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NCT Number: NCT06466941

Understanding the Acute Pain Phenotype in Patients Undergoing Surgery

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?

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Key information

Conditions

Acute Pain Chronic Post Operative Pain Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Yun-Yun Chen, MD

CONTACT

[email protected]

(617) 798-0290‬

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regional Anesthesia

Procedure

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

no regional anesthesia

Procedure

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

acute pain consultation

Other

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

no acute pain consultation

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Worst pain score over the first 24 hours after surgery

    Time frame: 0-24 hours

    Worst pain score (numerical pain rating score 0-10) over the first 24 hours after surgery

  2. Average pain score over the first 24 hours after surgery

    Time frame: 0-24 hours

    Average pain score (numerical pain rating score 0-10) over the first 24 hours after surgery

  3. Least pain score over the first 24 hours after surgery

    Time frame: 0-24 hours

    Least pain score (0-10) over the first 24 hours after surgery

  4. Daily pain scores

    Time frame: 0-7days

    Comparison of pain scores (numerical pain rating score 0-10) over the first 7 days after surgery

  5. Postoperative opioid consumption

    Time frame: 0-7 days

    Comparison of amount of opioids used after surgery (morphine milliequivalents)

Other outcomes

  1. Incidence of chronic postsurgical pain

    Time frame: 3-12 months

    Comparison of persistent pain in the surgical area > 3 months after surgery

  2. Longitudinal pain scores

    Time frame: 1-12 months

    Comparison of pain scores (numerical pain rating score 0-10) at 1 month, 3 months, 6 months, and 12 months

  3. Perceived social support using the Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: 7 days to 1 month

    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

  4. pain catastrophizing using the pain catastrophizing scale (PCS)

    Time frame: 1 month-12 months

    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

  5. neuropathic pain using the Douleur Neuropathique en 4 Questions (DN4)

    Time frame: 1 month-12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Yun-Yun K Chen, MD

CONTACT

[email protected]

617-651-0932

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 20, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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