Erector Spina Plan Block, Intrathecal Anesthesia, Locoregional Anaesthesia, Multimodal General Anesthesia, Spine Fusion
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
A.O.U. Città della Salute e della Scienza
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>=18 years * Patients with surgical indication for thoracolumbar spinal fusion with posterior access. * ASA I, II, III
Exclusion criteria
* Patient refusal * Emergency surgery * Chronic use (\>12 weeks) of opioids in the preoperative period * Drug addiction * Contraindication to drugs contained in the protocol * Contraindications to performing a subarachnoid puncture or fascial block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS score T0 | T0: up to 20 minutes after surgery | Postoperative pain upon awakening (T0), measured using the NRS (Numeric rating scale) score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | Consumption of morphine at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours after surgery | Post-operative opioid consumption (morphine milligram) in the first 24 hours. |
| Intraoperatory opioid consumption | during the surgery | Opioid consumption during surgery: intraoperatory remifentanil dosage |
| NRS at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours | 2 hours, 4 hours, 6 hours, 12 hours, 24 hours post surgery | Postoperative pain measured using the NRS score at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours post surgery |
| Sides effects | First 24 hours after surgery | Incidence of acute side effects attributable to opioid use (excessive sedation, respiratory depression, nausea and vomiting, pruritus, urinary retention, constipation) |
| Regional anesthesia complications | Up to first 24 hours after surgery | Incidence of complications related to subarachnoid puncture or fascial block |
| Rescue therapy request | During the first 24 hours post surgery | Time after which the first rescue therapy was requested expressed in hours |
Countries
Italy
Outcome results
None listed