Comparison of Two Pain and Bleeding Control Methods in Back Surgery: A Study on Periarticular Vasoconstrictor Infiltration (PIV) vs. Erector Spinae Plane Block (ESP) in Lumbar Fusion Surgery.

Start 8 Jan 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites · Protocol IIBSP-IPV-2024-178

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruiting

Participants planned 62

Countries 1

Sites 2

lumbar arthrodesis

To compare the effectiveness of PIV block versus ESP block in reducing bleeding and improving postoperative pain control in lumbar fusion surgery, a procedure associated with significant blood loss and severe postoperative pain.

Key facts

Sponsor: Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nervous System Diseases [C10], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Trial duration: 8 Jan 2026 → ongoing
Decision date (initial): 2025-08-07
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Conditions and MedDRA coding

lumbar arthrodesis

Study design 1 period

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Randomization Patients who agree to participate in the study will be assigned to the PIV block or ESP group according to the randomization list. The anesthesiology department will have the randomization list. Blinding of the anesthesiologist administering the treatment is impossible, as these are two different blocks administered with the same drug. However, the research team conducting the follow-up will be blinded to the patient's assigned group.	Randomised Controlled	Double	[{"id":166696,"code":1,"name":"Subject"},{"id":166697,"code":2,"name":"Investigator"}]	Intervention: 2 injections (bilateral blockade) at the retrolaminar level, the thoracolumbar fascia, the supraspinous ligament, and the subcutaneous level. Volume between 150-200 ml, depending on the number of instrumentation levels. Control: 2 infiltrations (bilateral blockade) at the level of the transverse process. Volume of 20 ml/side.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

Men and women scheduled for lumbar fusion surgery (maximum of 3 instrumented levels).
Age >18 years.
Signed informed consent form

Exclusion criteria 5

Allergy to local anesthetics.
Revision lumbar spine surgery.
Patients with a local infection.
Patients with connective tissue diseases or vasculitis.
Chronic pain treated with opioids (Oral Morphine Equivalent Dose > 50 mg/day).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

The primary variable will be intraoperative bleeding in the two study groups, calculated based on the suctioned fluids from the surgical field and the gauzes after extracting the irrigation fluids. Bleeding will be measured in milliliters (ml). The research team will collect the data from the anesthesia record of the procedure.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Ropivacaína Altan 2 mg/ml solución inyectable EFG

PRD713227 · Product

Active substance: Ropivacaine Hydrochloride
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRA-ARTICULAR INJECTION
Max daily dose: 0.2 % (V/V) percent volume/volume
Max total dose: 0.2 % (V/V) percent volume/volume
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: N01BB09 — ROPIVACAINE
Marketing authorisation: 75.679
MA holder: ALTAN PHARMACEUTICALS S.A.
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 1

Adrenalina B. Braun 1 mg/ml Solución Inyectable

PRD567859 · Product

Active substance: Epinephrine
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRA-ARTICULAR INJECTION
Max daily dose: 10 µg microgram(s)
Max total dose: 10 µg microgram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: C01CA — ADRENERGIC AND DOPAMINERGIC AGENTS
Marketing authorisation: 68552
MA holder: B.BRAUN MEDICAL, S.A.
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Sponsor organisation: Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Address: Calle Sant Quinti 77-79
City: Barcelona
Postcode: 08041
Country: Spain

Scientific contact point

Organisation: Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Contact name: Alejandra Espinosa

Public contact point

Organisation: Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Contact name: Alejandra Espinosa

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Spain	Ongoing, recruiting	62	2
Rest of world	—	0	—

Investigational sites

Spain

2 sites · Ongoing, recruiting

Hospital De La Santa Creu I Sant Pau

Anesthesiology, Resuscitation and Pain Therapy, Calle De San Antonio Maria Claret 167, 08025, Barcelona

Hospital Quironsalud Murcia

Anesthesiology, Calle Miguel Hernández, 12, Murcia

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Spain	2026-01-08		2026-01-08

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol 2025-521572-56-00 pub	2
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Subject information and informed consent form (for publication)	L1_SIS and ICF pub	3
Synopsis of the protocol (for publication)	D1_Protocol synopsis 2025-521572-56-00 pub	2

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-05-15	Spain	Acceptable 2025-07-30	2025-08-07
2	NON SUBSTANTIAL MODIFICATION	NSM-2	2026-01-16	Spain	Acceptable 2025-07-30	2026-01-16