NCT01510496

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,979

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

3.9 years

First QC Date

December 23, 2011

Last Update Submit

December 29, 2015

Conditions

Keywords

Chronic paingenetic polymorphismspostoperative pain

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Predictive factors of chronic postsurgical pain.

    After 3 and 12 months of surgery.

Study Arms (3)

Patients who had inguinal herniorraphy.

Procedure: Inguinal herniorraphy.

Patients who had hysterectomy.

Procedure: Hysterectomy.

Patients who had thoracotomy.

Procedure: Thoracotomy .

Interventions

Inguinal herniorraphy (non laparoscopic).

Patients who had inguinal herniorraphy.
Hysterectomy.PROCEDURE

Hysterectomy: Vaginal and abdominal.

Patients who had hysterectomy.
Thoracotomy .PROCEDURE

Thoracotomy (non laparoscopic).

Patients who had thoracotomy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • Patients aged less than 18 years,
  • Patients requiring reoperation because of surgical complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Hospital Municipal de Badalona

Badalona, Barcelona, 08911, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital de l'Esperança

Barcelona, Barcelona, 08024, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Sagrat Cor

Barcelona, Barcelona, 08029, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital del Sant Boi

Barcelona, Barcelona, 08830, Spain

Location

Hospital de San Bernabé

Berga, Barcelona, 08600, Spain

Location

Hospital de Granollers

Granollers, Barcelona, 08400, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital General de Manresa

Manresa, Barcelona, 08240, Spain

Location

Hospital de Mataro

Mataró, Barcelona, 08304, Spain

Location

Hospital Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitari Mutua de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Hospital de Viladecans

Viladecans, Barcelona, 08840, Spain

Location

Hospital Universitari Doctor Josep Trueta de Girona

Girona, Girona, 17007, Spain

Location

Hospital de Santa Caterina

Salt, Girona, 17190, Spain

Location

Hospital Santa Maria

Lleida, Lleida, 25198, Spain

Location

Hospital Sant Joan de Reus

Reus, Tarragona, 43201, Spain

Location

Hospital Clínico de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

Location

Hospital Universitari de la Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Lluís Alcanyís de Xàtiva

Xàtiva, València, 46800, Spain

Location

Related Publications (2)

  • Bande D, Molto L, Pereira JA, Montes A. Chronic pain after groin hernia repair: pain characteristics and impact on quality of life. BMC Surg. 2020 Jul 6;20(1):147. doi: 10.1186/s12893-020-00805-9.

  • Montes A, Roca G, Sabate S, Lao JI, Navarro A, Cantillo J, Canet J; GENDOLCAT Study Group. Genetic and Clinical Factors Associated with Chronic Postsurgical Pain after Hernia Repair, Hysterectomy, and Thoracotomy: A Two-year Multicenter Cohort Study. Anesthesiology. 2015 May;122(5):1123-41. doi: 10.1097/ALN.0000000000000611.

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).

MeSH Terms

Conditions

Pain, PostoperativeChronic Pain

Interventions

HysterectomyThoracotomy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 23, 2011

First Posted

January 16, 2012

Study Start

January 1, 2009

Primary Completion

December 1, 2012

Study Completion

July 1, 2014

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations