- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06042322
Retrospective Analysis of Pain After Nerve Block in Surgical Patients
Retrospective Analysis of Pain in Patients Who Receive a Nerve Block for Surgery
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
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 no intervention
Patients who received a single shot adductor canal nerve block prior to total knee arthroplasty surgery January 2017-June 2018
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in maximum pain score, 0-10; (0 = no pain, 10 = worst pain)
Time Frame: 6-24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average pain score 0-10; (0 = no pain, 10 = worst pain)
Time Frame: 6-24 hours
|
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
|
|
Difference in incidence of rebound pain
Time Frame: 6-24 hours
|
Difference in incidence pain score ≥ 7 between 6-24 hours post nerve block between the two cohorts
|
6-24 hours
|
|
Comparison of evening opioids given
Time Frame: 6-24 hours
|
Comparison of if evening opioids were or were not given (yes/no) between the two cohorts
|
6-24 hours
|
|
Difference in total opioids given
Time Frame: 6-24 hours
|
Difference in total opioids given (mEq of morphine) between the two cohorts
|
6-24 hours
|
|
Difference in length of stay
Time Frame: 0-2 years
|
Difference in length of stay (days) between the two cohorts
|
0-2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of evening opioids given
Time Frame: 8-16 hours
|
Comparison of if evening opioids were or were not given (yes/no) between the two cohorts
|
8-16 hours
|
|
Difference in total opioids given
Time Frame: 8-16 hours
|
Difference in total opioids given (mEq of morphine) between the two cohorts
|
8-16 hours
|
|
Difference in length of stay
Time Frame: 0-30 days
|
Difference in length of stay (days) between the two cohorts
|
0-30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yun-Yun K Chen, MD, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Osteoarthritis
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Osteoarthritis, Knee
- Acute Pain
- Health Services
- Health Care Facilities Workforce and Services
- Child Health Services
- Community Health Services
- Preventive Health Services
- Early Intervention, Educational
Other Study ID Numbers
- 2023P000514
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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