Acute PainNCT06466941
Understanding the Acute Pain Phenotype in Patients Undergoing Surgery
An observational study of Acute Pain and Chronic Post Operative Pain, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this observational study is to learn about how regional anesthesia (numbing medication) affects pain in patients with different psychosocial phenotypes such as different levels of concern about pain, sleep issues, and anxiety, who are having surgery. The main questions are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Chronic Post Operative Pain, Opioid Use
- What is being tested?
- regional anesthesia, no regional anesthesia and acute pain consultation
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2024to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All surgical patients are eligible for the study if they meet the inclusion/exclusion criteria. We plan to enroll patients who may or may not receive a nerve block placement (ex: epidural or peripheral nerve block) during their clinical care or have a surgery that may result in an acute postoperative pain consult (ex: spine and orthopedic surgery).
Who may be able to join
- Age ≥ 18
- English speaking
- Surgical or procedural patient who will be admitted postoperatively
- Willingness to answer psychosocial survey and/or audio recorded semi-structured interview
Who cannot join
- -Cognitive dysfunction that precludes communication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Yun-Yun Chen, MD, (617) 798-0290, ykchen@mgb.org
About this study
Official title: Impact of Patient Phenotypic Features on the Experience and Effectiveness of Regional Anesthesia and Postoperative Pain
The goal of this observational study is to learn about how regional anesthesia (numbing medication) affects pain in patients with different psychosocial phenotypes such as different levels of concern about pain, sleep issues, and anxiety, who are having surgery.
The main questions are:
- Do psychosocial factors such as concerns about pain, sleep, anxiety affect the effectiveness of regional anesthesia?
- Do psychosocial factors and regional anesthesia affect the amount of opioids used after surgery?
- Do psychosocial factors and regional anesthesia affect development of chronic postsurgical pain?
Read the detailed description
A patient's psychological profile importantly modulates pain severity, and the overall experience and impact of pain. For instance, catastrophic thinking about pain, including magnification, rumination, and helplessness, is associated with both greater pain severity and impact.
Over the years, regional anesthesia has become an integral part of multimodal pain management for many surgeries. Regional anesthesia (epidural and peripheral nerve blocks) to be associated with superior pain control, reduced time to return of bowel function, shorter intraoperative times, fewer side effects and complications, earlier ambulation and functional exercise capacity post-discharge, lower in-hospital mortality, reduced length-of-stay, improved patient satisfaction, and fewer readmissions.
The investigators aim to use of validated psychosocial surveys and semi-structured interviews to understand the phenotype of patients who will benefit the most from regional anesthesia. The investigators also aim to understand how different patient phenotypes and regional anesthesia affect perioperative opioid consumption, and development of chronic postsurgical pain.
- Conditions
- Acute Pain, Chronic Post Operative Pain, Opioid Use
- Being tested
- regional anesthesia, no regional anesthesia, acute pain consultation, no acute pain consultation
- Keywords
- regional anesthesia, peripheral nerve blocks, psychosocial phenotype, pain catastrophizing
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional anesthesiaProcedure or surgery
Patients who underwent surgery and received an epidural or peripheral nerve block
no regional anesthesiaProcedure or surgery
Patients who underwent surgery and did not received an epidural or peripheral nerve block
acute pain consultationOther
Patients who underwent surgery and had a perioperative (preop, intraop, or postop) acute pain consultation
no acute pain consultationOther
Patients who underwent surgery and did not have a perioperative (preop, intraop, or postop) acute pain consultation
| Study group | Role | What they receive |
|---|---|---|
| Thoracic surgery and open abdominal surgery | Patients who underwent surgery thoracic surgery or open abdominal surgery Receives: Procedure: regional anesthesia; Procedure: no regional anesthesia | |
| Orthopedic surgery | Patients who underwent orthopedic surgery Receives: Procedure: regional anesthesia; Procedure: no regional anesthesia | |
| Spine surgery | Patients who underwent spine surgery Receives: Other: acute pain consultation; Other: no acute pain consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain score over the first 24 hours after surgery
Maximum pain score (numerical pain rating score 0-10) over the first 24 hours after surgery
Measured: 0-24 hours
Secondary outcomes (5)
Worst pain score over the first 24 hours after surgery
Worst pain score (numerical pain rating score 0-10) over the first 24 hours after surgery
Measured: 0-24 hours
Average pain score over the first 24 hours after surgery
Average pain score (numerical pain rating score 0-10) over the first 24 hours after surgery
Measured: 0-24 hours
Least pain score over the first 24 hours after surgery
Least pain score (0-10) over the first 24 hours after surgery
Measured: 0-24 hours
Daily pain scores
Comparison of pain scores (numerical pain rating score 0-10) over the first 7 days after surgery
Measured: 0-7days
Postoperative opioid consumption
Comparison of amount of opioids used after surgery (morphine milliequivalents)
Measured: 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start3 Jul 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Edwards, Brigham and Women's Hospital
- Investigators
- Robert Edwards, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466941
- Sponsor's protocol ID
- 2023P003642
- Status last verified
- May 2026
- First submitted
- 14 Jun 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen YK, Boden KA, Schreiber KL. The role of regional anaesthesia and multimodal analgesia in the prevention of chronic postoperative pain: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1(Suppl 1):8-17. doi: 10.1111/anae.15256.
PubMed 33426669Schreiber KL, Zinboonyahgoon N, Flowers KM, Hruschak V, Fields KG, Patton ME, Schwartz E, Azizoddin D, Soens M, King T, Partridge A, Pusic A, Golshan M, Edwards RR. Prediction of Persistent Pain Severity and Impact 12 Months After Breast Surgery Using Comprehensive Preoperative Assessment of Biopsychosocial Pain Modulators. Ann Surg Oncol. 2021 Sep;28(9):5015-5038. doi: 10.1245/s10434-020-09479-2. Epub 2021 Jan 15.
PubMed 33452600Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
PubMed 16698416
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient Phenotypic Features on the Experience and Effectiveness of Regional Anesthesia and Postoperative Pain
- ClinicalTrials.gov ID
- NCT06466941
- Acronym / sponsor ID
- 2023P003642
- Conditions
- Acute Pain, Chronic Post Operative Pain, Opioid Use
- Keywords
- regional anesthesia, peripheral nerve blocks, psychosocial phenotype, pain catastrophizing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Jun 2024 (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.
The goal of this observational study is to learn about how regional anesthesia (numbing medication) affects pain in patients with different psychosocial phenotypes such as different levels of concern about pain, sleep issues, and anxiety, who are having surgery.
The main questions are:
- Do psychosocial factors such as concerns about pain, sleep, anxiety affect the effectiveness of regional anesthesia?
- Do psychosocial factors and regional anesthesia affect the amount of opioids used after surgery?
- Do psychosocial factors and regional anesthesia affect development of chronic postsurgical pain?
Detailed description
A patient's psychological profile importantly modulates pain severity, and the overall experience and impact of pain. For instance, catastrophic thinking about pain, including magnification, rumination, and helplessness, is associated with both greater pain severity and impact.
Over the years, regional anesthesia has become an integral part of multimodal pain management for many surgeries. Regional anesthesia (epidural and peripheral nerve blocks) to be associated with superior pain control, reduced time to return of bowel function, shorter intraoperative times, fewer side effects and complications, earlier ambulation and functional exercise capacity post-discharge, lower in-hospital mortality, reduced length-of-stay, improved patient satisfaction, and fewer readmissions.
The investigators aim to use of validated psychosocial surveys and semi-structured interviews to understand the phenotype of patients who will benefit the most from regional anesthesia. The investigators also aim to understand how different patient phenotypes and regional anesthesia affect perioperative opioid consumption, and development of chronic postsurgical pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thoracic surgery and open abdominal surgery | – | Procedure: regional anesthesia, Procedure: no regional anesthesiaPatients who underwent surgery thoracic surgery or open abdominal surgery |
| Orthopedic surgery | – | Procedure: regional anesthesia, Procedure: no regional anesthesiaPatients who underwent orthopedic surgery |
| Spine surgery | – | Other: acute pain consultation, Other: no acute pain consultationPatients who underwent spine surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All surgical patients are eligible for the study if they meet the inclusion/exclusion criteria. We plan to enroll patients who may or may not receive a nerve block placement (ex: epidural or peripheral nerve block) during their clinical care or have a surgery that may result in an acute postoperative pain consult (ex: spine and orthopedic surgery).
Key inclusion criteria (4 listed)
- Age ≥ 18
- English speaking
- Surgical or procedural patient who will be admitted postoperatively
- Willingness to answer psychosocial survey and/or audio recorded semi-structured interview
Key exclusion criteria (1 listed)
- -Cognitive dysfunction that precludes communication
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 |
|---|---|---|
| regional anesthesiaPatients who underwent surgery and received an epidural or peripheral nerve block | Procedure or surgery | Orthopedic surgery, Thoracic surgery and open abdominal surgery |
| no regional anesthesiaPatients who underwent surgery and did not received an epidural or peripheral nerve block | Procedure or surgery | Orthopedic surgery, Thoracic surgery and open abdominal surgery |
| acute pain consultationPatients who underwent surgery and had a perioperative (preop, intraop, or postop) acute pain consultation | Other | Spine surgery |
| no acute pain consultationPatients who underwent surgery and did not have a perioperative (preop, intraop, or postop) acute pain consultation | Other | Spine surgery |
Primary outcome
Maximum pain score over the first 24 hours after surgery
Time frame: 0-24 hours
Maximum pain score (numerical pain rating score 0-10) over the first 24 hours after surgery
5 secondary outcomes
Worst pain score over the first 24 hours after surgery
Time frame: 0-24 hours
Average pain score over the first 24 hours after surgery
Time frame: 0-24 hours
Least pain score over the first 24 hours after surgery
Time frame: 0-24 hours
Daily pain scores
Time frame: 0-7days
Postoperative opioid consumption
Time frame: 0-7 days
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 22 May 2026.
- Background: PubMed 33426669Chen YK, Boden KA, Schreiber KL. The role of regional anaesthesia and multimodal analgesia in the prevention of chronic postoperative pain: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1(Suppl 1):8-17. doi: 10.1111/anae.15256.
- Background: PubMed 33452600Schreiber KL, Zinboonyahgoon N, Flowers KM, Hruschak V, Fields KG, Patton ME, Schwartz E, Azizoddin D, Soens M, King T, Partridge A, Pusic A, Golshan M, Edwards RR. Prediction of Persistent Pain Severity and Impact 12 Months After Breast Surgery Using Comprehensive Preoperative Assessment of Biopsychosocial Pain Modulators. Ann Surg Oncol. 2021 Sep;28(9):5015-5038. doi: 10.1245/s10434-020-09479-2. Epub 2021 Jan 15.
- Background: PubMed 16698416Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
- Individual participant dataSharing planned: No
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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.
Robert Edwards, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain and Chronic Post Operative Pain, run by Brigham and Women's Hospital at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Yun-Yun K Chen, MD (617-651-0932, ykchen@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum pain score over the first 24 hours after surgery (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06466941, which also lists 3 linked publications.
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 22 May 2026.