Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT07404982
Phase
PHASE2
Status
Recruiting

Conditions

  • Joint Replacement Surgery

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 19, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control
    Patients randomized to the control group will receive a combined spinal intrathecal catheter and the same dosing of spinal medications. All aspects of care and monitoring will be the same as non-study patients. The control group will not receive a dose of intrathecal saline post-op
  • Experimental: Saline administered via the intrathecal catheter
    Patients randomized to the Intervention group will be administered 10ml of sterile normal saline via the intrathecal catheter post-op prior to catheter removal.

Primary Outcome Measure

Time to residual motor blockade reversal [ Time Frame: Initiation of spinal anesthetic to reversal, up to sixty minutes after removal of catheter. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Anna Fratello
617-632-8058

Find similar trials in Boston, MA