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

December 29, 2015 updated by: Antonio Montes, Fundacion IMIM

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3979

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of chronic postsurgical pain.
Time Frame: After 3 and 12 months of surgery.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive factors of chronic postsurgical pain.
Time Frame: After 3 and 12 months of surgery.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion IMIM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

December 23, 2011

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimate)

January 16, 2012

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GENDOLCAT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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