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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain, Postoperative; Analgesia; Neuralgia; Pain Management; Functional Status; Adult; Pain Measurement

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Germany
  • Jena, Germany
    • Jena University Hospital
• Mexico
  • Guadalajara, Mexico
    • Hospital San Javier Guadalajara
  • Mexico City, Mexico
    • Instituto Nacional De Cancerologia
  • Mexico City, Mexico
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Mexico City, Mexico
    • Centro Nacional SIGLO XXI (IMSS)
  • Mexico City, Mexico
    • Hospital Angeles Interlomas CDMX
  • Mexico City, Mexico
    • Hospital de traumatologia y Ortopedia Lomas Verdes (IMSS)
  • Mexico City, Mexico
    • Hospital fundación Medica Sur
  • Mexico City, Mexico
    • Hospital General de Villacoapa (IMSS)
  • Mexico City, Mexico
    • Hospital Ruben Leñero
  • Mexico City, Mexico
    • Instituto Nacional de Enfermedades Respiratorias Cosio Villegas (INER)
  • Puebla, Mexico
    • Hospital Angeles Puebla
  • San Luis Potosi, Mexico
    • Hospital Central Morones Prieto San Luis Potosi
  • Cdmx
    • Mexico City, Cdmx, Mexico
      • Hospital Central Militar
  • Chihuahua
    • El Bajo, Chihuahua, Mexico
      • Hospital General de Chihuahua Salvador Zubirán Anchondo
  • Guanajuato
    • León, Guanajuato, Mexico
      • Hospital Aranda de La Parra (Leon Guanajuato)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients after surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	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.	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.	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.	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.	Day 7 after surgery and 1 Month after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory regression analysis for improving understanding of pain interference on day 7 after surgery	Exploratory regression analysis for pain interference on postoperative day 7 (BPI-PITS, dependent variable), demographic variables, perioperative treatment variables and patient-reported outcomes (International Pain Out Questionnaire) from the first post-operative day (POD1).	First postoperative day and postoperative day 7
Exploratory regression analysis for improving understanding of pain intensity on postoperative day 7.	Exploratory regression analysis for pain intensity on postoperative day 7 (BPI-PSVS, dependent variable). Independent variables will include demographic variables, perioperative treatment variables and patient-reported outcomes obtained on the first postoperative day (POD1)	First postoperative day and postoperative day 7
Exploratory regression analysis for improving understanding of pain intensity at POM1	Exploratory regression analysis for pain intensity at POM1 (BPI-PSVS, dependent variable). Independent variables will include: demographic variables, perioperative treatment variables and patient reported outcomes (International Pain Out Questionnaire) from the first postoperative day (POD1).	First postoperative day and 1 month after surgery

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Collaborators: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Hospital Central "Dr. Ignacio Morones Prieto"; Instituto Nacional de Cancerologia de Mexico; Instituto Nacional de Enfermedades Respiratorias; Fundación Clínica Médica Sur; Hospital Angeles Lomas; Hospital Central Militar; Hospital General Dr. Ruben Leñero; 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 San Javier Guadalajara; Hospital Aranda de La Parra (Leon Guanajuato); Hospital General Regional Número 2 Dr. Guillermo Fajardo Ortiz
• Investigators: Principal Investigator: 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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): December 31, 2030
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain, Postoperative; Neuralgia
• Other Study ID Numbers: JenaUH_pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data collected by each hospital belongs to them.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No