Validation of Predictive Scale of Chronic Postsurgical Pain

Sponsor

Parc de Salut Mar (Other)

Overall Status

Unknown status

CT.gov ID

NCT02991287

Collaborator

(none)

1,040

Enrollment

Locations

33.9

Duration (Months)

49.5

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To asses the precision of a score to predict chronic post surgical pain in patients undergoing inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy. Prospective multicenter cohort study in 21 hospital in spain.

Condition or Disease	Intervention/Treatment	Phase
Chronic Postoperative Pain	Procedure: Inguinal hernia repair Procedure: Abdominal hysterectomy Procedure: Vaginal hysterectomy Procedure: Thoracotomy

Study Design

Study Type:

Observational

Anticipated Enrollment :

1040 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective External Validation of a Predictive Scale of Chronic Postsurgical Pain

Study Start Date :

Feb 1, 2017

Anticipated Primary Completion Date :

Feb 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Chronic post-surgical pain patients Patients scheduled for differents types of surgery (inguinal, hernia repair, abdominal hysterectomy, vaginal hysterectomy, and thoracotomy).	Procedure: Inguinal hernia repair Procedure: Abdominal hysterectomy Procedure: Vaginal hysterectomy Procedure: Thoracotomy

Arm

Intervention/Treatment

Chronic post-surgical pain patients

Patients scheduled for differents types of surgery (inguinal, hernia repair, abdominal hysterectomy, vaginal hysterectomy, and thoracotomy).

Procedure: Inguinal hernia repair

Procedure: Abdominal hysterectomy

Procedure: Vaginal hysterectomy

Procedure: Thoracotomy

Outcome Measures

Primary Outcome Measures

GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12). [After evaluation of chronic postsurgical pain 4th month after the end of surgery]
GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12) to identify patients that could develop chronic post surgical pain after inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy.

Secondary Outcome Measures

Verbal rating scale [After evaluation of chronic postsurgical pain 4th month after the end of surgery]
Prevalence of chronic post surgical pain after inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy will be assessed by verbal rating scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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), abdominal hysterectomy, vaginal hysterectomy and 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 de Badalona	Badalona	Barcelona	Spain	08911
2	Hospital Germans Tries i Pujol	Badalona	Barcelona	Spain	08916
3	Hospital de Bellvitge	Hospitalet de Llobregat	Barcelona	Spain	08907
4	Hospital de Mataró	Mataro	Barcelona	Spain	08304
5	Hospital Parc Taulí	Sabadell	Barcelona	Spain	08208
6	Hospital de Terrassa	Terrassa	Barcelona	Spain	08227
7	Hospital de Cruces	Baracaldo	Bizcaia	Spain	48903
8	Hospital Son Espases	Palma de Mallorca	Palma	Spain	07120
9	Hospital Son Llatzer	Palma de Mallorca	Palma	Spain	07198
10	Hospital General de Alicante	Alicante	Valencia	Spain	03010
11	Hospital del Mar	Barcelona		Spain	08003
12	Hospital de Sant Pau	Barcelona		Spain	08026
13	Hospital de la Vall d'Hebrón	Barcelona		Spain	08035
14	Hospital de Sant Rafael	Barcelona		Spain	08035
15	Hospital de Galdakao	Bizkaia		Spain	48960
16	Hopsital Gregorio Marañon	Madrid		Spain	28007
17	Hospital 12 de Octubre	Madrid		Spain	28041
18	Hospital Nuestra Señora de Valme	Sevilla		Spain	41014
19	Hospital Universitario La Fe	Valencia		Spain	46026
20	Hospital Lluís Alcanyís de Xàtiva	Valencia		Spain	46800
21	Hospital de Valladolid	Valladolid		Spain	47003

Sponsors and Collaborators

Parc de Salut Mar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Antonio Montes, Anesthesiologyst, PhD., Parc de Salut Mar

ClinicalTrials.gov Identifier:

NCT02991287

Other Study ID Numbers:

PI16/00279

First Posted:

Dec 13, 2016

Last Update Posted:

Dec 13, 2016

Last Verified:

Dec 1, 2016

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Dec 13, 2016