NCT07158736

Brief Summary

Patient with atraumatic knee pain without a large knee effusion on x-ray will be randomized to receive either a genicular nerve block (GNB) or standard of care in the emergency department.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Aug 2025

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Aug 2025Sep 2026

First Submitted

Initial submission to the registry

July 17, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

August 6, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

July 17, 2025

Last Update Submit

February 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain level

    Measured by numeric rating scale: 0 (minimum value) - 10 (maximum value)

    1 hour post-enrollment

Secondary Outcomes (3)

  • Difference in Duration of Analgesia

    24 hours

  • Difference in AP-POQ-RED score

    1 hour after enrollment

  • Difference in length of stay in the emergency department

    Average 1 hour

Study Arms (2)

Genicular Nerve Block

EXPERIMENTAL

This arm of patients (17 total) will receive the genicular nerve block for their knee pain.

Procedure: Genicular nerve block with bupivacaine and corticosteroids

Standard of Care

ACTIVE COMPARATOR

This arm of patients (17 total) will receive standard of care analgesia for their knee pain

Other: Standard of Care

Interventions

This involves standard of care pain relief for patients who do not receive the genicular nerve block for knee pain, such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and opioids.

Standard of Care

genicular nerve block with ideal body-weight dosing of bupivacaine 0.5% with 4 mg dexamethasone

Genicular Nerve Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Atraumatic knee pain
  • \>17 years age
  • X-ray of the knee obtained in the ED
  • Initial pain score (numeric rating scale) 5-10

You may not qualify if:

  • Fracture or dislocation on x-ray
  • large knee joint effusion identified on x-ray
  • allergy or contraindication to local anesthetics
  • History of local anesthetic systemic toxicity after receiving local anesthetics
  • Pregnancy
  • Incarcerated
  • History of knee replacement of affected knee
  • Concern for septic joint
  • Overlying cellulitis
  • Hemodynamic instability
  • Altered mental status or inability to consent for procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Pennsylvania Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

HUP Cedar

Philadelphia, Pennsylvania, 19143, United States

RECRUITING

MeSH Terms

Interventions

BupivacaineAdrenal Cortex HormonesStandard of Care

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Michael M Shalaby, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Umar Clinical Research Coordinator, AB

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2025

First Posted

September 8, 2025

Study Start

August 6, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations