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NCT Number: NCT07404982

Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Anna Fratello

CONTACT

[email protected]

617-632-8058

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients having elective lower extremity joint replacement surgery
  • Patients >18 years

Exclusion criteria

  • 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

Treatment and study plan

Normal Saline 10 mL Injection

Drug

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Fratello

CONTACT

[email protected]

617-632-8058

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter: A Pilot Study

Acronym: IT-Cath

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 12, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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