Joint Replacement Surgery
Conditions
Keywords
Joint Replacement, Knee Replacement
Brief 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.
Interventions
Patients randomized to this arm will have saline administration via intrathecal catheter post-op prior to removal
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to residual motor blockade reversal | Initiation of spinal anesthetic to reversal, up to sixty minutes after removal of catheter. | Time to residual motor blockade reversal as measured by Bromage score following saline administration and catheter removal, up to a maximum of 60 minutes. |
Countries
United States
Contacts
CONTACTAnna Fratello
Outcome results
None listed