Validation of Predictive Scale of Chronic Postsurgical Pain

NCT02991287 | Unknown

• 1 other identifier: PI16/00279
• Study Type: observational
• Target: 1,040
• Locations: 1 country
• Sites: 21

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.

Conditions

Chronic Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Verbal rating scale

  After evaluation of chronic postsurgical pain 4th month after the end of surgery

Study Arms (1)

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

Interventions

Inguinal hernia repair PROCEDURE

Chronic post-surgical pain patients

Abdominal hysterectomy PROCEDURE

Chronic post-surgical pain patients

Vaginal hysterectomy PROCEDURE

Chronic post-surgical pain patients

Thoracotomy PROCEDURE

Chronic post-surgical pain patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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), abdominal hysterectomy, vaginal hysterectomy and thoracotomy (men)

You may not qualify if:

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

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (21)

Hospital de Badalona

Badalona, Barcelona, 08911, Spain

Location

Hospital Germans Tries i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital de Sant Pau

Barcelona, Barcelona, 08026, Spain

Location

Hospital de la Vall d'Hebrón

Barcelona, Barcelona, 08035, Spain

Location

Hospital de Sant Rafael

Barcelona, Barcelona, 08035, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Hospital de Cruces

Barakaldo, Bizcaia, 48903, Spain

Location

Hospital de Galdakao

Bizkaia, Bizkaia, 48960, Spain

Location

Hopsital Gregorio Marañon

Madrid, Madrid, 28007, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Son Espases

Palma de Mallorca, Palma, 07120, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Palma, 07198, Spain

Location

Hospital Nuestra Señora de Valme

Seville, Sevilla, 41014, Spain

Location

Hospital General de Alicante

Alicante, Valencia, 03010, Spain

Location

Hospital Universitario La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Lluís Alcanyís de Xàtiva

Valencia, Valencia, 46800, Spain

Location

Hospital de Valladolid

Valladolid, Valladolid, 47003, Spain

Location

Related Publications (1)

• Montes A, Roca G, Cantillo J, Sabate S; GENDOLCAT Study Group. Presurgical risk model for chronic postsurgical pain based on 6 clinical predictors: a prospective external validation. Pain. 2020 Nov;161(11):2611-2618. doi: 10.1097/j.pain.0000000000001945.

  PMID: 32541391 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hysterectomy, Vaginal; Thoracotomy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hysterectomy; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Central Study Contacts

Antonio Montes, PhD

CONTACT

0034932483000; amontes@parcdesalutmar.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologyst, PhD.

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 13, 2016
• Study Start: February 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 13, 2016

Record last verified: 2016-12

Locations

ES (21)