Hemodynamic safety of isobaric levobupivacaine versus isobaric bupivacaine for subarachnoid anesthesia in patients over 65 years old undergoing hip fracture surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

14 Jun 2018 → ongoing

Decision date (initial)

2025-02-04

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Hospital Clínico Universitario de Valencia. Anesthesia Department

External identifiers

EU CT number

2025-520970-21-00

EudraCT number

2017-003113-26

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Pharmacodynamic

The primary objective of the study will be to compare the hemodynamic effects of isobaric levobupivacaine and isobaric bupivacaine, both in combination with fentanyl, in patients aged 65 years or older undergoing hip fracture surgery. This comparison will be based on invasive systolic arterial pressure (PASI), invasive diastolic arterial pressure (PADI), invasive mean arterial pressure (PAMI), arterial oxygen saturation (SatO2) measured in %, and heart rate (HR) measured in beats per minute (bpm).

Secondary objectives 1

1. To compare the possible adverse events during surgery and 48 hours post-surgery between both groups.

Conditions and MedDRA coding

Hip fracture

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients aged 65 years or older
2. Underwent hip fracture surgery
3. Eligible for intradural anesthesia with levobupivacaine and fentanyl or bupivacaine and fentanyl, as determined in the pre-anesthetic visit.
4. Physical status classified between I and IV according to the American Society of Anesthesiologists (ASA).
5. Weight > 40 kg and Height > 140 cm. Body mass index (BMI) < 50 kg/m²
6. Presence of cardiovascular, respiratory, renal, or endocrine-metabolic condition
7. Provided informed consent to participate in the study.

Exclusion criteria 4

1. Uncontrolled arterial hypertension (non-invasive systolic blood pressure >180 mmHg and/or non-invasive diastolic blood pressure >110 mmHg).
2. Heart rate (HR) >120 bpm
3. Oxygen saturation (SpO2) <90% upon arrival at the operating room
4. Contraindications to neuraxial anesthesia, including: Patient refusal, Infection at or near the puncture site, Degenerative neuromuscular disease, Hypovolemia, Coagulopathy or anticoagulant treatment, Extreme morbid obesity or Increased intracranial pressure.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Invasive systolic arterial pressure (PASI), invasive diastolic arterial pressure (PADI), invasive mean arterial pressure (PAMI), arterial oxygen saturation (SatO2) measured in %, heart rate (HR) measured in beats per minute (bpm), and partial oxygen saturation (SpO2%) measured in %.

Secondary endpoints 2

1. Cardiac index (CI), peripheral vascular resistance (PVR), partial arterial oxygen pressure (PaO2), and partial arterial carbon dioxide pressure (PaCO2) measured in mmHg, pH, arterial lactate (Lc) measured in mmol/L, and arterial hemoglobin (Hb) measured in g/dL.
2. Adverse events during surgery and up to 48 hours after the surgical procedure will include: cardiovascular and respiratory adverse events, associated with the surgical technique and with the anesthetic technique.

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Sponsor organisation

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Address

Avenida Menendez Y Pelayo 4

City

Valencia

Postcode

46010

Country

Spain

Scientific contact point

Organisation

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Contact name

Rosa Mª Herrera Castro

Public contact point

Organisation

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Contact name

Rosa Mª Herrera Castro

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 5 files

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

Application history

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