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UnknownNCT02428257

Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly

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.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Institut Kassab d'Orthopédie · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcontinuous spinal anesthesiaSpinal 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.
DRUGhypobaric bupivacainehypobaric bupivacaine was prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water.
DRUGisobaric bupivacaine0.5% isobaric bupivacaine
DRUGephedrine

Timeline

Start date
2015-06-01
Primary completion
2015-12-01
Completion
2015-12-01
First posted
2015-04-28
Last updated
2015-04-28

Locations

1 site across 1 country: Tunisia

Source: ClinicalTrials.gov record NCT02428257. Inclusion in this directory is not an endorsement.