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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fundacion IMIM
ClinicalTrials.gov Identifier:
NCT01510496
First received: December 23, 2011
Last updated: January 11, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Postoperative Pain
 Procedure: Inguinal herniorraphy.
Procedure: Hysterectomy.
Procedure: Thoracotomy .

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transition From Acute to Chronic Pain After Inguinal Hernia, Hysterectomy and Thoracotomy : Analysis of Risk Factors and Association With Genetic Polymorphisms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fundacion IMIM:

Primary Outcome Measures:
  • Evaluation of chronic postsurgical pain. [ Time Frame: After 3 and 12 months of surgery. ] [ Designated as safety issue: No ]
    After 3 months a physical examination will take place and after 12 months a follow-up will be reported by phone.


Secondary Outcome Measures:
  • Predictive factors of chronic postsurgical pain. [ Time Frame: After 3 and 12 months of surgery. ] [ Designated as safety issue: Yes ]
    Preoperative (psychological factors, preoperative pain, pharmacologic treatment) intraoperative (surgical technic, type of anaestesia) and postoperative(posoperative pain, surgical complications and treatment of postoperative pain).


Biospecimen Retention:   Samples With DNA

Sample collection Five milliliters of venous blood will be extracted from each patient with chronic pain; control samples will come from a DNA bank. All patients must have given their written consent to testing and storage.

- Plasma DNA will be extracted with a BioRobot EZ1 Workstation (Qiagen).


Enrollment: 3979
Study Start Date: January 2009
Estimated Study Completion Date: March 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients who had inguinal herniorraphy. Procedure: Inguinal herniorraphy.
Inguinal herniorraphy (non laparoscopic).
Patients who had hysterectomy. Procedure: Hysterectomy.
Hysterectomy: Vaginal and abdominal.
Patients who had thoracotomy. Procedure: Thoracotomy .
Thoracotomy (non laparoscopic).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All spanish patients who undergo scheduled surgery of one of the following types: inguinal herniorrhaphy, hysterectomy, toracothomy.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510496

Locations
Spain
Hospital Municipal de Badalona
Badalona, Barcelona, Spain, 08911
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital de San Bernabé
Berga, Barcelona, Spain, 08600
Hospital de Granollers
Granollers, Barcelona, Spain, 08400
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital General de Manresa
Manresa, Barcelona, Spain, 08240
Hospital de Mataro
Mataro, Barcelona, Spain, 08304
Hospital Parc Tauli
Sabadell, Barcelona, Spain, 08208
Hospital Universitari Mutua de Terrassa
Terrassa, Barcelona, Spain, 08227
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Hospital de Viladecans
Viladecans, Barcelona, Spain, 08840
Hospital de Santa Caterina
Salt, Girona, Spain, 17190
Hospital Sant Joan de Reus
Reus, Tarragona, Spain, 43201
Hospital Lluís Alcanyís de Xàtiva
Xàtiva, València, Spain, 46800
Hospital del Sant Boi
Barcelona, Spain, 08830
Hospital Sagrat Cor
Barcelona, Spain, 08029
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital de l'Esperança
Barcelona, Spain, 08024
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitari Doctor Josep Trueta de Girona
Girona, Spain, 17007
Hospital Santa Maria
Lleida, Spain, 25198
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital Clínico de Valencia
Valencia, Spain, 46010
Hospital Universitari de la Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Fundacion IMIM
  More Information

No publications provided

Responsible Party: Fundacion IMIM
ClinicalTrials.gov Identifier: NCT01510496     History of Changes
Other Study ID Numbers: GENDOLCAT
Study First Received: December 23, 2011
Last Updated: January 11, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Fundacion IMIM:
Chronic pain
genetic polymorphisms
postoperative pain

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pain, Postoperative
Pathological Conditions, Anatomical
Hernia, Abdominal
 Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013