Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia

NCT02544269 | Terminated Phase 4 DMC

• 2 other identifiers: HIP/FUSION#12015-003498-13
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the hemodynamic effect of lumbosacral plexus blockades versus spinal anesthesia for hip replacement. Half of participants will receive lumbosacral plexus blockade and the other half will receive continuous spinal anesthesia.

Conditions

Total Hip Replacement

Keywords

Lumbosacral plexus blockade; Continuous spinal anesthesia; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• Change of cardiac output

  Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.

  Up to 1 hour

Secondary Outcomes (14)

• Time for performance of nerve blocks

  At time of nerve block performance

• Success rate of nerve blocks

  1 day

• Change of cardiac stroke volume

  Up to 1 hour

• Change of systemic vascular resistance

  Up to 1 hour

• Change of mean arterial pressure

  Up to 1 hour

Study Arms (2)

Lumbosacral plexus blockade

EXPERIMENTAL

Peripheral nerve blockade of lumbar and sacral plexus with ropivacaine max 225 mg perineural

Procedure: Ropivacaine

Continuous spinal anesthesia

ACTIVE COMPARATOR

Continuous spinal anesthesia with plain bupivacaine max 15 mg intrathecal

Procedure: Bupivacaine

Interventions

Ropivacaine PROCEDURE

Lumbosacral plexus blockade with ropivacaine.

Lumbosacral plexus blockade

Bupivacaine PROCEDURE

Regional anesthesia with bupivacaine titrated to the lowest effective dose

Continuous spinal anesthesia

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients for total hip replacement at Aarhus University Hospital
• Age \>= 50 years
• American Society of Anesthesiologists physical status classification score I-III
• Informed consent

You may not qualify if:

• Lack of ability to cooperate
• Lack of ability to speak Danish
• Chronic pain, that demands opioid treatment. Not inkl. hip pain.
• Previous venous thromboembolic event
• Previous major back surgery
• Severe cardiopulmonary disease (NYHA class 4)
• Severe untreated hypertension (systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 110 mm Hg)
• Obesity (BMI \> 35 kg/m\^2)
• Pregnancy
• Allergy towards the used local analgetics
• Current treatment with amiodarone or verapamil

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Regionshospitalet Silkeborg: collaborator

Study Sites (1)

Center for Planlagt Kirurgi

Silkeborg, 8600, Denmark

Location

MeSH Terms

Interventions

Ropivacaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Niels D Nielsen, MD

  Aarhus University, Dept. of Clinical Medicine

  PRINCIPAL INVESTIGATOR

• Thomas F Bendtsen, MD, PhD

  Aarhus University Hospital, Dept. of Anesthesiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 9, 2015
• Study Start: June 1, 2016
• Primary Completion: January 25, 2017
• Study Completion: January 25, 2017
• Last Updated: May 5, 2017

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)