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

Completed

• Conditions: Pain, Postoperative
• Interventions: Procedure: Axillary thoracotomy; Procedure: Posterolateral thoracotomy

• Registration Number: NCT02237963
• Lead Sponsor: Hopital Foch

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-12
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Axillary thoracotomy	Axillary thoracotomy	Surgeons perform an axillary thoracotomy
Posterolateral thoracotomy	Posterolateral thoracotomy	Surgeons perform a posterolateral thoracotomy

Primary Outcome Measures

Name	Time	Method
Chronic pain	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 Outcome Measures

Name	Time	Method
Characteristics of chronic pain	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
Quality of life	4 months	Specific questionnaire
Catastrophism	4 months	Score of Sullivan
Early postoperative pain	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
Anxiety	4 months	Stai trait
Preventive role of epidural analgesia	4 months	Proportion of patients with chronic pain in each cohort who had had a postoperative thoracic epidural analgesia

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France