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Completed

NCT Number: NCT02237963

Influence of the Surgical Approach on the Development of a Chronic Pain After Thoracic Surgery

The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on the surgical approach. The posterolateral approach is compared to the axillary approach especially in term of development of a chronic pain.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Foch

Suresnes, 92151, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing thoracic surgery intervention by posterolateral or axillary thoracotomy, having no exclusion criteria for the study,

Exclusion criteria

  • planned surgery by thoracoscopy or extended surgery,
  • mental disability,
  • vulnerable person within the meaning of French law,
  • inability to communicate by phone,
  • poor understanding of French.

Treatment and study plan

Posterolateral thoracotomy

Procedure

Axillary thoracotomy

Procedure

Primary outcomes

  1. Chronic pain

    Time frame: 4 months

    Prevalence of pain 4 months after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain)

Secondary outcomes

  1. Early postoperative pain

    Time frame: 7 days

    Evolution of pain from postoperative day 1 to postoperative day 6 ("pain trajectory") Prevalence of pain 5 to 7 days after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain).

    Clinical examination to detect modification of skin sensibility

  2. Characteristics of chronic pain

    Time frame: 4 months

    Characteristics are notably:

    • its localization and intensity,
    • its neuropathic origin,
    • its impact on daily life,
    • required analgesic treatment,
    • need for a specific pain consultation

  3. Quality of life

    Time frame: 4 months

    Specific questionnaire

  4. Catastrophism

    Time frame: 4 months

    Score of Sullivan

  5. Anxiety

    Time frame: 4 months

    Stai trait

  6. Preventive role of epidural analgesia

    Time frame: 4 months

    Proportion of patients with chronic pain in each cohort who had had a postoperative thoracic epidural analgesia

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: IncisionPain

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 12, 2014
Registry last updated
Oct 31, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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