Clinical trial NCT02991287: Validation of Predictive Scale of Chronic Postsurgical Pain
Official title: Prospective External Validation of a Predictive Scale of Chronic Postsurgical Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Postoperative Pain
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: After evaluation of chronic postsurgical pain 4th month after the end of surgery
Secondary outcomes:
measure: Verbal rating scale
timeFrame: After evaluation of chronic postsurgical pain 4th month after the end of surgery
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital de Badalona
state: Barcelona
city: Badalona
country: Spain
facility: Hospital Germans Tries i Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Mataro
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital de Terrassa
state: Barcelona
city: Baracaldo
country: Spain
facility: Hospital de Cruces
state: Bizcaia
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Palma
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Palma
city: Alicante
country: Spain
facility: Hospital General de Alicante
state: Valencia
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Hospital de la Vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospital de Sant Rafael
city: Bizkaia
country: Spain
facility: Hospital de Galdakao
city: Madrid
country: Spain
facility: Hopsital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Sevilla
country: Spain
facility: Hospital Nuestra Señora de Valme
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valencia
country: Spain
facility: Hospital Lluís Alcanyís de Xàtiva
city: Valladolid
country: Spain
facility: Hospital de Valladolid
Study officials:
References:
citation: 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.