positive effect of ultrasound guided ESPB on pain for multiple indications including lumbar spine fusion and scoliosis surgery, with a very low risk of complications as there are no structures in close proximity at risk of needle injury.

Official Title
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A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia: Ultrasound Guided Erector Spinae Plane Block Versus Intrathecal Morphine

Conditions
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Post Operative Pain

Intervention / Treatment
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* Procedure: Ultrasound Guided Erector Spinae Plane Block
* Drug: Intrathecal morphine
* Other: General anesthesia using intravenous fentanyl (1µg/kg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) 25 to 35 kg/m². American Society of Anesthesiologist (ASA) physical status I or II. Exclusion Criteria: patient's refusal Altered mental status Known allergy to study drugs (bupivacaine or morphine) Local infection at site of puncture. Known case with any pulmonary disease Known case with Obstructive sleep apnea (OSA) Coagulopathy and /or thrombocytopenia Chronic pain Severe hepatic or kidney impairment

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 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: General anesthesia and Ultrasound Guided Erector Spinae Plane Block<br> | Procedure: Ultrasound Guided Erector Spinae Plane Block<br>* General anesthesia and Ultrasound Guided Erector Spinae Plane Block<br>|
| Active Comparator: General anesthesia and intrathecal morphine<br> | Drug: Intrathecal morphine<br>* General anesthesia and intrathecal morphine<br>|
| Other: General anesthesia using intravenous fentanyl (1µg/kg)<br> | Other: General anesthesia using intravenous fentanyl (1µg/kg)<br>* General anesthesia using intravenous fentanyl (1µg/kg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first requested rescue analgesia (Minutes). | Time to first requested rescue analgesia (Minutes). | First 24 hours after surgery. |