Normal Saline for Spinal Anesthesia Reversal in Joint Replacement Surgery
(IT-Cath Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to potentially speed up recovery from spinal anesthesia for individuals undergoing hip or knee replacement surgery. Researchers aim to determine if injecting a small amount of regular saline (salt water) into the spine can reduce or eliminate the effects of spinal anesthesia post-surgery. An intrathecal catheter (a small tube placed in the spine) facilitates this process. Two groups participate: one receives the saline injection, and the other does not, allowing for outcome comparison. Eligible participants are scheduled for elective hip or knee replacement surgery and do not have certain spinal issues or blood clotting concerns. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to medical advancements.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on anticoagulation (blood thinners) that cannot be withheld, you may not be eligible to participate.
What prior data suggests that this method is safe for spinal anesthesia reversal?
Research has shown that injecting normal saline (a sterile saltwater solution) into the spine is generally safe. In one study, patients received 10 mL of normal saline in the spine, which reduced headaches that can occur after spinal procedures. The study reported no serious side effects.
Another study found that spinal anesthesia with normal saline helped maintain stable blood pressure, suggesting that adding saline might not cause major issues.
This trial is in an early phase, focusing on how well patients handle this treatment. Early-phase studies often assess safety, so this trial will gather more information on how people tolerate the saline injection.
In summary, past research indicates that injecting saline into the spine is well-tolerated. However, more data from this trial will help confirm its safety.12345Why are researchers excited about this trial's treatment?
Researchers are excited about this trial because it explores a new way to reverse spinal anesthesia using normal saline during joint replacement surgeries. Unlike standard care options that typically rely on allowing the anesthesia to wear off naturally or using medications that can have side effects, this method involves administering 10ml of sterile normal saline directly into the spinal area via an intrathecal catheter. This approach is unique because it aims to safely expedite recovery from anesthesia, potentially reducing post-operative side effects and shortening hospital stays. The technique's simplicity and potential to improve patient outcomes make it an exciting area of study.
What evidence suggests that administering normal saline via an intrathecal catheter is effective for reversing spinal anesthesia in joint replacement surgery?
Research suggests that using normal saline in the spinal area might lessen the effects of spinal anesthesia after joint surgery. In this trial, participants in the intervention group will receive 10ml of sterile normal saline via the intrathecal catheter post-op. This may wash out or dilute the anesthetic, speeding up recovery. Although detailed data on this specific use is limited, the idea is that saline can remove the anesthetic from the spine more quickly, possibly smoothing the recovery process. This method remains under study, but the concept is simple: use saline to rinse away the spinal anesthetic.45678
Are You a Good Fit for This Trial?
This trial is for individuals who have undergone lower extremity joint replacement surgery and are experiencing prolonged motor block due to spinal anesthesia. Specific eligibility criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Intervention
Participants are randomized to either the control or intervention arm. The intervention group receives 10ml of sterile normal saline via the intrathecal catheter post-op.
Post-operative Monitoring
Administration of post-operative survey while in the PACU 1 hour after surgery.
Follow-up
Participants complete a follow-up survey 3 days post-surgery and medical records are reviewed.
What Are the Treatments Tested in This Trial?
Interventions
- Intrathecal Catheter
Trial Overview
The study is testing whether injecting normal saline (10 mL) into the space around the spinal cord through a catheter can reverse the lingering muscle weakness from spinal anesthesia after surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients randomized to the Intervention group will be administered 10ml of sterile normal saline via the intrathecal catheter post-op prior to catheter removal.
Patients randomized to the control group will receive a combined spinal intrathecal catheter and the same dosing of spinal medications. All aspects of care and monitoring will be the same as non-study patients. The control group will not receive a dose of intrathecal saline post-op
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Citations
The improved quality of postoperative analgesia after ... - PMC
This study showed that the addition of morphine to bupivacaine for spinal anesthesia improved the immediate quality of postoperative analgesia for up to 1 week ...
a post hoc analysis of two randomised controlled trials
Use of spinal anaesthesia compared with general anaesthesia was not associated with a reduction in postoperative sleep apnoea severity.
Comparative characteristics of the effectiveness of spinal ...
The pain severity 6 hours after surgery was the lowest in the group of bupivacaine and dexmedetomidine (group 3) — 2.05 ± 0.79 that was 67.04 ± ...
Comparing Two Regional Anesthesia Interventions for ...
The effectiveness of IPACK block as a part of multimodal analgesic approach to knee arthroplasty surgery. Enhanced recovery from superior motor sparing ...
5.
associationofanaesthetists-publications.onlinelibrary.wiley.com
associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/pdf/10.1111/anae.15569Efficacy and safety of intrathecal morphine for analgesia after ...
We systematically searched the literature for trials comparing intrathecal morphine with a control group in patients undergoing hip or knee ...
Reversal of Spinal Anesthesia Residual Motor Block Via ...
The purpose of this study is to determine the feasibility of administering a predetermined amount of normal saline into the intrathecal or ...
A comparative study-efficacy and safety of combined spinal ...
CSEA is a safe, effective, reliable technique with better hemodynamic stability along with the provision of prolonging analgesia compared to spinal anesthesia.
8.
researchgate.net
researchgate.net/publication/11878562_The_Injection_of_Intrathecal_Normal_Saline_Reduces_the_Severity_of_Postdural_Puncture_HeadacheThe Injection of Intrathecal Normal Saline Reduces ...
The immediate injection of 10 mL intrathecal normal saline after a wet tap significantly reduced the incidence of PDPH and the need for EBP.
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