Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606067
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Duloxetine to Prevent Chronic Postsurgical Pain After Inguinal Hernia Repair in Patients at High Risk
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Perioperative Duloxetine in Patients at High Risk for Developing Chronic Postsurgical Pain After Inguinal Hernia Repair a Multicenter Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GENDOLCAT3
Brief Summary:
The clinical trial will be conducted in 14 Spanish hospitals It is estimated based on our previous studies that 2855 patients scheduled for elective inguinal hernia surgery will have to be assessed to detect patients with 27 level of risk for Chronic Post-Surgical Pain CPSP These high-risk patients will be randomized to 2 treatment groups one will receive duloxetine for 2 weeks prior to surgery and 1 week after surgery intervention group and the other the placebo control group during the same periods The primary outcome will be a 50 decrease in the CPSP incidence in the intervention group compared to the placebo group 4 months after surgery
Detailed Description:
Prospective multicenter double-blind randomized double-blind controlled trial In the first phase the investigators use the Chronic Post-Surgical Pain CPSP risk model to select patients scheduled for inguinal hernia repair with a 27 level of risk for CPSP
A total of 2855 patients will be screened in 14 Spanish hospitals Hospital del Mar Barcelona Hospital Germans Trias i Pujol Badalona H Vall dHebrón Barcelona Hospital de Bellvitge Barcelona Hospital de Cruces Bilbao Hospital 12 de Octubre Madrid Hospital de Valme Sevilla Hospital de Son Espases Palma de Mallorca Hospital Son Llatzer Palma de Mallorca Hospital General de Valladolid Valladolid Hospital General de Alicante Alicante Hospital Lluís Alcanyís de Xativa
The high-risk patients will be randomized to 2 treatment groups to receive 30 mgd of duloxetine for 2 weeks prior to surgery and 1 week after surgery intervention group or placebo control group during the same periods
The primary outcome will be a decrease in the CPSP incidence at 4 months in the intervention group compared to the placebo group with an odds ratio of 044 as the effect size The investigators estimate that it will be necessary to treat 294 participants 147 in each group Participants that might have CPSP will be detected in follow-up telephone interviews approximately 3 months after surgery Participants who report pain at that time will be scheduled for an appointment at their hospitals pain clinic to confirm the CPSP diagnosis by exhaustive physical examination and to assess pain intensity characteristics and degree of interference with daily living
A total of 2855 patients will be screened in 14 Spanish hospitals Hospital del Mar Barcelona Hospital Germans Trias i Pujol Badalona H Vall dHebrón Barcelona Hospital de Bellvitge Barcelona Hospital de Cruces Bilbao Hospital 12 de Octubre Madrid Hospital de Valme Sevilla Hospital de Son Espases Palma de Mallorca Hospital Son Llatzer Palma de Mallorca Hospital General de Valladolid Valladolid Hospital General de Alicante Alicante Hospital Lluís Alcanyís de Xativa
The high-risk patients will be randomized to 2 treatment groups to receive 30 mgd of duloxetine for 2 weeks prior to surgery and 1 week after surgery intervention group or placebo control group during the same periods
The primary outcome will be a decrease in the CPSP incidence at 4 months in the intervention group compared to the placebo group with an odds ratio of 044 as the effect size The investigators estimate that it will be necessary to treat 294 participants 147 in each group Participants that might have CPSP will be detected in follow-up telephone interviews approximately 3 months after surgery Participants who report pain at that time will be scheduled for an appointment at their hospitals pain clinic to confirm the CPSP diagnosis by exhaustive physical examination and to assess pain intensity characteristics and degree of interference with daily living
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None