NCT02428257

Brief Summary

The study evaluates the potential beneficial effects on hemodynamics when hypobaric bupivacaine is used instead of isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture in elderly patients. Half of the patients will receive hypobaric bupivacaine and the over half will reveive isobaric bupivacaine and hemodynamic data will be compared.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

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

April 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

April 23, 2015

Last Update Submit

April 27, 2015

Conditions

Hip FractureHypotension

Keywords

hip fractureelderlycontinous spinal anesthesiahypobaric bupivacaineisobaric bupivacainehypotension

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients who experienced at least one episode of hypotension during surgery (fall of more than 20% of systolic blood pressure) among the 2 groups

    2 hours

Secondary Outcomes (4)

  • Total bupivacaine consumption

    2 hours

  • The percentage of patients who experienced at least one episode of bradycardia (heart rate<50 bpm) among the 2 groups

    2 hours

  • vasopressor use

    2 hours

  • fluid infusion

    2 hours

Study Arms (2)

hypobaric

EXPERIMENTAL

continuous spinal anesthesia with 2,5 mg boluses of hypobaric bupivacaine, prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water.

Procedure: continuous spinal anesthesiaDrug: hypobaric bupivacaineDrug: ephedrine

isobaric

ACTIVE COMPARATOR

continuous spinal anesthesia with 2,5 mg boluses of 0.5% isboaric bupivacaine

Procedure: continuous spinal anesthesiaDrug: isobaric bupivacaineDrug: ephedrine

Interventions

continuous spinal anesthesiaPROCEDURE

Spinal puncture performed with a 19-gauge Tuohy needle at the L4-L5 or L3-L4 interspace using a midline approach. 3 cm of a 22-gauge catheter introduced through the needle, directed to the fractured side.

hypobaricisobaric
hypobaric bupivacaineDRUG

hypobaric bupivacaine was prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water.

hypobaric
isobaric bupivacaineDRUG

0.5% isobaric bupivacaine

isobaric
ephedrineDRUG
hypobaricisobaric

Eligibility Criteria

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

You may qualify if:

  • Patients aged more than 65 years and scheduled for a surgical repair of a hip fracture.

You may not qualify if:

  • contraindication to spinal anesthesia or peripheral nerve blocks including hemostasis anomalies, local infection, allergic reaction to local anesthetics.
  • dementia.
  • consent refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Kassab d'Orthopédie

Manouba, La Manouba, Tunisia

Location

Related Publications (3)

  • Neuman MD, Rosenbaum PR, Ludwig JM, Zubizarreta JR, Silber JH. Anesthesia technique, mortality, and length of stay after hip fracture surgery. JAMA. 2014 Jun 25;311(24):2508-17. doi: 10.1001/jama.2014.6499.

    PMID: 25058085BACKGROUND

  • Patorno E, Neuman MD, Schneeweiss S, Mogun H, Bateman BT. Comparative safety of anesthetic type for hip fracture surgery in adults: retrospective cohort study. BMJ. 2014 Jun 27;348:g4022. doi: 10.1136/bmj.g4022.

    PMID: 24972901BACKGROUND

  • Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.

    PMID: 16632842RESULT

MeSH Terms

Conditions

Hip FracturesHypotension

Interventions

Ephedrine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylamines

Central Study Contacts

Karim Raies, A. Professor

CONTACT

+21655208602karim.raies@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 28, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

TU(1)