Joint Replacement SurgeryPhase 2IT-CathNCT07404982
Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter
A Phase 2 study testing Normal Saline 10 mL Injection in people with Joint Replacement Surgery, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Joint Replacement Surgery
- What is being tested?
- Normal Saline 10 mL Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients having elective lower extremity joint replacement surgery
- Patients >18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Anna Fratello, 6176328058, afratell@bidmc.harvard.edu
About this study
Official title: Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter: A Pilot Study
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.
Read the 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.
- Conditions
- Joint Replacement Surgery
- Being tested
- Normal Saline 10 mL Injection
- Keywords
- Joint Replacement, Knee Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline 10 mL InjectionDrug
Patients randomized to this arm will have saline administration via intrathecal catheter post-op prior to removal
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 |
| Saline administered via the intrathecal catheter | Experimental | Patients randomized to the Intervention group will be administered 10ml of sterile normal saline via the intrathecal catheter post-op prior to catheter removal. Receives: Drug: Normal Saline 10 mL Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to residual motor blockade reversal
Time to residual motor blockade reversal as measured by Bromage score following saline administration and catheter removal, up to a maximum of 60 minutes.
Measured: Initiation of spinal anesthetic to reversal, up to sixty minutes after removal of catheter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start19 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint Replacement SurgeryStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Spiegel, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404982
- Sponsor's protocol ID
- 2025P000372
- Acronym
- IT-Cath
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter: A Pilot Study
- ClinicalTrials.gov ID
- NCT07404982
- Acronym / sponsor ID
- IT-Cath / 2025P000372
- Conditions
- Joint Replacement Surgery
- Keywords
- Joint Replacement, Knee Replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 |
| Saline administered via the intrathecal catheter | Experimental | Drug: Normal Saline 10 mL InjectionPatients randomized to the Intervention group will be administered 10ml of sterile normal saline via the intrathecal catheter post-op prior to catheter removal. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients having elective lower extremity joint replacement surgery
- Patients >18 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline 10 mL InjectionPatients randomized to this arm will have saline administration via intrathecal catheter post-op prior to removal | Drug | Saline administered via the intrathecal catheter |
Primary outcome
Time to residual motor blockade reversal
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
Related trials for Joint Replacement Surgery
Recruiting
Positive Affirmations and Preoperative Anxiety
Total Joint Replacement Surgery, Preoperative Anxiety
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
Not yet recruitingObservational study
Impact of Nutritional Status Before Joint Replacement on Infection Risk
Periprosthetic Joint Infection (PJI), Malnutitrion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Normal Saline 10 mL Injection in people with Joint Replacement Surgery, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Fratello (617-632-8058, afratell@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to residual motor blockade reversal (time frame: Initiation of spinal anesthetic to reversal, up to sixty minutes after removal of catheter.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.