PeriOPerative Spine Surgery COntrol Pain (POPSSCOP) Study: Intrathecal Morphine vs Erector Spinae Plane Block for Postoperative Pain Management in Spinal Fusion (POPSSCOP)

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

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.

Study Overview

• Status: Completed
• Conditions: Locoregional Anaesthesia; Spine Fusion; Multimodal General Anesthesia; Erector Spina Plan Block; Intrathecal Anesthesia

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Italy
  • To
    • Torino, To, Italy, 10126
      • Centro Traumatologico Ortopedico (CTO) - AOU Città della Salute e della Scienza University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: A.O.U. Città della Salute e della Scienza

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Actual): September 24, 2025
• Study Completion (Actual): September 24, 2025

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 210/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No