Understanding the Acute Pain Phenotype in Patients Undergoing Surgery

Recruiting

• Conditions: Opioid Use; Acute Pain; Chronic Post Operative Pain
• Interventions: Procedure: regional anesthesia; Other: acute pain consultation; Procedure: no regional anesthesia; Other: no acute pain consultation

• Registration Number: NCT06466941
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-20
• Status Verified: 2024-07
• Study Start: 2024-07-03
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15
• Primary Completion: 2025-12-31
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Orthopedic surgery	no regional anesthesia	Patients who underwent orthopedic surgery
Thoracic surgery and open abdominal surgery	regional anesthesia	Patients who underwent surgery thoracic surgery or open abdominal surgery
Orthopedic surgery	regional anesthesia	Patients who underwent orthopedic surgery
Spine surgery	acute pain consultation	Patients who underwent spine surgery
Spine surgery	no acute pain consultation	Patients who underwent spine surgery
Thoracic surgery and open abdominal surgery	no regional anesthesia	Patients who underwent surgery thoracic surgery or open abdominal surgery

Primary Outcome Measures

Name	Time	Method
Maximum pain score over the first 24 hours after surgery	0-24 hours	Maximum pain score (numerical pain rating score 0-10) over the first 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Average pain score over the first 24 hours after surgery	0-24 hours	Average pain score (numerical pain rating score 0-10) over the first 24 hours after surgery
Daily pain scores	0-7days	Comparison of pain scores (numerical pain rating score 0-10) over the first 7 days after surgery
Worst pain score over the first 24 hours after surgery	0-24 hours	Worst pain score (numerical pain rating score 0-10) over the first 24 hours after surgery
Least pain score over the first 24 hours after surgery	0-24 hours	Least pain score (0-10) over the first 24 hours after surgery
Longitudinal pain scores	1-12 months	Comparison of pain scores (numerical pain rating score 0-10) at 1 month, 3 months, 6 months, and 12 months
Postoperative opioid consumption	0-7 days	Comparison of amount of opioids used after surgery (morphine milliequivalents)
Incidence of chronic postsurgical pain	3-12 months	Comparison of persistent pain in the surgical area \> 3 months after surgery

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States