Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly
Primary Purpose
Hip Fracture, Hypotension
Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
continuous spinal anesthesia
hypobaric bupivacaine
isobaric bupivacaine
ephedrine
Sponsored by
About this trial
This is an interventional prevention trial for Hip Fracture focused on measuring hip fracture, elderly, continous spinal anesthesia, hypobaric bupivacaine, isobaric bupivacaine, hypotension
Eligibility 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.
Sites / Locations
- Institut Kassab d'Orthopédie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hypobaric
isobaric
Arm Description
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.
continuous spinal anesthesia with 2,5 mg boluses of 0.5% isboaric bupivacaine
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Total bupivacaine consumption
total dose of bupivacaine needed to perform the surgery (approximate duration of surgery : 2 hours)
The percentage of patients who experienced at least one episode of bradycardia (heart rate<50 bpm) among the 2 groups
vasopressor use
total ephedrine injected if hypotension occurred (approximate duration of surgery : 2 hours).
fluid infusion
total fluid infused intravenously at the end of surgery (approximate duration of surgery : 2 hours).
Full Information
NCT ID
NCT02428257
First Posted
April 23, 2015
Last Updated
April 27, 2015
Sponsor
Institut Kassab d'Orthopédie
1. Study Identification
Unique Protocol Identification Number
NCT02428257
Brief Title
Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly
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 Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Kassab d'Orthopédie
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Hypotension
Keywords
hip fracture, elderly, continous spinal anesthesia, hypobaric bupivacaine, isobaric bupivacaine, hypotension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hypobaric
Arm Type
Experimental
Arm Description
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.
Arm Title
isobaric
Arm Type
Active Comparator
Arm Description
continuous spinal anesthesia with 2,5 mg boluses of 0.5% isboaric bupivacaine
Intervention Type
Procedure
Intervention Name(s)
continuous spinal anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
hypobaric bupivacaine
Intervention Description
hypobaric bupivacaine was prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water.
Intervention Type
Drug
Intervention Name(s)
isobaric bupivacaine
Intervention Description
0.5% isobaric bupivacaine
Intervention Type
Drug
Intervention Name(s)
ephedrine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Total bupivacaine consumption
Description
total dose of bupivacaine needed to perform the surgery (approximate duration of surgery : 2 hours)
Time Frame
2 hours
Title
The percentage of patients who experienced at least one episode of bradycardia (heart rate<50 bpm) among the 2 groups
Time Frame
2 hours
Title
vasopressor use
Description
total ephedrine injected if hypotension occurred (approximate duration of surgery : 2 hours).
Time Frame
2 hours
Title
fluid infusion
Description
total fluid infused intravenously at the end of surgery (approximate duration of surgery : 2 hours).
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karim Raies, A. Professor
Phone
+21655208602
Email
karim.raies@gmail.com
Facility Information:
Facility Name
Institut Kassab d'Orthopédie
City
La Manouba
Country
Tunisia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olfa Kaabachi, Professor
Phone
+21698317381
Email
olfa.kaabachi@gnet.tn
12. IPD Sharing Statement
Citations:
PubMed Identifier
25058085
Citation
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.
Results Reference
background
PubMed Identifier
24972901
Citation
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.
Results Reference
background
PubMed Identifier
16632842
Citation
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.
Results Reference
result
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Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly
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