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

Pain, Postoperative Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237963
• Other study ID #: 2013/50
• Secondary ID: 2013- A01641-44
• Status: Completed
• Phase: N/A
• First received: September 9, 2014
• Last updated: October 28, 2016
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Postoperative

Intervention

Procedure:
• Posterolateral thoracotomy

• Axillary thoracotomy

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (1)

Ringsted TK, Wildgaard K, Kreiner S, Kehlet H. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. Clin J Pain. 2013 Sep;29(9):791-9. doi: 10.1097/AJP.0b013e318278d4e2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain	Prevalence of pain 4 months after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain)	4 months	No
Secondary	Early postoperative pain	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	7 days	No
Secondary	Characteristics of chronic pain	Characteristics are notably: its localization and intensity,; its neuropathic origin,; its impact on daily life,; required analgesic treatment,; need for a specific pain consultation	4 months	No
Secondary	Quality of life	Specific questionnaire	4 months	No
Secondary	Catastrophism	Score of Sullivan	4 months	No
Secondary	Anxiety	Stai trait	4 months	No
Secondary	Preventive role of epidural analgesia	Proportion of patients with chronic pain in each cohort who had had a postoperative thoracic epidural analgesia	4 months	No