Reverse leftover spinal numbness after knee or hip replacement with an intrathecal saline flush
Official title: Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter: A Pilot Study
Run by Beth Israel Deaconess Medical Center · NCT07404982 · Data updated 2026-11-12
This study tests whether injecting a small amount of sterile saline through a spinal catheter can quickly reduce or eliminate leftover spinal anesthesia in adults having elective lower-extremity joint replacement.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | March 19, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | July 31, 2026 |
| Trial ID | NCT07404982 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 having elective lower-extremity joint replacement (hip or knee) who are eligible for spinal anesthesia and speak English are the intended participants.
✕Probably not a fit
People with contraindications to spinal anesthesia, unheld anticoagulation, prior intracranial bleeding, ASA status above 3, non-English speakers, or those undergoing re-operation on the same joint are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized Phase 2 interventional study that assigns adults undergoing elective lower-extremity joint replacement to receive either a 10 mL intrathecal normal saline injection via a 24-gauge catheter placed through a 20-gauge Quincke spinal needle or control. The catheter is threaded through the spinal needle into the subarachnoid space to deliver saline after surgery. Outcomes include immediate motor recovery measured in the PACU with a 1-hour post-operative survey, a 3-day follow-up survey, and medical record review. The approach is adapted from obstetric observations where saline given via a spinal catheter reduced headaches, but its use for reversing residual anesthesia in orthopedic patients is being tested.
Why it matters
Potential benefit: If successful, the method could shorten time to motor recovery and enable earlier mobilization and discharge after joint replacement.
How similar studies have gone: Saline delivered via spinal catheters has been reported to reduce post-dural puncture headache in obstetric patients, but using intrathecal saline to reverse residual motor block in orthopedic patients is novel and unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients having elective lower extremity joint replacement surgery 2. Patients \>18 years Exclusion Criteria: 1. Contraindications to spinal anesthesia (refusal, lumbar spinal hardware, spinal abnormalities) 2. Patient on anticoagulation not withheld 3. Patient receiving re-operation on the same joint 4. Prior intra-cranial bleeding 5. Patient's ASA status \>3 6. Non-English speaking 7. Bromage score of 6 at the time of first PACU assessment post-enrollment
Where it's running
-
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Anna Fratello
- Email: afratell@bidmc.harvard.edu
- Phone: 617-632-8058
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.