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

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?

Study Overview

• Status: Recruiting
• Conditions: Acute Pain; Opioid Use; Chronic Post Operative Pain
• Intervention / Treatment: Procedure: regional anesthesia; Procedure: no regional anesthesia; Other: acute pain consultation; Other: no acute pain consultation

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Yun-Yun K Chen, MD; Phone Number: 617-651-0932; Email: ykchen@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Yun-Yun Chen, MD; Phone Number: (617) 798-0290‬; Email: ykchen@mgb.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Thoracic surgery and open abdominal surgery; Patients who underwent surgery thoracic surgery or open abdominal surgery	Procedure: regional anesthesia; Patients who underwent surgery and received an epidural or peripheral nerve block; Procedure: no regional anesthesia; Patients who underwent surgery and did not received an epidural or peripheral nerve block
Orthopedic surgery; Patients who underwent orthopedic surgery	Procedure: regional anesthesia; Patients who underwent surgery and received an epidural or peripheral nerve block; Procedure: no regional anesthesia; Patients who underwent surgery and did not received an epidural or peripheral nerve block
Spine surgery; Patients who underwent spine surgery	Other: acute pain consultation; Patients who underwent surgery and had a perioperative (preop, intraop, or postop) acute pain consultation; Other: no acute pain consultation; Patients who underwent surgery and did not have a perioperative (preop, intraop, or postop) acute pain consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0-24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least pain score over the first 24 hours after surgery	Least pain score (0-10) over the first 24 hours after surgery	0-24 hours
Postoperative opioid consumption	Comparison of amount of opioids used after surgery (morphine milliequivalents)	0-7 days
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	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	0-24 hours
Daily pain scores	Comparison of pain scores (numerical pain rating score 0-10) over the first 7 days after surgery	0-7days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of chronic postsurgical pain	Comparison of persistent pain in the surgical area > 3 months after surgery	3-12 months
Longitudinal pain scores	Comparison of pain scores (numerical pain rating score 0-10) at 1 month, 3 months, 6 months, and 12 months	1-12 months
Perceived social support using the Multidimensional Scale of Perceived Social Support (MSPSS)	Comparison of social support at 7 days after surgery and 1 month postop versus baseline Scores range from 12 to 84, with higher scores indicating greater perceived support	7 days to 1 month
pain catastrophizing using the pain catastrophizing scale (PCS)	Comparison of pain catastrophizing at 1 month, 3 months, 6 months and 12 months post op versus baseline Score range 0-52; higher scores indicate higher pain catastrophizing	1 month-12 months
neuropathic pain using the Douleur Neuropathique en 4 Questions (DN4)	Comparison of neuropathic pain at 1 month, 3 months, 6 months and 12 months post op versus baseline Score 0-7, higher scores indicate higher neuropathic pain	1 month-12 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Robert Edwards, PhD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• Kehlet 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.
• 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.
• Schreiber 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: regional anesthesia; pain catastrophizing; peripheral nerve blocks; psychosocial phenotype
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Acute Pain; Anesthesia and Analgesia; Anesthesia; Anesthesia, Conduction
• Other Study ID Numbers: 2023P003642; 2R35GM128691-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No