Pain Trajectories in Severe Persistent Inguinal Post-herniorrhaphy Pain

NCT ID: NCT03881124

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 95 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-21
• Study Completion Date: 2016-11-10

Brief 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. 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

mads u werner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

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Other Identifiers

H-2-2011-023-TRJ

Identifier Type: -

Identifier Source: org_study_id