Clinical trial NCT05315596: Longitudinal Assessment of Pain-Related Patient-Reported Outcomes After Surgery
Official title: Longitudinal Assessment of Pain-related Patient-reported Outcomes in the Sub-acute Phase After Surgery: a Registry Study From PAIN OUT
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pain, Postoperative
Adult
Pain Measurement
Functional Status
Pain Management
Neuralgia
Analgesia
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
name: Centro Medico Nacional Siglo XXI IMSS
name: Hospital de Traumatología y Ortopedia Lomas Verdes
name: Hospital Angeles Puebla
name: Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
name: Hospital Angeles Lomas
name: Hospital San Javier Guadalajara
name: Hospital Aranda de La Parra (Leon Guanajuato)
name: Fundación Clínica Médica Sur
name: Instituto Nacional de Cancerologia de Mexico
name: Hospital General Dr. Ruben Leñero
name: Hospital Central "Dr. Ignacio Morones Prieto"
name: Hospital General Regional Número 2 Dr. Guillermo Fajardo Ortiz
name: Instituto Nacional de Enfermedades Respiratorias
name: Hospital Central Militar
First posted: 2022-04-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients after surgery

Brief 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.

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.

Eligibility criteria: 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 outcomes:
measure: The difference in pain interference scores between postoperative day 7 (POD7) and 1 month after surgery (POM1).
timeFrame: 7th day after surgery (POD7) and 1 Month (M1) after surgery
measure: The number of patients with high pain interference on the 7th day after surgery (POD7).
timeFrame: Day 7 after surgery
Secondary outcomes:
measure: Differences in pain severity (BPI-PSVS, pain severity scale) between postoperative day 7 and 1 month after surgery (POM1).
timeFrame: Day 7 after surgery and Month 1 after surgery
measure: The differences in pain interference (BPI-PITS) between surgical disciplines on postoperative day 7.
timeFrame: Day 7 after surgery
measure: The differences in pain interference (BPI-PITS) between surgical disciplines at month 1 after surgery.
timeFrame: 1 Month after surgery
measure: The difference in the number of patients with signs of neuropathy on postoperative day 7 between the surgical disciplines.
timeFrame: Day 7 after surgery
measure: The difference in the number of patients with signs of neuropathy at 1 month after surgery (POM1) between the surgical disciplines.
timeFrame: 1 Month after surgery
measure: Differences in pain interference scores between patients with vs without signs of neuropathy on postoperative day 7
timeFrame: Day 7 after surgery
measure: Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1.
timeFrame: 1 Month after surgery
measure: Differences in pain severity between patients with vs without signs of neuropathy at POM1
timeFrame: 1 Month after surgery
measure: Assess the difference in the number of patients taking analgesics o POD7 vs POD1.
timeFrame: Day 7 after surgery and 1 Month after surgery
Other outcomes:
measure: Exploratory regression analysis for improving understanding of pain interference on day 7 after surgery
timeFrame: First postoperative day and postoperative day 7
measure: Exploratory regression analysis for improving understanding of pain intensity on postoperative day 7.
timeFrame: First postoperative day and postoperative day 7
measure: Exploratory regression analysis for improving understanding of pain intensity at POM1
timeFrame: First postoperative day and 1 month after surgery
Locations:
city: Jena
country: Germany
facility: Jena University Hospital
city: Mexico City
country: Mexico
facility: Hospital Central Militar
state: Cdmx
city: El Bajo
country: Mexico
facility: Hospital General de Chihuahua Salvador Zubirán Anchondo
state: Chihuahua
city: León
country: Mexico
facility: Hospital Aranda de La Parra (Leon Guanajuato)
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Hospital San Javier Guadalajara
city: Mexico City
country: Mexico
facility: Centro Nacional SIGLO XXI (IMSS)
city: Mexico City
country: Mexico
facility: Hospital Angeles Interlomas CDMX
city: Mexico City
country: Mexico
facility: Hospital de traumatologia y Ortopedia Lomas Verdes (IMSS)
city: Mexico City
country: Mexico
facility: Hospital fundación Medica Sur
city: Mexico City
country: Mexico
facility: Hospital General de Villacoapa (IMSS)
city: Mexico City
country: Mexico
facility: Hospital Ruben Leñero
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerología
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
city: Mexico City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias Cosio Villegas (INER)
city: Puebla
country: Mexico
facility: Hospital Angeles Puebla
city: San Luis Potosi
country: Mexico
facility: Hospital Central Morones Prieto San Luis Potosi
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Ana L Garduño López, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Vicotor M Acosta-Nava, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jena University Hospital
name: Ruth Zaslansky, DSc
role: PRINCIPAL_INVESTIGATOR
References: