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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Adult
2. On the first post-operative day and back on the ward for at least 6 hours
3. Gives consent for assessment at 3-time points
Exclusion Criteria:
1. The patient is unable to communicate
2. The patient is cognitively impaired
3. The patient is asleep
4. The patient is too ill or in too much pain and does not wish to be interviewed
5. The patient does not wish to fill in the outcomes questionnaire
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)
Facility
City
Region
Status
Jena University Hospital
Jena
Germany
Hospital General de Chihuahua Salvador Zubirán Anchondo
El Bajo
Chihuahua
Hospital Aranda de La Parra (Leon Guanajuato)
León
Guanajuato
Hospital Central Militar
Mexico City
Mexico City
Hospital San Javier Guadalajara
Guadalajara
Mexico
Centro Nacional SIGLO XXI (IMSS)
Mexico City
Mexico
Hospital Angeles Interlomas CDMX
Mexico City
Mexico
Hospital de traumatologia y Ortopedia Lomas Verdes (IMSS)
Mexico City
Mexico
Hospital fundación Medica Sur
Mexico City
Mexico
Hospital General de Villacoapa (IMSS)
Mexico City
Mexico
Hospital Ruben Leñero
Mexico City
Mexico
Instituto Nacional de Cancerología
Mexico City
Mexico
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Mexico City
Mexico
Instituto Nacional de Enfermedades Respiratorias Cosio Villegas (INER)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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