Understanding the Acute Pain Phenotype in Patients Undergoing Surgery

ConditionsAcute Pain Chronic Post Operative Pain Opioid Use

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorBrigham and Women's Hospital

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

regional anesthesia
Procedure/Surgery
Patients who underwent surgery and received an epidural or peripheral nerve block
no regional anesthesia
Procedure/Surgery
Patients who underwent surgery and did not received an epidural or peripheral nerve block
acute pain consultation
Other intervention
Patients who underwent surgery and had a perioperative (preop, intraop, or postop) acute pain consultation
no acute pain consultation
Other intervention
Patients who underwent surgery and did not have a perioperative (preop, intraop, or postop) acute pain consultation

Treatment groups

1,000 Participants

are divided into 3 treatment groups

Group A: Thoracic surgery and open abdominal surgery2 interventions

Group B: Orthopedic surgery2 interventions

Group C: Spine surgery2 interventions

Trial outcomes

Primary outcomes

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

Time frame

0-24 hours

Secondary outcomes

Worst pain score over the first 24 hours after surgery

Worst pain score (numerical pain rating score 0-10) over the first 24 hours after surgery

Time frame

0-24 hours

Average pain score over the first 24 hours after surgery

Average pain score (numerical pain rating score 0-10) over the first 24 hours after surgery

Time frame

0-24 hours

Least pain score over the first 24 hours after surgery

Least pain score (0-10) over the first 24 hours after surgery

Time frame

0-24 hours

Daily pain scores

Comparison of pain scores (numerical pain rating score 0-10) over the first 7 days after surgery

Time frame

0-7days

Other outcomes

Incidence of chronic postsurgical pain

Comparison of persistent pain in the surgical area \> 3 months after surgery

Time frame

3-12 months

Longitudinal pain scores

Comparison of pain scores (numerical pain rating score 0-10) at 1 month, 3 months, 6 months, and 12 months

Time frame

1-12 months

Perceived social support using the Multidimensional Scale of Perceived Social Support (MSPSS)

Comparison of social support at 7 days after surgery and 1 month postop versus baseline Scores range from 12 to 84, with higher scores indicating greater perceived support

Time frame

7 days to 1 month

pain catastrophizing using the pain catastrophizing scale (PCS)

Comparison of pain catastrophizing at 1 month, 3 months, 6 months and 12 months post op versus baseline Score range 0-52; higher scores indicate higher pain catastrophizing

Time frame

1 month-12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov

Apply now