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Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly

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ClinicalTrials.gov Identifier: NCT02428257
Recruitment Status : Unknown
Verified April 2015 by Institut Kassab d'Orthopédie.
Recruitment status was:  Not yet recruiting
First Posted : April 28, 2015
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
Institut Kassab d'Orthopédie

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.

Condition or disease Intervention/treatment Phase
Hip Fracture Hypotension Procedure: continuous spinal anesthesia Drug: hypobaric bupivacaine Drug: isobaric bupivacaine Drug: ephedrine Not Applicable

Detailed Description:

Anesthesia for surgical repair of hip fracture is still controversial. Large retrospective studies and systematic reviews failed to demonstrate the superiority of either general or regional anesthesia. However, continuous spinal anesthesia has been shown to preserve hemodynamics better than general and single shoot spinal anesthesia. However, hypotension still occurs with continuous spinal anesthesia.

Unilateral spinal anesthesia may be achieved by hypobaric bupivacaine when patients are in the lateral position. Unilateral spinal anesthesia is more effective in preserving hemodynamics by limiting the spread of the sympathetic blockade to the operated side.

Our goal is to show that the use of hypobaric rather than isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture reduces incidence of hypotension.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hypobaric Rather Than Isobaric Bupivacaine to Prevent Anesthesia-induced Hypotension in Patients Undergoing Surgical Repair of Hip Fracture Under Continuous Spinal Anesthesia: a Prospective Randomized Controlled Study.
Study Start Date : June 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: hypobaric
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 anesthesia
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.

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

Drug: ephedrine
Active Comparator: isobaric
continuous spinal anesthesia with 2,5 mg boluses of 0.5% isboaric bupivacaine
Procedure: continuous spinal anesthesia
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.

Drug: isobaric bupivacaine
0.5% isobaric bupivacaine

Drug: ephedrine



Primary Outcome Measures :
  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 [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Total bupivacaine consumption [ Time Frame: 2 hours ]
    total dose of bupivacaine needed to perform the surgery (approximate duration of surgery : 2 hours)

  2. The percentage of patients who experienced at least one episode of bradycardia (heart rate<50 bpm) among the 2 groups [ Time Frame: 2 hours ]
  3. vasopressor use [ Time Frame: 2 hours ]
    total ephedrine injected if hypotension occurred (approximate duration of surgery : 2 hours).

  4. fluid infusion [ Time Frame: 2 hours ]
    total fluid infused intravenously at the end of surgery (approximate duration of surgery : 2 hours).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428257


Contacts
Contact: Karim Raies, A. Professor +21655208602 karim.raies@gmail.com

Locations
Tunisia
Institut Kassab d'Orthopédie Not yet recruiting
La Manouba, Tunisia
Contact: Olfa Kaabachi, Professor    +21698317381    olfa.kaabachi@gnet.tn   
Sponsors and Collaborators
Institut Kassab d'Orthopédie

Publications of Results:
Other Publications:
Responsible Party: Institut Kassab d'Orthopédie
ClinicalTrials.gov Identifier: NCT02428257     History of Changes
Other Study ID Numbers: P-2015008AR
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015

Keywords provided by Institut Kassab d'Orthopédie:
hip fracture
elderly
continous spinal anesthesia
hypobaric bupivacaine
isobaric bupivacaine
hypotension

Additional relevant MeSH terms:
Fractures, Bone
Hypotension
Hip Fractures
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Femoral Fractures
Hip Injuries
Leg Injuries
Anesthetics
Bupivacaine
Ephedrine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Vasoconstrictor Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action