NCT03843970

Brief Summary

The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local anesthetic selection underlying spinal anesthesia-induced hypotension in the elderly patient. We conducted a descriptive, interventional pilot study to assess the hemodynamic impact of subarachnoid anesthesia with isobaric levobupivacaine versus isobaric bupivacaine for hip fracture surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

June 14, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

5 years

First QC Date

May 28, 2018

Last Update Submit

March 30, 2022

Conditions

Hip FracturesHemodynamic Stability

Keywords

Hip fracture, Subarachnoid block

Outcome Measures

Primary Outcomes (2)

  • Compare hemodynamic effects from invasive systolic pressure, invasive diastolic pressure and mean blood pressure.

    The measurement of invasive systolic pressure and invasive diastolic pressure and mean blood pressure mesured in mmHg.

    Intraoperative

  • Compare hemodynamic effects from heart rate.

    The measurement of heart rate in beats per minute.

    Intraoperative

Secondary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    48 hours of surgery

Study Arms (2)

Levobupivacaine Hydrochloride 0,5%

EXPERIMENTAL

The doses used of Levobupivacaine Hydrochloride 0.5% will be 6 mg and the dose of fentanyl 10 μg.

Drug: Levobupivacaine Hydrochloride 0.5%

isobaric bupivacaine 0,5%

ACTIVE COMPARATOR

The doses used of isobaric bupivacaine will be 6 mg and the dose of fentanyl 10 μg.

Drug: Isobaric bupivacaine 0.5%

Interventions

Levobupivacaine Hydrochloride 0.5%DRUG

The solution is called L solution, which contains a combination of 0.5% isobaric levobupivacaine with fentanyl. Injectable Solution.

Also known as: L solution
Levobupivacaine Hydrochloride 0,5%
Isobaric bupivacaine 0.5%DRUG

The solution is called B solution, which contains a combination of 0.5% isobaric bupivacaine with fentanyl. Injectable Solution.

Also known as: B solution
isobaric bupivacaine 0,5%

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men and Women over 65 years
  • Who meet the requirements in the pre-anesthetic to be treated with spinal anesthesia with levobupivacaine or bupivacaine, both with fentanyl,
  • Fitness: from I to IV, according to the American Society of Anesthesiologists (ASA),
  • Weight\> 40 kg,
  • Height\> 140 cm,
  • Body mass index (BMI) \<50 kg/m2,
  • Pathology cardiovascular, respiratory, renal and endocrine-metabolic,
  • Provide written informed consent

You may not qualify if:

  • Patients with uncontrolled hypertension (non-invasive systolic blood pressure\> 180 mmHg and / or non-invasive diastolic blood pressure \> 110mmHg),
  • HR\> 120 bpm,
  • SpO2 \<90% on arrival in the operating room and the contraindication to perform neuraxial anesthesia (patient refusal, infection at the site of puncture or lancing different, neuromuscular degenerative disease, hypovolemia, coagulopathy or anticoagulant therapy, morbid obesity, and extreme increase in intracranial pressure).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universitario

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Interventions

dextran - saline drug combinationElliott's solution

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • HERRERA ROSA, PhD

    General University Hospital of Valencia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HERRERA Rosa, PhD

CONTACT

+34 65920533835606rhc@gmail.com

BELDA Fco Javier, Professor

CONTACT

+34 961.973.500Fco.Javier.Belda@uv.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 28, 2018

First Posted

February 18, 2019

Study Start

June 14, 2018

Primary Completion

May 31, 2023

Study Completion

July 31, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)