Understanding the Acute Pain Phenotype in Patients Undergoing Surgery

NCT06466941 | Recruiting

• 2 other identifiers: 2023P0036422R35GM128691-06
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Pain; Chronic Post Operative Pain; Opioid Use

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Worst pain score over the first 24 hours after surgery

  0-24 hours

• Average pain score over the first 24 hours after surgery

  0-24 hours

• Least pain score over the first 24 hours after surgery

  0-24 hours

• Daily pain scores

  0-7days

• Longitudinal pain scores

  1-12 months

Study Arms (3)

Thoracic surgery and open abdominal surgery

Patients who underwent surgery thoracic surgery or open abdominal surgery

Procedure: regional anesthesia; Procedure: no regional anesthesia

Orthopedic surgery

Patients who underwent orthopedic surgery

Procedure: regional anesthesia; Procedure: no regional anesthesia

Spine surgery

Patients who underwent spine surgery

Other: acute pain consultation; Other: no acute pain consultation

Interventions

regional anesthesia PROCEDURE

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

Orthopedic surgery; Thoracic surgery and open abdominal surgery

no regional anesthesia PROCEDURE

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

Orthopedic surgery; Thoracic surgery and open abdominal surgery

acute pain consultation OTHER

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

Spine surgery

no acute pain consultation OTHER

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

Spine surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Cognitive dysfunction that precludes communication

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 33426669 BACKGROUND

• 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.

  PMID: 33452600 BACKGROUND

• 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.

  PMID: 16698416 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Kristin L Schreiber, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-Yun K Chen, MD

CONTACT

617-651-0932; ykchen@mgb.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 20, 2024
• Study Start: July 3, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)