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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

TypeNameDescription
DRUGNormal Saline 10 mL InjectionPatients 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

Source: ClinicalTrials.gov record NCT07404982. Inclusion in this directory is not an endorsement.