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Enrolling by invitation NCT05315596

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

— Observational Pain, Postoperative Adult Pain Measurement Functional Status

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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pain, Postoperative, Adult, Pain Measurement, Functional Status. 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
Germany, Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Longitudinal Assessment of Pain-related Patient-reported Outcomes in the Sub-acute Phase After Surgery: a Registry Study From PAIN OUT

Overview

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.

Detailed description

A high proportion of patients experience moderate to severe pain after surgery. However, most of the knowledge about this comes from studies where patients are evaluated in the hours and up until the first postoperative day. Alternatively, patients are assessed several months (eg 3 or later) after surgery, to evaluate the development of chronic pain related to surgery (CPSP) and most patients do not develop CPSP.

This study aims to learn how patients recover concerning pain and function once they return home after surgery. How long is it before they can resume their daily activities and to do so in comfort? Do they take treatment for pain? Do they have pain restricted to the surgical incision or it is more widespread? There is little knowledge as to whether there are signs of nerve injury in the days close to surgery. This type of pain might lead to chronic pain in later stages.

Patients will be assessed at three time points: the first day after surgery, the 7th day after surgery, and 1 month.

The information we obtain will offer healthcare providers, from multiple hospitals, information about the care they provide to their patients for pain while patients are still in hospital and insights as to how the care might be improved, once they are discharged.

Primary outcome measures

  • The difference in pain interference scores between postoperative day 7 (POD7) and 1 month after surgery (POM1). [Time frame: 7th day after surgery (POD7) and 1 Month (M1) after surgery]
  • The number of patients with high pain interference on the 7th day after surgery (POD7). [Time frame: Day 7 after surgery]
Secondary outcome measures (9)
  • Differences in pain severity (BPI-PSVS, pain severity scale) between postoperative day 7 and 1 month after surgery (POM1). [Time frame: Day 7 after surgery and Month 1 after surgery]
  • The differences in pain interference (BPI-PITS) between surgical disciplines on postoperative day 7. [Time frame: Day 7 after surgery]
  • The differences in pain interference (BPI-PITS) between surgical disciplines at month 1 after surgery. [Time frame: 1 Month after surgery]
  • The difference in the number of patients with signs of neuropathy on postoperative day 7 between the surgical disciplines. [Time frame: Day 7 after surgery]
  • The difference in the number of patients with signs of neuropathy at 1 month after surgery (POM1) between the surgical disciplines. [Time frame: 1 Month after surgery]
  • Differences in pain interference scores between patients with vs without signs of neuropathy on postoperative day 7 [Time frame: Day 7 after surgery]
  • Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1. [Time frame: 1 Month after surgery]
  • Differences in pain severity between patients with vs without signs of neuropathy at POM1 [Time frame: 1 Month after surgery]
  • Assess the difference in the number of patients taking analgesics o POD7 vs POD1. [Time frame: Day 7 after surgery and 1 Month after surgery]

Eligibility criteria

Inclusion criteria

  • Adult
  • On the first post-operative day and back on the ward for at least 6 hours
  • Gives consent for assessment at 3-time points

Exclusion criteria

  • The patient is unable to communicate
  • The patient is cognitively impaired
  • The patient is asleep
  • The patient is too ill or in too much pain and does not wish to be interviewed
  • The patient does not wish to fill in the outcomes questionnaire

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

Mexico · 15 centers
  • Hospital General de Chihuahua Salvador Zubirán Anchondo — El Bajo
  • Hospital Aranda de La Parra (Leon Guanajuato) — León
  • Hospital Central Militar — Mexico City
  • Hospital San Javier Guadalajara — Guadalajara
  • Centro Nacional SIGLO XXI (IMSS) — Mexico City
  • Hospital Angeles Interlomas CDMX — Mexico City
  • Hospital de traumatologia y Ortopedia Lomas Verdes (IMSS) — Mexico City
  • Hospital fundación Medica Sur — Mexico City
  • … and 7 more centers
Germany · 1 center
  • Jena University Hospital — Jena

Identifiers

NCT: NCT05315596 · JenaUH_pain

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗