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| Name | Class |
|---|---|
| University of Alexandria | OTHER |
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Ultrasound guided erector spinae plain block combined with general anaesthesia versus conventional general anaesthesia in lumbar spine surgery, it's hypothesized that combined regional anaesthesia with general anaesthesia in lumbar spine surgery may reduce the anaesthetic requirements, aid in controlled hypotension and improve the perioperative pain management.
Primary outcomes:
• Anaesthetic requirements: based on entropy monitoring(state and response entropy monitoring and the difference as a measure for adequacy of analgesia) and haemodynamic parameters ( heart rate and mean arterial blood pressure) at the following time intervals: before induction, after induction, after giving either ESP block or multimodal analgesia and starting surgical stimulus, at 30 min intervals, at end of anaesthesia, at eye opening.
Secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultrasound guided erector spinae block and general anaesthesia | Experimental | Ultrasound guided erector spine plane block is done after general anaesthesia and prone positioning |
|
| Multimodal analgesia with general anaesthesia | Active Comparator | Multimodal analgesia given with general anaesthesia in form of ketorolac and paracetamol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector spinae plane block | Procedure | 20 ml local anaesthetic are injected bilaterally on each side of the surgical incision underneath the erector spinae muscle where the dorsal rami pass around the bases of the transverse processes. |
| Measure | Description | Time Frame |
|---|---|---|
| Anaesthetic requirements: | based on entropy monitoring and haemodynamic parameters. | the surgery period |
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Inclusion Criteria:
patients undergoing lumbar spine surgery
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria faculty of medicine | Alexandria | Egypt |
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After May 2020
Anaesthetic requirements, Haemodynamic parameters, entropy monitoring, perioperative pain evaluation
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 2, 2020 | |
| Reset | May 14, 2020 | |
| Release | May 28, 2020 |
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closed envelope method
| Multimodal analgesia | Drug | Ketorolac 0.75 mg/ Kg and paracetamol 10 mg/ Kg intravenously |
|
| Reset | Jun 9, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 2, 2020 | May 14, 2020 | |||
| May 28, 2020 | Jun 9, 2020 |