NCT05315596

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
2 countries

16 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Feb 2022Dec 2030

Study Start

First participant enrolled

February 1, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

8.9 years

First QC Date

February 23, 2022

Last Update Submit

March 29, 2022

Conditions

Pain, PostoperativeAdultPain MeasurementFunctional StatusPain ManagementNeuralgiaAnalgesia

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    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).

    Day 7 after surgery and Month 1 after surgery

  • The differences in pain interference (BPI-PITS) between surgical disciplines on postoperative day 7.

    Day 7 after surgery

  • The differences in pain interference (BPI-PITS) between surgical disciplines at month 1 after surgery.

    1 Month after surgery

  • The difference in the number of patients with signs of neuropathy on postoperative day 7 between the surgical disciplines.

    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.

    1 Month after surgery

  • +4 more secondary outcomes

Other Outcomes (3)

  • Exploratory regression analysis for improving understanding of pain interference on day 7 after surgery

    First postoperative day and postoperative day 7

  • Exploratory regression analysis for improving understanding of pain intensity on postoperative day 7.

    First postoperative day and postoperative day 7

  • Exploratory regression analysis for improving understanding of pain intensity at POM1

    First postoperative day and 1 month after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients after surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Jena University Hospital

Jena, Germany

Location

Hospital General de Chihuahua Salvador Zubirán Anchondo

El Bajo, Chihuahua, Mexico

Location

Hospital Aranda de La Parra (Leon Guanajuato)

León, Guanajuato, Mexico

Location

Hospital Central Militar

Mexico City, Mexico City, Mexico

Location

Hospital San Javier Guadalajara

Guadalajara, Mexico

Location

Centro Nacional SIGLO XXI (IMSS)

Mexico City, Mexico

Location

Hospital Angeles Interlomas CDMX

Mexico City, Mexico

Location

Hospital de traumatologia y Ortopedia Lomas Verdes (IMSS)

Mexico City, Mexico

Location

Hospital fundación Medica Sur

Mexico City, Mexico

Location

Hospital General de Villacoapa (IMSS)

Mexico City, Mexico

Location

Hospital Ruben Leñero

Mexico City, Mexico

Location

Instituto Nacional de Cancerología

Mexico City, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

Mexico City, Mexico

Location

Instituto Nacional de Enfermedades Respiratorias Cosio Villegas (INER)

Mexico City, Mexico

Location

Hospital Angeles Puebla

Puebla City, Mexico

Location

Hospital Central Morones Prieto San Luis Potosi

San Luis Potosí City, Mexico

Location

Related Links

MeSH Terms

Conditions

Pain, PostoperativeAgnosiaNeuralgia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

  • Ana L Garduño López, MD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

  • Vicotor M Acosta-Nava, MD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

  • Ruth Zaslansky, DSc

    Jena University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PAIN OUT - scientific director

Study Record Dates

First Submitted

February 23, 2022

First Posted

April 7, 2022

Study Start

February 1, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 7, 2022

Record last verified: 2022-03

Locations

ME(15)DE(1)