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Understanding the Acute Pain Phenotype in Patients Undergoing Surgery

Impact of Patient Phenotypic Features on the Experience and Effectiveness of Regional Anesthesia and Postoperative Pain

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06466941
Enrollment
1000
Registered
2024-06-20
Start date
2024-07-03
Completion date
2028-12-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Chronic Post Operative Pain, Opioid Use

Keywords

regional anesthesia, peripheral nerve blocks, psychosocial phenotype, pain catastrophizing

Brief 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. Do psychosocial factors such as concerns about pain, sleep, anxiety affect the effectiveness of regional anesthesia? 2. Do psychosocial factors and regional anesthesia affect the amount of opioids used after surgery? 3. 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.

Interventions

PROCEDUREregional anesthesia

Patients who underwent surgery and received an epidural or peripheral nerve block

PROCEDUREno regional anesthesia

Patients who underwent surgery and did not received an epidural or peripheral nerve block

OTHERacute pain consultation

Patients who underwent surgery and had a perioperative (preop, intraop, or postop) acute pain consultation

OTHERno acute pain consultation

Patients who underwent surgery and did not have a perioperative (preop, intraop, or postop) acute pain consultation

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

-Cognitive dysfunction that precludes communication

Design outcomes

Primary

MeasureTime frameDescription
Maximum pain score over the first 24 hours after surgery0-24 hoursMaximum pain score (numerical pain rating score 0-10) over the first 24 hours after surgery

Secondary

MeasureTime frameDescription
Worst pain score over the first 24 hours after surgery0-24 hoursWorst pain score (numerical pain rating score 0-10) over the first 24 hours after surgery
Average pain score over the first 24 hours after surgery0-24 hoursAverage pain score (numerical pain rating score 0-10) over the first 24 hours after surgery
Least pain score over the first 24 hours after surgery0-24 hoursLeast pain score (0-10) over the first 24 hours after surgery
Daily pain scores0-7daysComparison of pain scores (numerical pain rating score 0-10) over the first 7 days after surgery
Postoperative opioid consumption0-7 daysComparison of amount of opioids used after surgery (morphine milliequivalents)

Countries

United States

Contacts

CONTACTYun-Yun K Chen, MD
ykchen@mgb.org617-651-0932
PRINCIPAL_INVESTIGATORRobert Edwards, PhD

Brigham and Women's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026