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

Sponsor

Fundacion IMIM (Other)

Overall Status

Completed

CT.gov ID

NCT01510496

Collaborator

(none)

3,979

Enrollment

Locations

65.9

Duration (Months)

153

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Postoperative Pain	Procedure: Inguinal herniorraphy. Procedure: Hysterectomy. Procedure: Thoracotomy .

Study Design

Study Type:

Observational

Actual Enrollment :

3979 participants

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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	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).

Arm

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).

Outcome Measures

Primary Outcome Measures

Evaluation of chronic postsurgical pain. [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.

Secondary Outcome Measures

Predictive factors of chronic postsurgical pain. [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital Municipal de Badalona	Badalona	Barcelona	Spain	08911
2	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
3	Hospital de San Bernabé	Berga	Barcelona	Spain	08600
4	Hospital de Granollers	Granollers	Barcelona	Spain	08400
5	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona	Spain	08907
6	Hospital General de Manresa	Manresa	Barcelona	Spain	08240
7	Hospital de Mataro	Mataro	Barcelona	Spain	08304
8	Hospital Parc Tauli	Sabadell	Barcelona	Spain	08208
9	Hospital Mutua de Terrassa	Terrassa	Barcelona	Spain	08221
10	Hospital Universitari Mutua de Terrassa	Terrassa	Barcelona	Spain	08227
11	Hospital de Viladecans	Viladecans	Barcelona	Spain	08840
12	Hospital de Santa Caterina	Salt	Girona	Spain	17190
13	Hospital Sant Joan de Reus	Reus	Tarragona	Spain	43201
14	Hospital Lluís Alcanyís de Xàtiva	Xàtiva	València	Spain	46800
15	Hospital del Mar	Barcelona		Spain	08003
16	Hospital de l'Esperança	Barcelona		Spain	08024
17	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025
18	Hospital Sagrat Cor	Barcelona		Spain	08029
19	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
20	Hospital Clínic i Provincial de Barcelona	Barcelona		Spain	08036
21	Hospital del Sant Boi	Barcelona		Spain	08830
22	Hospital Universitari Doctor Josep Trueta de Girona	Girona		Spain	17007
23	Hospital Santa Maria	Lleida		Spain	25198
24	Hospital Clínico de Valencia	Valencia		Spain	46010
25	Hospital General Universitario de Valencia	Valencia		Spain	46014
26	Hospital Universitari de la Fe	Valencia		Spain	46026