Validation of Predictive Scale of Chronic Postsurgical Pain

Chronic Postoperative Pain Clinical Trial

Official title:

Prospective External Validation of a Predictive Scale of Chronic Postsurgical Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02991287
• Other study ID #: PI16/00279
• Status: Not yet recruiting
• Phase: N/A
• First received: December 5, 2016
• Last updated: December 9, 2016
• Start date: February 2017
• Est. completion date: December 2019

Study information

• Verified date: December 2016
• Source: Parc de Salut Mar
• Contact: Antonio Montes, PhD
• Phone: 0034932483000
• Email: amontes[@]parcdesalutmar.cat
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1040
• Est. completion date: December 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Pain, Postoperative

Intervention

Procedure:
• Inguinal hernia repair

• Abdominal hysterectomy

• Vaginal hysterectomy

• Thoracotomy

Locations

Country	Name	City	State
Spain	Hospital General de Alicante	Alicante	Valencia
Spain	Hospital de Badalona	Badalona	Barcelona
Spain	Hospital Germans Tries i Pujol	Badalona	Barcelona
Spain	Hospital de Cruces	Baracaldo	Bizcaia
Spain	Hospital de la Vall d'Hebrón	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital de Sant Rafael	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital de Galdakao	Bizkaia
Spain	Hospital de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hopsital Gregorio Marañon	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital de Mataró	Mataro	Barcelona
Spain	Hospital Son Espases	Palma de Mallorca	Palma
Spain	Hospital Son Llatzer	Palma de Mallorca	Palma
Spain	Hospital Parc Taulí	Sabadell	Barcelona
Spain	Hospital Nuestra Señora de Valme	Sevilla
Spain	Hospital de Terrassa	Terrassa	Barcelona
Spain	Hospital Lluís Alcanyís de Xàtiva	Valencia
Spain	Hospital Universitario La Fe	Valencia
Spain	Hospital de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	After evaluation of chronic postsurgical pain 4th month after the end of surgery	No
Secondary	Verbal rating scale	Prevalence of chronic post surgical pain after inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy will be assessed by verbal rating scale.	After evaluation of chronic postsurgical pain 4th month after the end of surgery	No