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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06042322
Other study ID # 2023P000514
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date July 31, 2024

Study information

Verified date January 2024
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Regional anesthesia (RA) is a vital tool that can serve as the primary anesthetic or as part of a multimodal perioperative pain regimen. RA is strongly associated with decreased acute and persistent pain and opioid consumption postoperatively. However, some patients experience an acute worsening of pain into the severe range around the time of RA resolution, also known as "rebound pain" (RP). The incidence of RP has been reported as high as 40-50% after a single shot nerve block for patients undergoing ambulatory surgery. This retrospective study aims to look at patients who received a nerve block for surgery and assessing pain after the nerve block resolves in the presence and absence of certain interventions, such as a multidisciplinary educational intervention. The investigators will assess patients who received a primary total knee arthroplasty who received a single shot adductor canal nerve block, received pericapsular injection by the surgeon, and had a length of stay > 16 hours.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 166
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - age < 18 - prior total knee arthroplasty on ipsilateral knee

Study Design


Intervention

Other:
Educational intervention
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Average pain score 0-10; (0 = no pain, 10 = worst pain) Difference in area under the curve of pain scores, numerical pain rating scale 0-10, 6-24 hours after nerve block between the two cohorts (educational intervention and non-educational intervention time periods) 6-24 hours
Secondary Difference in incidence of rebound pain Difference in incidence pain score = 7 between 6-24 hours post nerve block between the two cohorts 6-24 hours
Secondary Comparison of evening opioids given Comparison of if evening opioids were or were not given (yes/no) between the two cohorts 6-24 hours
Secondary Difference in total opioids given Difference in total opioids given (mEq of morphine) between the two cohorts 6-24 hours
Secondary Difference in length of stay Difference in length of stay (days) between the two cohorts 0-2 years
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