Spine FusionPOPSSCOPNCT07245524
PeriOPerative Spine Surgery COntrol Pain (POPSSCOP) Study: Intrathecal Morphine vs Erector Spinae Plane Block for Postoperative Pain Management in Spinal Fusion
An observational study of Spine Fusion and Locoregional Anaesthesia, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Fusion, Locoregional Anaesthesia, Intrathecal Anesthesia
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 30 Aug 2024to 24 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age >=18 years
- Patients with surgical indication for thoracolumbar spinal fusion with posterior access.
- ASA I, II, III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Centro Traumatologico Ortopedico (CTO) - AOU Città della Salute e della Scienza University Hospital
Torino, To, 10126
About this study
Official 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
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:
Read more
● 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
NRS score T0
Postoperative pain upon awakening (T0), measured using the NRS (Numeric rating scale) score.
Measured: T0: up to 20 minutes after surgery
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: during the surgery
Rescue therapy request
Time after which the first rescue therapy was requested expressed in hours
Measured: 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)
Measured: First 24 hours after surgery
Regional anesthesia complications
Incidence of complications related to subarachnoid puncture or fascial block
Measured: Up to first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start30 Aug 2024
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245524
- Sponsor's protocol ID
- 210/2024
- Acronym
- POPSSCOP
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07245524
- Acronym / sponsor ID
- POPSSCOP / 210/2024
- Conditions
- Spine Fusion, Locoregional Anaesthesia, Intrathecal Anesthesia, Erector Spina Plan Block, Multimodal General Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age >=18 years
- Patients with surgical indication for thoracolumbar spinal fusion with posterior access.
- ASA I, II, III
Key exclusion criteria (6 listed)
- Patient refusal
- Emergency surgery
- Chronic use (>12 weeks) of opioids in the preoperative period
- Drug addiction
- Contraindication to drugs contained in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
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
Opioid consumption
Time frame: Consumption of morphine at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours after surgery
Intraoperatory opioid consumption
Time frame: during the surgery
Rescue therapy request
Time frame: During the first 24 hours post surgery
Sides effects
Time frame: First 24 hours after surgery
Regional anesthesia complications
Time frame: Up to first 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Fusion and Locoregional Anaesthesia, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS score T0 (time frame: T0: up to 20 minutes after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.