Validation of Predictive Scale of Chronic Postsurgical Pain

• Conditions: Chronic Postoperative Pain
• Interventions: Procedure: Inguinal hernia repair; Procedure: Abdominal hysterectomy; Procedure: Vaginal hysterectomy; Procedure: Thoracotomy

• Registration Number: NCT02991287
• Lead Sponsor: Parc de Salut Mar

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-09
• Last Update Submitted: 2016-12-09
• Study First Posted: 2016-12-13
• Last Update Posted: 2016-12-13
• Study Start: 2017-02
• Primary Completion: 2019-02
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1040

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (21)

Hospital de Badalona; 🇪🇸 Badalona, Barcelona, Spain

Hospital Germans Tries i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital de Mataró; 🇪🇸 Mataro, Barcelona, Spain

Hospital Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital de Cruces; 🇪🇸 Baracaldo, Bizcaia, Spain

Hospital Son Espases; 🇪🇸 Palma de Mallorca, Palma, Spain

Hospital de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Son Llatzer; 🇪🇸 Palma de Mallorca, Palma, Spain

Hospital de la Vall d'Hebrón; 🇪🇸 Barcelona, Spain

Hospital de Sant Rafael; 🇪🇸 Barcelona, Spain

Hospital General de Alicante; 🇪🇸 Alicante, Valencia, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hopsital Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital de Galdakao; 🇪🇸 Bizkaia, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Nuestra Señora de Valme; 🇪🇸 Sevilla, Spain

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Hospital Lluís Alcanyís de Xàtiva; 🇪🇸 Valencia, Spain

Hospital de Valladolid; 🇪🇸 Valladolid, Spain

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain