Comparative Study Between ESPB Versus IV Morphine as Postoperative Analgesia After Spine Surgeries .

Study Overview
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Brief Summary
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Postoperative pain is often severe in patients undergoing lumbar surgery. Due to postoperative pain, patients are unwilling to get out of bed at an early stage, which affects their recovery. Erector spinae plane block (ESPB) as a new trunk fascia block technique was proposed in 2016. ESPB has aroused the interest of many nerve block experts. The benefits of ESPB are not yet demonstrated. The specific mechanism is still controversial. The erector spinae block is achieved by injecting the local anesthetic solution (with possible adjuvants) between the erector spinae muscles (iliocostalis, longissimus, spinalis/ from lateral to medial) and the transverse process . The technique is performed under ultrasound guidance.

Official Title
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Comparative Study Between Erector Spinae Plane Block Versus Intravenous Morphine as Postoperative Analgesia After Spine Surgeries .

Conditions
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Discectomy, Vertebral Fractures

Intervention / Treatment
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* Drug: Erector Spinae plane block (plain pubivicaine)
* Drug: Intravenous morphine group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lumbar Disc Prolapse. Fracture Lumbar Vertebrae Exclusion Criteria: Patient refusal. Drug abuse. Patient with significant neurological, psychiatric or neuromuscular disease. Chronic pain on medicine. known allergy to the study medications. Infection at the site of infiltration. Patients with bleeding tendency.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erector Spinae Plane block group<br>(30 patients) will receive bilateral ultrasound guided erector spinae plane block using plain bupivacaine 100 mg diluted to volume using normal saline to achieve 50% concentration ( 50 mg plain pubivicaine in each side ). | Drug: Erector Spinae plane block (plain pubivicaine)<br>* The erector spinae block is achieved by injecting the local anesthetic solution (with possible adjuvants) between the erector spinae muscles (iliocostalis, longissimus, spinalis/ from lateral to medial) and the transverse process . The technique is performed under ultrasound guidance.<br>* Other names: ESPB group;|
| Active Comparator: Intravenous Morphine group<br>(30 patients) will receive 0.1 mg /kg of intravenous morphine diluted to 10 ml volume using saline at the end of the operation. | Drug: Intravenous morphine group<br>* patients will receive 0.1 mg /kg of intravenous morphine diluted to 10 ml volume using saline at the end of the operation.<br>* Other names: Morphine group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesia . | The study will include 60 adult patients undergoing uncomplicated spine surgery under general anesthesia. At the end of operation , Patients will be randomly divided using closed enveloped method into two equal groups. Group 1, (30 patients) will receive bilateral ultrasound guided erector spinae plane block using plain bupivacaine 100 mg diluted to volume using normal saline to achieve 50% concentration ( 50 mg plain pubivicaine in each side ). Group 2, (30 patients) will receive 0.1 mg /kg of intravenous morphine diluted to 10 ml volume using saline at the end of the operation. postoperative pain assessment according to visual analogue scale ( VAS ) within 24 hours after the surgery. 0 - 3 mild pain ( better outcome ) 4 - 6 moderate pain 7 - 10 severe pain > 10 unbearable pain ( worst outcome) | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Avoid side effects of using systemic morphine. | use of intravenous morphine is mostly followed by undesirable side effects such as postoperative nausea and vomiting,urine retention and constipation. so the target of this study is to show that if ESPB is more preferrable to IV morphine as regard both : postoperative anagesia and avoidance of side effects of systemic morphine. patients of morphine group will be asked about having nausea or vomiting after surgery and over 24 hours after the operation. | 24 hours after surgery |