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Completed

NCT Number: NCT07245524

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Torino, To, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. NRS score T0

    Time frame: T0: up to 20 minutes after surgery

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

Secondary outcomes

  1. NRS at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours

    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

  2. Opioid consumption

    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.

  3. Intraoperatory opioid consumption

    Time frame: during the surgery

    Opioid consumption during surgery: intraoperatory remifentanil dosage

  4. Rescue therapy request

    Time frame: During the first 24 hours post surgery

    Time after which the first rescue therapy was requested expressed in hours

  5. Sides effects

    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)

  6. Regional anesthesia complications

    Time frame: Up to first 24 hours after surgery

    Incidence of complications related to subarachnoid puncture or fascial block

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

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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