Understanding the Acute Pain Phenotype in Patients Undergoing Surgery

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466941
• Other study ID #: 2023P003642
• Secondary ID: 2R35GM128691-06
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: June 2024
• Source: Brigham and Women's Hospital
• Contact: Yun-Yun K Chen, MD
• Phone: 617-651-0932
• Email: ykchen[@]mgb.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

We 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. We also aim to understand how different patient phenotypes and regional anesthesia affect perioperative opioid consumption, and development of chronic postsurgical pain.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Opioid Use
• Pain, Postoperative

Intervention

Procedure:
• regional anesthesia
Patients who underwent surgery and received an epidural or peripheral nerve block
• no regional anesthesia
Patients who underwent surgery and did not received an epidural or peripheral nerve block

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. Erratum In: Ann Surg Oncol. 2021 Dec;28(Suppl 3):896. doi: 10.1245/s10434-021-10658-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum pain score over the first 24 hours after surgery	Maximum pain score (NRS 0-10) over the first 24 hours after surgery	0-24 hours
Secondary	Worst pain score over the first 24 hours after surgery	Worst pain score (NRS 0-10) over the first 24 hours after surgery	0-24 hours
Secondary	Average pain score over the first 24 hours after surgery	Average pain score (NRS 0-10) over the first 24 hours after surgery	0-24 hours
Secondary	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
Secondary	Daily pain scores	Comparison of pain scores (NRS 0-10) over the first 7 days after surgery	0-7days
Secondary	Longitudinal pain scores	Comparison of pain scores (NRS 0-10) at 1 month, 3 months, 6 months, and 12 months	1-12 months
Secondary	Postoperative opioid consumption	Comparison of amount of opioids used after surgery (morphine milliequivalents)	0-7 days
Secondary	Incidence of chronic postsurgical pain	Comparison of persistent pain in the surgical area > 3 months after surgery	3-12 months