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This is a prospective observational study conducted at the trauma center of Città della Salute e della Scienza of Turin. The aim of the study is to compare two local regional anesthesia techniques in multimodal analgesia for spine fusion: Intrathecal Morphine (IM) and the Erector Spinae Plane Block (ESPB). The effectiveness of these techniques is to be understood in terms of improved intraoperative and postoperative pain management.
Primary outcome:
● Assessment of postoperative pain upon awakening using the NRS score (T0). The secondary outcomes are aimed at investigating whether one technique is more effective than the other in terms of reducing postoperative opioid consumption and therefore improving pain control in the first 24 hours. Any side effects and complications related to the two techniques will also be analyzed.
Patients are enrolled by signing an informed consent form before surgery. At the time of surgery, an anesthesiologist experienced in locoregional techniques performs one of the two techniques (only those who have been specially trained can perform ESPB). A shared multimodal analgesia protocol is followed intraoperatively. In the postoperative period, standard analgesic therapy is set up and in the first 24 hours parameters, pain (NRS), any rescue medications administered and side effects and complications are recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IM: Intrathecal Morphine | Patients treated with IM in association to multimodal analgesia | ||
| ESPB: Erector Spinae Plane Block | Patients treated with ESPB in association to multimodal analgesia |
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| Measure | Description | Time Frame |
|---|---|---|
| NRS score T0 | Postoperative pain upon awakening (T0), measured using the NRS (Numeric rating scale) score. | T0: up to 20 minutes after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| NRS at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours | Postoperative pain measured using the NRS score at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours post surgery | 2 hours, 4 hours, 6 hours, 12 hours, 24 hours post surgery |
| Opioid consumption |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with presenting surgical indication for thoracolumbar spinal fusion with posterior access. The patients enrolled are being treated at the CTO (Trauma and Orthopedic Center) hospital in Turin.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Traumatologico Ortopedico (CTO) - AOU Città della Salute e della Scienza University Hospital | Torino | To | 10126 | Italy |
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Post-operative opioid consumption (morphine milligram) in the first 24 hours.
| Consumption of morphine at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours after surgery |
| Intraoperatory opioid consumption | Opioid consumption during surgery: intraoperatory remifentanil dosage | during the surgery |
| Rescue therapy request | Time after which the first rescue therapy was requested expressed in hours | During the first 24 hours post surgery |
| Sides effects | Incidence of acute side effects attributable to opioid use (excessive sedation, respiratory depression, nausea and vomiting, pruritus, urinary retention, constipation) | First 24 hours after surgery |
| Regional anesthesia complications | Incidence of complications related to subarachnoid puncture or fascial block | Up to first 24 hours after surgery |