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Chronic PainNCT03881124

Pain Trajectories in Severe Persistent Inguinal Post-herniorrhaphy Pain

An observational study of Chronic Pain, run by University of Copenhagen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Severe persistent postsurgical pain (PPP) remains a major healthcare challenge. In the third most common surgical procedure in the UK, inguinal herniorrhaphy, including 85,000 surgeries in 2015, an estimated 1,500 to 3,000 patients will annually develop severe PPP. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Pain
How many people
95 participants
Where
No sites listed yet
Study dates
21 Aug 2014to 10 Nov 2016
Phase
Observational
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with severe persistent pain after groin hernia repair with psychophysical disability referred to a dedicated tertiary center on a nationwide basis.

Who may be able to join

  • Patients with severe persistent pain (>6 mo) after groin hernia repair referred to our center for PPP

Who cannot join

  • Unable to cooperate with the sensory examinations

About this study

Severe persistent postsurgical pain (PPP) remains a major healthcare challenge. In the third most common surgical procedure in the UK, inguinal herniorrhaphy, including 85,000 surgeries in 2015, an estimated 1,500 to 3,000 patients will annually develop severe PPP. While the trajectory of PPP is generally considered a continuation of the acute post-surgery pain, recent data suggest the condition may develop with a delayed onset. The present study evaluated pain-trajectories in a consecutive cohort referred to a tertiary PPP-center. Explanatory variables based on individual psychometric, sensory and surgical profiles were analysed.

Read the detailed description

Severe persistent post-surgical pain (PPP) is a prevalent medical problem leading to impairment of physical and psycho-social functions in a large number of individuals.Severe PPP may significantly influence 4-8% of the surgical population, depending primarily on the surgical procedure and technique, but also patient-related pre-surgical factors.Updated criteria for PPP have recently been suggested. Inguinal herniorrhaphy qualifies for PPP-research due to a high surgical volume. Paradoxically, while the surgery is considered a minor procedure with limited tissue damage it is carried out in a territory with abundant nerve and vascular supply, and, complex musculoskeletal functions essential for locomotor actions. Persistent pain after inguinal herniorrhaphy may develop after a seemingly successful surgical procedure, and, is seen in a severe form in 2-4% of the patients associated with significant deterioration of the health-related quality of life.

The transition process from acute to persistent pain may be more complex than previously assumed, making the study of temporal pain trajectories interesting. Based on clinical experience from a nationwide research center in PPP following inguinal herniorrhaphy, the authors decided first, to perform a prospective exploratory cohort study examining graphical pain charts by planimetrics, attempting to construct a valid statistical sub-classification of the trajectories. Secondly, the relationship between the sub-classification of the trajectories, and, potential explanatory variables, based on individual profiles of pain, psychometrics, quantitative sensory testing, and surgical procedures, were analysed, using principal component analysis and logistic regression models.

Conditions
Chronic Pain
Keywords
Inguinal Herniorrhaphy, Hernia, Persistent postsurgical pain, Long term follow up, Quantitative sensory testing (QST), Pain trajectory, Explanatory variables
Medical subject headings
Chronic Pain, Hernia, Pain, Postoperative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Group I pain trajectories

    Trajectories are examined by area-under-curve using normalized pain intensities (numeric rating scale values 0-10 [y-axis]) and normalized time points (years [x-axis]) in patients with sustained severe where the acute post-surgical pain continued into persistent post-surgical pain (PPP) with unchanged high-intensity pain

    Measured: 2014-2016

  2. Group II pain trajectories

    Trajectories are examined by area-under-curve using normalized pain intensities (numeric rating scale values 0-10 [y-axis]) and normalized time points (years [x-axis]) in patients where the acute post-surgical pain decreased significantly to low-intensity levels, but pain recurred developing into high-intensity PPP

    Measured: 2014-2016

  3. Group III pain trajectories

    Trajectories are examined by area-under-curve using normalized pain intensities (numeric rating scale values 0-10 [y-axis]) and normalized time points (years [x-axis]) in patients where repeat-surgery precipitated high-intensity PPP

    Measured: 2014-2016

  4. Group IV pain trajectories

    Trajectories are examined by area-under-curve using normalized pain intensities (numeric rating scale values 0-10 [y-axis]) and normalized time points (years [x-axis]) in patients where pre-surgical high-intensity pain continued unchanged post-surgically.

    Measured: 2014-2016

Secondary outcomes (7)

  1. Pain intensity

    Numeric Rating Scale (NRS; 0-10 units)

    Measured: 2014-2016

  2. Activity of Daily Living (ADL) score

    Activities Assessment Scale (AAS; 8 specified physical activities; 0-8 units each)

    Measured: 2014-2016

  3. Assessments of Anxiety and Depression

    Hospital Anxiety and Depression Scale (HADS; 14 items scale; 0-21 units)

    Measured: 2014-2016

  4. Assessment of Pain Catastrophizing

    Pain Catastrophizing Scale (PCS; 13 item scale; 0-65 units)

    Measured: 2014-2016

  5. Quantitative sensory testing (QST)

    Mechanical and thermal detection and pain thresholds

    Measured: 2014-2016

  6. painDETECT

    Neuropathic pain questionnaire (15 items scale; 0-38 points; 0-12 points = neuropathic pain unlikely; 13-18 = existence of neuropathic pain cannot unambigously be rejected;19-38 points = neuropathic pain likely)

    Measured: 2014-2016

  7. S-LANSS

    Neuropathic pain questionnaire (7 items; minimal cumulated score 0 points, maximum cumulated score 24 points; a score of 12 or more suggests pain of predominantly neuropathic origin)

    Measured: 2014-2016

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2019
  2. Study start21 Aug 2014
  3. Primary completion10 Nov 2016
  4. Study completion10 Nov 2016

Resources

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
Retrospective
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03881124
Sponsor's protocol ID
H-2-2011-023-TRJ
Status last verified
Feb 2024
First submitted
14 Mar 2019
Last updated
22 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be made available as a supplement to the published scientific article.

Publications

  • Chapman CR, Vierck CJ. The Transition of Acute Postoperative Pain to Chronic Pain: An Integrative Overview of Research on Mechanisms. J Pain. 2017 Apr;18(4):359.e1-359.e38. doi: 10.1016/j.jpain.2016.11.004. Epub 2016 Nov 28.

    PubMed 27908839

  • Pogatzki-Zahn EM, Segelcke D, Schug SA. Postoperative pain-from mechanisms to treatment. Pain Rep. 2017 Mar 15;2(2):e588. doi: 10.1097/PR9.0000000000000588. eCollection 2017 Mar.

    PubMed 29392204

  • Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.

    PubMed 16698416

  • Werner MU, Bischoff JM. Persistent postsurgical pain: evidence from breast cancer surgery, groin hernia repair, and lung cancer surgery. Curr Top Behav Neurosci. 2014;20:3-29. doi: 10.1007/7854_2014_285.

    PubMed 24523139

  • Werner MU, Kongsgaard UE. I. Defining persistent post-surgical pain: is an update required? Br J Anaesth. 2014 Jul;113(1):1-4. doi: 10.1093/bja/aeu012. Epub 2014 Feb 18. No abstract available.

    PubMed 24554546

  • Werner MU. Management of persistent postsurgical inguinal pain. Langenbecks Arch Surg. 2014 Jun;399(5):559-69. doi: 10.1007/s00423-014-1211-9. Epub 2014 May 23.

    PubMed 24849039

  • Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.

    PubMed 19903919

  • Reinpold WM, Nehls J, Eggert A. Nerve management and chronic pain after open inguinal hernia repair: a prospective two phase study. Ann Surg. 2011 Jul;254(1):163-8. doi: 10.1097/SLA.0b013e31821d4a2d.

    PubMed 21562403

  • McCarthy M Jr, Jonasson O, Chang CH, Pickard AS, Giobbie-Hurder A, Gibbs J, Edelman P, Fitzgibbons R, Neumayer L. Assessment of patient functional status after surgery. J Am Coll Surg. 2005 Aug;201(2):171-8. doi: 10.1016/j.jamcollsurg.2005.03.035.

    PubMed 16038812

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain, run by University of Copenhagen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Group I pain trajectories (time frame: 2014-2016). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03881124, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.

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