Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter

ConditionJoint Replacement Surgery

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorBeth Israel Deaconess Medical Center

About this trial

The purpose of this study is to determine the feasibility of administering a predetermined amount of normal saline into the intrathecal or subarachnoid space via a small spinal catheter to reduce or eliminate the effects of previously injected spinal anesthetic following lower extremity orthopedic surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients having elective lower extremity joint replacement surgery

Patients >18 years

Disqualifiers

Contraindications to spinal anesthesia (refusal, lumbar spinal hardware, spinal abnormalities)

Patient on anticoagulation not withheld

Patient receiving re-operation on the same joint

Prior intra-cranial bleeding

Trial design

Design model

Parallel

Treatments tested in this trial

Normal Saline 10 mL Injection
Drug
Patients randomized to this arm will have saline administration via intrathecal catheter post-op prior to removal

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: ControlNo intervention 0 interventions

Group B: Saline administered via the intrathecal catheterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Time to residual motor blockade reversal

Time to residual motor blockade reversal as measured by Bromage score following saline administration and catheter removal, up to a maximum of 60 minutes.

Time frame

Initiation of spinal anesthetic to reversal, up to sixty minutes after removal of catheter.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beth Israel Deaconess Medical Center

Lead sponsor

Source ClinicalTrials.gov

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