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

NCT ID: NCT05315596

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2030-12-31

Brief Summary

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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

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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

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Pain, Postoperative Adult Pain Measurement Functional Status Pain Management Neuralgia Analgesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

UNKNOWN

Sponsor Role collaborator

Centro Medico Nacional Siglo XXI IMSS

OTHER

Sponsor Role collaborator

Hospital de Traumatología y Ortopedia Lomas Verdes

UNKNOWN

Sponsor Role collaborator

Hospital Angeles Puebla

UNKNOWN

Sponsor Role collaborator

Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo

OTHER_GOV

Sponsor Role collaborator

Hospital Angeles Lomas

OTHER

Sponsor Role collaborator

Hospital San Javier Guadalajara

UNKNOWN

Sponsor Role collaborator

Hospital Aranda de La Parra (Leon Guanajuato)

UNKNOWN

Sponsor Role collaborator

Fundación Clínica Médica Sur

OTHER

Sponsor Role collaborator

Instituto Nacional de Cancerologia de Mexico

OTHER

Sponsor Role collaborator

Hospital General Dr. Ruben Leñero

OTHER

Sponsor Role collaborator

Hospital Central "Dr. Ignacio Morones Prieto"

OTHER

Sponsor Role collaborator

Hospital General Regional Número 2 Dr. Guillermo Fajardo Ortiz

UNKNOWN

Sponsor Role collaborator

Instituto Nacional de Enfermedades Respiratorias

OTHER_GOV

Sponsor Role collaborator

Hospital Central Militar

OTHER_GOV

Sponsor Role collaborator

Jena University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ruth Zaslansky

PAIN OUT - scientific director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana L Garduño López, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Vicotor M Acosta-Nava, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Ruth Zaslansky, DSc

Role: PRINCIPAL_INVESTIGATOR

Jena University Hospital

Locations

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Jena University Hospital

Jena, , Germany

Site Status

Hospital General de Chihuahua Salvador Zubirán Anchondo

El Bajo, Chihuahua, Mexico

Site Status

Hospital Aranda de La Parra (Leon Guanajuato)

León, Guanajuato, Mexico

Site Status

Hospital Central Militar

Mexico City, Mexico City, Mexico

Site Status

Hospital San Javier Guadalajara

Guadalajara, , Mexico

Site Status

Centro Nacional SIGLO XXI (IMSS)

Mexico City, , Mexico

Site Status

Hospital Angeles Interlomas CDMX

Mexico City, , Mexico

Site Status

Hospital de traumatologia y Ortopedia Lomas Verdes (IMSS)

Mexico City, , Mexico

Site Status

Hospital fundación Medica Sur

Mexico City, , Mexico

Site Status

Hospital General de Villacoapa (IMSS)

Mexico City, , Mexico

Site Status

Hospital Ruben Leñero

Mexico City, , Mexico

Site Status

Instituto Nacional de Cancerología

Mexico City, , Mexico

Site Status

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Site Status

Instituto Nacional de Enfermedades Respiratorias Cosio Villegas (INER)

Mexico City, , Mexico

Site Status

Hospital Angeles Puebla

Puebla City, , Mexico

Site Status

Hospital Central Morones Prieto San Luis Potosi

San Luis Potosí City, , Mexico

Site Status

Countries

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Germany Mexico

Related Links

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http://www.pain-out.eu

Website of PAIN OUT, a perioperative pain registry and research network

Other Identifiers

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JenaUH_pain

Identifier Type: -

Identifier Source: org_study_id

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