Effects of Bupivacaine and Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients

Comparison of the Effects of Bupivacaine or Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients Who Underwent Hip Fracture Repair

Elderly patients with hip fracture are frail due to associated comorbidity. In these situations, regional anesthesia is recommended as it is associated to less postoperative cognitive dysfunction. However, hypotension during the process may impair ischemic cardiopathy and induce a cerebrovascular stroke. Selection of the right anesthetic agent and the administration of vasoactive drugs during the process can minimize these risks. Although bupivacaine and levobupivacaine share pharmacokinetic and pharmacodynamic properties, the studies show conflicting results. The aim of this study is to investigate if there are clinically relevant differences between these two drugs in terms of hemodynamic parameters during the surgical process with special focus on the effects on regional cerebral oximetry and cognitive status after surgery.

Study Overview

• Status: Completed
• Conditions: Complication of Anesthesia
• Intervention / Treatment: Drug: fentanyl 15 microg; Drug: Bupivacaine 7 mg; Drug: Bupivacaine 9 mg; Drug: Levobupivacaine 7 mg; Drug: Levobupivacaine 9 mg

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Hospital de Sabadell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients older than 70 years old who undergo major surgery for hip fracture and will receive intrathecal anesthesia
2. Patients in which it is considered adequate, according to the usual clinical practice, the use of bupivacaine or levobupivacaine as part of the intrathecal anesthesia
3. Patients who give their informed consent to participate in the study

Exclusion Criteria:

1. Patients allergic to anesthetic drugs to be used in the protocol or to local anesthetics amida type.
2. Patients with severe aortic stenosis or hemodynamic instability.
3. Patients who refuse the anesthetic technique or contraindication for the use of the intrathecal technique.
4. Patients with severe cognitive impairment previous to the intervention (defined by a score in the Pfeiffer test of 8-10 errors)
5. Patients in which the use of bupivacaine or levobupivacaine is contraindicated as part of the intrathecal anesthesia
6. Any condition that, in the investigator's opinion, could pose a risk to the patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine; Intrathecal administration of bupivacaine 0.5% Doses: Bupivacaine 7 mg plus fentanyl 15 ug for patients shorter than 160 cm. Bupivacaine 9 mg plus fentanyl 15 ug for patients equal or taller than 160 cm or hip replacement.	Drug: fentanyl 15 microg; Drug: Bupivacaine 7 mg; Drug: Bupivacaine 9 mg
Active Comparator: Levobupivacaine; Intrathecal administration of levobupivacaine 0.5%: Doses: Levobupivacaine 7 mg plus fentanyl 15 ug for patients shorter than 160 cm. Levobupivacaine 9 mg plus fentanyl 15 ug for patients equal or taller than 160 cm or hip replacement.	Drug: fentanyl 15 microg; Drug: Levobupivacaine 7 mg; Drug: Levobupivacaine 9 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of intraoperative time with a decrease of cerebral regional oxygen saturation (SrO2), of at least 20% with respect to baseline values	Measured continuously during surgery (an expected average of 60 minutes)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in cognitive function after 7 days with respect to preoperative function, measured by means of the Pfeiffer cognitive test	7 days post surgery

Other Outcome Measures

Outcome Measure	Time Frame
Proportion of intraoperative time with a decrease in values of cerebral regional oxygen saturation to 40% or 50%	Measured continuously during surgery (an expected average of 60 minutes)
Time to first drop of cerebral regional oxygen saturation below 40% or 50%	Assessed up to the end of surgery (an expected average of 60 minutes)
Changes in cerebral regional oxygen saturation induced by the administration of vasoconstrictor drugs	Measured continuously for the whole duration of surgery (an expected average of 60 minutes)
Doses of vasoactive drugs administered	measured up to the end of surgery (an expected average of 60 minutes)
Adverse events and mortality	30 days
Blood pressure	Measured continuously for the whole duration of surgery (an expected average of 60 minutes)
Heart Rate	Measured continuously for the whole duration of surgery (an expeted average of 60 minutes)
Oxygen saturation during the surgery	Measured continuously for the whole duration of surgery (an expected average of 60 minutes)

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli

Publications and helpful links

General Publications

• Vives R, Fernandez-Galinski D, Gordo F, Izquierdo A, Oliva JC, Colilles C, Pontes C. Effects of bupivacaine or levobupivacaine on cerebral oxygenation during spinal anesthesia in elderly patients undergoing orthopedic surgery for hip fracture: a randomized controlled trial. BMC Anesthesiol. 2019 Jan 31;19(1):17. doi: 10.1186/s12871-019-0682-1.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 23, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 10, 2013

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Bupivacaine; Levobupivacaine; Hip fracture; Intrathecal anesthesia
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine; Levobupivacaine
• Other Study ID Numbers: ANE-INTRA-2013