Regional Anesthesia MorbidityNCT06042322
Retrospective Analysis of Pain After Nerve Block in Surgical Patients
An observational study of Regional Anesthesia Morbidity and Acute Pain, run by Brigham and Women's Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Regional Anesthesia Morbidity, Acute Pain, Knee Osteoarthritis
- What is being tested?
- Educational intervention
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- age < 18
- prior total knee arthroplasty on ipsilateral knee
About this study
Official title: Retrospective Analysis of Pain in Patients Who Receive a Nerve Block for Surgery
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.
Read the 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.
- Being tested
- Educational intervention
- Medical subject headings
- Acute Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-24 hours
Secondary outcomes (5)
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)
Measured: 6-24 hours
Difference in incidence of rebound pain
Difference in incidence pain score ≥ 7 between 6-24 hours post nerve block between the two cohorts
Measured: 6-24 hours
Comparison of evening opioids given
Comparison of if evening opioids were or were not given (yes/no) between the two cohorts
Measured: 6-24 hours
Difference in total opioids given
Difference in total opioids given (mEq of morphine) between the two cohorts
Measured: 6-24 hours
Difference in length of stay
Difference in length of stay (days) between the two cohorts
Measured: 0-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Jan 2017
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-Yun K. Chen, Brigham and Women's Hospital
- Investigators
- Yun-Yun K Chen, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042322
- Sponsor's protocol ID
- 2023P000514
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Pain in Patients Who Receive a Nerve Block for Surgery
- ClinicalTrials.gov ID
- NCT06042322
- Acronym / sponsor ID
- 2023P000514
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Educational interventionPatients 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 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- age < 18
- prior total knee arthroplasty on ipsilateral knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational interventionMultidisciplinary educational intervention was performed by orthopedic, anesthesia, and nursing team. This included a discussion of the patient's pain plan and a patient visit. | Other | TKA with nerve block with intervention |
Primary outcome
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
5 secondary outcomes
Average pain score 0-10; (0 = no pain, 10 = worst pain)
Time frame: 6-24 hours
Difference in incidence of rebound pain
Time frame: 6-24 hours
Comparison of evening opioids given
Time frame: 6-24 hours
Difference in total opioids given
Time frame: 6-24 hours
Difference in length of stay
Time frame: 0-2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Yun K Chen, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia Morbidity and Acute Pain, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in maximum pain score, 0-10; (0 = no pain, 10 = worst pain) (time frame: 6-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.