Understanding the Acute Pain Phenotype in Patients Undergoing Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: regional anesthesia, no regional anesthesia, acute pain consultation, no acute pain consultation.
- Who it may be relevant to
- Registry conditions: Acute Pain, Chronic Post Operative Pain, Opioid Use. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Patient Phenotypic Features on the Experience and Effectiveness of Regional Anesthesia and Postoperative Pain
Overview
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.
Interventions
- Procedure regional anesthesia
Patients who underwent surgery and received an epidural or peripheral nerve block - Procedure no regional anesthesia
Patients who underwent surgery and did not received an epidural or peripheral nerve block - Other acute pain consultation
Patients who underwent surgery and had a perioperative (preop, intraop, or postop) acute pain consultation - Other no acute pain consultation
Patients who underwent surgery and did not have a perioperative (preop, intraop, or postop) acute pain consultation
Primary outcome measures
- Maximum pain score over the first 24 hours after surgery [Time frame: 0-24 hours]
Secondary outcome measures (5)
- Worst pain score over the first 24 hours after surgery [Time frame: 0-24 hours]
- Average pain score over the first 24 hours after surgery [Time frame: 0-24 hours]
- Least pain score over the first 24 hours after surgery [Time frame: 0-24 hours]
- Daily pain scores [Time frame: 0-7days]
- Postoperative opioid consumption [Time frame: 0-7 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Publications
- 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
- 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. PMID 33452600
- 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
Identifiers
NCT: NCT06466941 · 2023P003642