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Completed

NCT Number: NCT03881124

Pain Trajectories in Severe Persistent Inguinal Post-herniorrhaphy Pain

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unable to cooperate with the sensory examinations

Treatment and study plan

Primary outcomes

  1. Group I pain trajectories

    Time frame: 2014-2016

    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

  2. Group II pain trajectories

    Time frame: 2014-2016

    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

  3. Group III pain trajectories

    Time frame: 2014-2016

    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

  4. Group IV pain trajectories

    Time frame: 2014-2016

    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.

Secondary outcomes

  1. Pain intensity

    Time frame: 2014-2016

    Numeric Rating Scale (NRS; 0-10 units)

  2. Activity of Daily Living (ADL) score

    Time frame: 2014-2016

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

  3. Assessments of Anxiety and Depression

    Time frame: 2014-2016

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

  4. Assessment of Pain Catastrophizing

    Time frame: 2014-2016

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

  5. Quantitative sensory testing (QST)

    Time frame: 2014-2016

    Mechanical and thermal detection and pain thresholds

  6. painDETECT

    Time frame: 2014-2016

    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)

  7. S-LANSS

    Time frame: 2014-2016

    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)

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 19, 2019
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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