Understanding the Acute Pain Phenotype in Patients Undergoing Surgery

NCT ID: NCT06466941

Last Updated: 2024-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-03

Study Completion Date

2027-07-01

Brief Summary

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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

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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

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Acute Pain Chronic Post Operative Pain Opioid Use

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Thoracic surgery and open abdominal surgery

Patients who underwent surgery thoracic surgery or open abdominal surgery

regional anesthesia

Intervention Type PROCEDURE

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

no regional anesthesia

Intervention Type PROCEDURE

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

Orthopedic surgery

Patients who underwent orthopedic surgery

regional anesthesia

Intervention Type PROCEDURE

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

no regional anesthesia

Intervention Type PROCEDURE

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

Spine surgery

Patients who underwent spine surgery

acute pain consultation

Intervention Type OTHER

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

no acute pain consultation

Intervention Type OTHER

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

Interventions

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regional anesthesia

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

Intervention Type PROCEDURE

no regional anesthesia

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

Intervention Type PROCEDURE

acute pain consultation

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

Intervention Type OTHER

no acute pain consultation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristin Schreiber

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin L Schreiber, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yun-Yun K Chen, MD

Role: CONTACT

617-651-0932

Facility Contacts

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Kristin L Schreiber, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 33426669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33452600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16698416 (View on PubMed)

Other Identifiers

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2R35GM128691-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023P003642

Identifier Type: -

Identifier Source: org_study_id

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