Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Normal Saline 10 mL Injection.
- Who it may be relevant to
- Registry conditions: Joint Replacement Surgery. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter: A Pilot Study
Overview
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 * Medical record review and abstraction.
Interventions
- Drug Normal Saline 10 mL Injection
Patients randomized to this arm will have saline administration via intrathecal catheter post-op prior to removal
Primary outcome measures
- Time to residual motor blockade reversal [Time frame: Initiation of spinal anesthetic to reversal, up to sixty minutes after removal of catheter.]
Eligibility criteria
Inclusion criteria
- Patients having elective lower extremity joint replacement surgery
- Patients >18 years
Exclusion criteria
- Contraindications to spinal anesthesia (refusal, lumbar spinal hardware, spinal abnormalities)
- Patient on anticoagulation not withheld
- Patient receiving re-operation on the same joint
- Prior intra-cranial bleeding
- Patient's ASA status >3
- Non-English speaking
- Bromage score of 6 at the time of first PACU assessment post-enrollment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Beth Israel Deaconess Medical Center — Boston
Identifiers
NCT: NCT07404982 · 2025P000372