Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly

Hypotension Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02428257
• Other study ID #: P-2015008AR
• Status: Not yet recruiting
• Phase: N/A
• First received: April 23, 2015
• Last updated: April 27, 2015
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Institut Kassab d'Orthopédie
• Contact: Karim Raies, A. Professor
• Phone: +21655208602
• Email: karim.raies[@]gmail.com
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hip Fracture
• Hip Fractures
• Hypotension

Intervention

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.
• isobaric bupivacaine
0.5% isobaric bupivacaine
• ephedrine

Locations

Country	Name	City	State
Tunisia	Institut Kassab d'Orthopédie	La Manouba

Sponsors (1)

Lead Sponsor	Collaborator
Institut Kassab d'Orthopédie

Country where clinical trial is conducted

Tunisia, 

References & Publications (3)

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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Total bupivacaine consumption	total dose of bupivacaine needed to perform the surgery (approximate duration of surgery : 2 hours)	2 hours	No
Secondary	The percentage of patients who experienced at least one episode of bradycardia (heart rate<50 bpm) among the 2 groups		2 hours	Yes
Secondary	vasopressor use	total ephedrine injected if hypotension occurred (approximate duration of surgery : 2 hours).	2 hours	Yes
Secondary	fluid infusion	total fluid infused intravenously at the end of surgery (approximate duration of surgery : 2 hours).	2 hours	No