Pain, PostoperativeNCT05315596
Longitudinal Assessment of Pain-Related Patient-Reported Outcomes After Surgery
An observational study of Pain, Postoperative and Adult, run by Jena University Hospital at 16 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Adult, Pain Measurement
- How many people
- 1,000 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 1 Feb 2022to 31 Dec 2030
- How long will I take part?
- 1 Month
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients after surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 2 countries
Mexico15 sites
Hospital General de Chihuahua Salvador Zubirán Anchondo
El Bajo, Chihuahua
Hospital San Javier Guadalajara
Guadalajara
Hospital Aranda de La Parra (Leon Guanajuato)
León, Guanajuato
Hospital Central Militar
Mexico City, Mexico City
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
Hospital General de Villacoapa (IMSS)
Mexico City
Hospital Ruben Leñero
Mexico City
Instituto Nacional de Cancerología
Mexico City
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Mexico City
Instituto Nacional de Enfermedades Respiratorias Cosio Villegas (INER)
Mexico City
Hospital Angeles Puebla
Puebla City
Hospital Central Morones Prieto San Luis Potosi
San Luis Potosí City
About this study
Official title: Longitudinal Assessment of Pain-related Patient-reported Outcomes in the Sub-acute Phase After Surgery: a Registry Study From PAIN OUT
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.
Read the 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.
- Conditions
- Pain, Postoperative, Adult, Pain Measurement, Functional Status, Pain Management, Neuralgia
- Medical subject headings
- Pain, Postoperative, Agnosia, Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in pain interference scores between postoperative day 7 (POD7) and 1 month after surgery (POM1).
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).
Measured: 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).
Number of patients with high pain interference at postoperative day 7 (POD7, BPI-PITS >5).
Measured: Day 7 after surgery
Secondary outcomes (9)
Differences in pain severity (BPI-PSVS, pain severity scale) between postoperative day 7 and 1 month after surgery (POM1).
We will use the pain severity variables in the BPI to assess pain on postoperative day 7 compared to Month 1 after surgery.
Measured: Day 7 after surgery and Month 1 after surgery
The differences in pain interference (BPI-PITS) between surgical disciplines on postoperative day 7.
This will be a cohort of patients undergoing surgeries from different disciplines. We anticipate that median pain interference scores will not differ between the disciplines.
Measured: Day 7 after surgery
The differences in pain interference (BPI-PITS) between surgical disciplines at month 1 after surgery.
This will be a cohort of patients undergoing surgeries from different disciplines. We anticipate that median pain interference scores will not differ between the disciplines.
Measured: 1 Month after surgery
The difference in the number of patients with signs of neuropathy on postoperative day 7 between the surgical disciplines.
The difference in the number of patients with signs of neuropathy on postoperative day 7 (DN2 score ≥ 3/7) between the surgical disciplines.
Neuropathy will be screened for using the 'Douleur Neuropathique en 2 Questions' (DN2) . Neuropathy is indicated for a score of >3/7 items in the questionnaire (Beloeil et al Early postoperative neuropathic pain assessed by the DN4 score predicts an increased risk of persistent postsurgical neuropathic pain. Eur J Anesthesiology 2017;34:652-7).
Measured: 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.
The difference in the number of patients with signs of neuropathy at POM1 (DN2 score ≥ 3/7) between the surgical disciplines.
Measured: 1 Month after surgery
Differences in pain interference scores between patients with vs without signs of neuropathy on postoperative day 7
Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) on postoperative day 7.
Measured: Day 7 after surgery
Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1.
Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1.
Measured: 1 Month after surgery
Differences in pain severity between patients with vs without signs of neuropathy at POM1
Differences in pain severity (BPI-PSVS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1.
Measured: 1 Month after surgery
Assess the difference in the number of patients taking analgesics o POD7 vs POD1.
The difference in the number of patients taking analgesics between postoperative day 7 and POM1. Patients will be asked if they are taking an analgesic at both time points.
Measured: Day 7 after surgery and 1 Month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Feb 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Centro Medico Nacional Siglo XXI IMSS, Hospital de Traumatología y Ortopedia Lomas Verdes, Hospital Angeles Puebla, Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo, Hospital Angeles Lomas, Hospital San Javier Guadalajara, Hospital Aranda de La Parra (Leon Guanajuato), Fundación Clínica Médica Sur, Instituto Nacional de Cancerologia de Mexico, Hospital General Dr. Ruben Leñero, Hospital Central "Dr. Ignacio Morones Prieto", Hospital General Regional Número 2 Dr. Guillermo Fajardo Ortiz, Instituto Nacional de Enfermedades Respiratorias, Hospital Central Militar
- Responsible party
- Principal investigator, Ruth Zaslansky, Jena University Hospital
- Investigators
- Ana L Garduño López, MD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranVicotor M Acosta-Nava, MD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranRuth Zaslansky, DSc, Principal investigator, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315596
- Sponsor's protocol ID
- JenaUH_pain
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided: Data collected by each hospital belongs to them.