Overview
Sponsor-declared trial summary
Hip fracture
Compare the analgesic efficacy of lumbar ESP block versus no block locoregional in patients undergoing hip and proximal femur surgery through the VAS scale with pain reduction of at least 1 point after two hours postoperative.
Key facts
- Sponsor
- Asociacion Gallega De Anestesiologia Reanimacion Y Dolor
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 2 Jun 2024 → 8 May 2025
- Decision date (initial)
- 2024-05-27
- 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
Compare the analgesic efficacy of lumbar ESP block versus no block locoregional in patients undergoing hip and proximal femur surgery through the VAS scale with pain reduction of at least 1 point after two hours postoperative.
Secondary objectives 1
- - Compare the postoperative analgesic needs after performing the ESP-L block versus the control group of patients undergoing hip or proximal femur surgery. - Compare postoperative opioid consumption in the two groups. - Assess and compare the technical ease of the intervention (ESP-L block) - Compare the side effects in the two lines of treatment - Assess the level of patient satisfaction.
Conditions and MedDRA coding
Hip fracture
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Patients undergoing hip surgery. - Patients over 18 years of age. - Both genders. -ASA I-III. Classification system used by the American Society of Anesthesiologists where I is low anesthetic risk and IV is high risk . - Understanding the principles of pain assessment using a visual scale analogue EVA - Signature of consent
Exclusion criteria 1
- - Patients with contraindications for performing the technique - Technical inability to perform either of the two blocks described - Significant cognitive impairment or previous mental disability described in history clinic - Patients included in another clinical trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To compare the analgesic efficacy and safety of lumbar ESP block versus the absence of blockade in the postoperative period of hip and proximal femur surgery through the VAS scale with pain reduction of at least 1 point after two hours postoperative.
Secondary endpoints 1
- - Compare postoperative analgesic needs after performing the block ESP-L versus control group of patients undergoing hip or femur surgery proximal - Compare postoperative opioid consumption in the two groups. - Assess and compare the technical ease of the intervention (ESP-L block) - Compare the side effects in the two lines of treatment - Assess the level of patient satisfaction
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Levobupivacaina Kabi 2,5 mg/ml soluzione iniettabile/per infusione
PRD3178468 · Product
- Active substance
- Levobupivacaine
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFILTRATION, PERINEURAL USE
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB10 — LEVOBUPIVACAINE
- Marketing authorisation
- 043362146
- MA holder
- FRESENIUS KABI ITALIA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Asociacion Gallega De Anestesiologia Reanimacion Y Dolor
- Sponsor organisation
- Asociacion Gallega De Anestesiologia Reanimacion Y Dolor
- Address
- Plaza Compostela 23 2
- City
- Vigo
- Postcode
- 36201
- Country
- Spain
Scientific contact point
- Organisation
- Asociacion Gallega De Anestesiologia Reanimacion Y Dolor
- Contact name
- Laura
Public contact point
- Organisation
- Asociacion Gallega De Anestesiologia Reanimacion Y Dolor
- Contact name
- Laura
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 170 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2024-06-02 | 2025-05-08 | 2024-06-02 | 2025-05-06 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-06 | Spain | Acceptable 2024-05-27
|
2024-05-27 |