Longitudinal Assessment of Pain-Related Patient-Reported Outcomes After Surgery

Condition(s) studied

Study summary

Little is known about pain-related outcomes experienced by patients in the first few weeks after surgery, once they are discharged from hospital.

This study aims to characterize pain, pain-related interference, and early neuropathic pain in the sub-acute phase after surgery.

Eligibility

Primary outcome measure(s)

• The difference in pain interference scores between postoperative day 7 (POD7) and 1 month after surgery (POM1). — 7th day after surgery (POD7) and 1 Month (M1) after surgery
  We will assess whether pain-related functional impairment on postoperative day 7 is associated with functional pain-related impairment 1 month after surgery. Functional pain impairment will be assessed using the BPI short-form questionnaire and calculated as a Pain Interference Total Score (PITS) from the 7 interference questions in the BPI. Patients will be allocated to groups of no (PITS=0)/mild-(PITS=1-2)/ moderate /(PITS=2-5) and severe interference (PITS\>5). Mean scores of the 2 domains within the functional items, physical interference (general activity, walking ability, and work) and effective interference (mood, enjoyment of life, and relations with other persons) will also be calculated. Sleep will addressed separately as it does not improve psychometric properties of the BPI interference scale. This methodology has been used in another PAIN OUT study, evaluating function at 6 months after surgery (Stamer et al, Pain. 2019 Aug;160(8):1856-1865).
• The number of patients with high pain interference on the 7th day after surgery (POD7). — Day 7 after surgery
  Number of patients with high pain interference at postoperative day 7 (POD7, BPI-PITS \>5).

Trial sites (16)