Centro Traumatologico Ortopedico (CTO) - AOU Città della Salute e della Scienza University Hospital
Torino, To, 10126, Italy
NCT Number: NCT07245524
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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Notify Me18 year and older
All sexes
Observational
Torino, To, 10126, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: T0: up to 20 minutes after surgery
Postoperative pain upon awakening (T0), measured using the NRS (Numeric rating scale) score.
Time frame: 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
Time frame: 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.
Time frame: during the surgery
Opioid consumption during surgery: intraoperatory remifentanil dosage
Time frame: During the first 24 hours post surgery
Time after which the first rescue therapy was requested expressed in hours
Time frame: 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)
Time frame: Up to first 24 hours after surgery
Incidence of complications related to subarachnoid puncture or fascial block
A.O.U. Città della Salute e della Scienza
Other
PeriOPerative Spine Surgery COntrol Pain (POPSSCOP) Study: Intrathecal Morphine vs Erector Spinae Plane Block for Postoperative Pain Management in Spinal Fusion. Single-center Prospective Observational Study
Acronym: POPSSCOP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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