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 — DRUGPatients 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: ControlPatients 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 catheterPatients 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
- Anna Fratello617-632-8058
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 |
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