Transition From Acute to Chronic Pain After Inguinal Hernia, Hysterectomy and Thoracotomy: Analysis of Risk Factors and Association With Genetic Polymorphisms

Chronic Postoperative Pain Clinical Trial

Official title:

Transition From Acute to Chronic Pain After Inguinal Hernia, Hysterectomy and Thoracotomy : Analysis of Risk Factors and Association With Genetic Polymorphisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510496
• Other study ID #: GENDOLCAT
• Status: Completed
• Phase: N/A
• First received: December 23, 2011
• Last updated: December 29, 2015
• Start date: January 2009
• Est. completion date: July 2014

Study information

• Verified date: December 2015
• Source: Fundacion IMIM
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The treatment of postoperative pain continues to be inadequate in the investigators practice setting.

Inadequate pain treatment not only contributes to postoperative complications in the short term but can also be a factor that favors the development of chronic postoperative pain and diminishes long-term quality of life. Risk factors that can lead to a transition to chronic pain need to be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3979
• Est. completion date: July 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with given inform consent, aged mor than 18 years, who undergo scheduled surgery of one of the following types: inguinal hernia (men), hysterectomy, thoracotomy (men).

Exclusion Criteria:

• Patients aged less than 18 years,

• Patients requiring reoperation because of surgical complications.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Postoperative Pain
• Hernia, Inguinal
• Pain, Postoperative

Intervention

Procedure:
• Inguinal herniorraphy.
Inguinal herniorraphy (non laparoscopic).
• Hysterectomy.
Hysterectomy: Vaginal and abdominal.
• Thoracotomy .
Thoracotomy (non laparoscopic).

Locations

Country	Name	City	State
Spain	Hospital Municipal de Badalona	Badalona	Barcelona
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona
Spain	Hospital de l'Esperança	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital del Sant Boi	Barcelona
Spain	Hospital Sagrat Cor	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital de San Bernabé	Berga	Barcelona
Spain	Hospital Universitari Doctor Josep Trueta de Girona	Girona
Spain	Hospital de Granollers	Granollers	Barcelona
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Santa Maria	Lleida
Spain	Hospital General de Manresa	Manresa	Barcelona
Spain	Hospital de Mataro	Mataro	Barcelona
Spain	Hospital Sant Joan de Reus	Reus	Tarragona
Spain	Hospital Parc Tauli	Sabadell	Barcelona
Spain	Hospital de Santa Caterina	Salt	Girona
Spain	Hospital Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital Universitari Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital Universitari de la Fe	Valencia
Spain	Hospital de Viladecans	Viladecans	Barcelona
Spain	Hospital Lluís Alcanyís de Xàtiva	Xàtiva	València

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion IMIM

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of chronic postsurgical pain.	After 3 months a physical examination will take place and after 12 months a follow-up will be reported by phone.	After 3 and 12 months of surgery.	No
Secondary	Predictive factors of chronic postsurgical pain.	Preoperative (psychological factors, preoperative pain, pharmacologic treatment) intraoperative (surgical technic, type of anaestesia) and postoperative(posoperative pain, surgical complications and treatment of postoperative pain).	After 3 and 12 months of surgery.	Yes