Recruiting
Phase 2

Normal Saline

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT07404982

Conditions

Joint Replacement Surgery

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Normal Saline 10 mL Injection

Study Details

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.

Conditions

Joint Replacement Surgery

Study ID

NCT07404982

Start date

Mar 19, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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
7. Bromage score of 6 at the time of first PACU assessment post-enrollment

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

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

experimental: Saline administered via the intrathecal catheter

Patients randomized to the Intervention group will be administered 10ml of sterile normal saline via the intrathecal catheter post-op prior to catheter removal.

Interventions

Normal Saline 10 mL Injection

Patients randomized to this arm will have saline administration via intrathecal catheter post-op prior to removal

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. ]

Central Contacts and Locations

Central contacts

Anna Fratello

617-632-8058afratell@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Anna Fratello

6176328058afratell@bidmc.harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Jul 31, 2026

Last verified

Apr, 2026

Keywords

  • Joint Replacement
  • Knee Replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-07-31.