Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Location status: Recruiting
NCT Number: NCT07404982
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.
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Interventional
Phase 2
Boston, Massachusetts, 02215, United States
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients randomized to this arm will have saline administration via intrathecal catheter post-op prior to removal
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Beth Israel Deaconess Medical Center
Other
Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter: A Pilot Study
Acronym: IT-Cath
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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