NCT06042322

Brief Summary

This is a retrospective study looking at patients who received a nerve block for surgery and assessing pain after the nerve block resolves, with or without an educational intervention, over two periods of time.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Jan 2017

Longer than P75 for all trials

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jan 2017Dec 2028

Study Start

First participant enrolled

January 1, 2017

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

12 years

First QC Date

August 29, 2023

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference in maximum pain score, 0-10; (0 = no pain, 10 = worst pain)

    Difference in maximum pain score, numerical pain rating scale 0-10, 6-24 hours after nerve block between the two cohorts

    6-24 hours

Secondary Outcomes (5)

  • Average pain score 0-10; (0 = no pain, 10 = worst pain)

    6-24 hours

  • Difference in incidence of rebound pain

    6-24 hours

  • Comparison of evening opioids given

    6-24 hours

  • Difference in total opioids given

    6-24 hours

  • Difference in length of stay

    0-2 years

Study Arms (2)

TKA with nerve block no intervention

Patients who received a single shot adductor canal nerve block prior to total knee arthroplasty surgery January 2017-June 2018

TKA with nerve block with intervention

Patients who received a single shot adductor canal nerve block prior to total knee arthroplasty surgery during March 2019-March 2020, and received an educational intervention

Other: Educational intervention

Interventions

Multidisciplinary educational intervention was performed by orthopedic, anesthesia, and nursing team. This included a discussion of the patient's pain plan and a patient visit.

TKA with nerve block with intervention

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Using the Mass General Brigham Enterprise Data Warehouse, electronic health record data will be retrieved: adult patients, 18 years of age or older, who received a primary total knee arthroplasty, an adductor canal nerve block, pericapsular injection, and admitted to stay overnight (\>16 hours post nerve block).

You may qualify if:

  • primary total knee arthroplasty
  • received an adductor canal nerve block
  • received pericapsular injection by surgeon intraoperatively
  • admitted for overnight stay and \> 16 hours post-nerve block

You may not qualify if:

  • age \< 18
  • prior total knee arthroplasty on ipsilateral knee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute PainOsteoarthritis, Knee

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Yun-Yun K Chen, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 18, 2023

Study Start

January 1, 2017

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 28, 2026

Record last verified: 2026-04