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

NCT07245524 | Completed

• 1 other identifier: 210/2024
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Fusion; Locoregional Anaesthesia; Intrathecal Anesthesia; Erector Spina Plan Block; Multimodal General Anesthesia

Outcome Measures

Primary Outcomes (1)

• NRS score T0

  Postoperative pain upon awakening (T0), measured using the NRS (Numeric rating scale) score.

  T0: up to 20 minutes after surgery

Secondary Outcomes (6)

• NRS at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours

  2 hours, 4 hours, 6 hours, 12 hours, 24 hours post surgery

• Opioid consumption

  Consumption of morphine at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours after surgery

• Intraoperatory opioid consumption

  during the surgery

• Rescue therapy request

  During the first 24 hours post surgery

• Sides effects

  First 24 hours after surgery

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \>=18 years
• Patients with surgical indication for thoracolumbar spinal fusion with posterior access.
• ASA I, II, III

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centro Traumatologico Ortopedico (CTO) - AOU Città della Salute e della Scienza University Hospital

Torino, To, 10126, Italy

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 24, 2025
• Study Start: August 30, 2024
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

IT (1)