Trials / Recruiting
RecruitingNCT07404982
Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter
Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter: A Pilot Study
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Beth Israel Deaconess Medical Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This is a prospective, randomized, interventional study to assess the feasibility and effectiveness of administering normal saline into the intrathecal or subarachnoid space through a small gauge epidural catheter via a single spinal needle to reverse residual anesthesia following lower extremity orthopedic surgery. This method is adapted from observations in obstetric populations where saline administered via the spinal catheter reduced headaches. This study investigates whether orthopedic patients will also receive unique benefits. Research procedures overview: * Randomization to intervention or control arm, * Use of 6-inch BD 20-gauge Quincke spinal needle, through which a B. Braun Perifix 24-gauge polyurethane catheter * Administration of normal saline * Administration of post-operative survey while in the PACU 1 hour * Follow-up survey 3 days post-surgery * Medical record review and abstraction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Normal Saline 10 mL Injection | Patients randomized to this arm will have saline administration via intrathecal catheter post-op prior to removal |
Timeline
- Start date
- 2026-02-01
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2026-02-12
- Last updated
- 2026-02-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07404982. Inclusion in this directory is not an endorsement.