Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-29 @ 1:20 PM
Study NCT ID:
NCT07160595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefit on Chronic Pain of Early Screening and Management of Patients With Persistent Postoperative Pain at 3 Months
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Study Overview
Official Title:
Benefit on Chronic Pain of Early Screening and Management of Patients With Persistent Postoperative Pain at 3 Months
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DROPS
Brief Summary:
Chronic postoperative pain has an overall incidence of approximately 30%, with 5% to 10% of cases classified as severe (numerical rating scale \> 6/10). However, its management remains suboptimal, primarily due to underdiagnosis and delayed referral of patients to specialized chronic pain centers.
Improving the screening of patients with chronic postoperative pain is therefore crucial. Our research has shown that early detection of postoperative neuropathic pain is possible using just two text messages (SMS), as early as three months after surgery. Early screening, combined with prompt management, can prevent pain from becoming chronic and mitigate its harmful effects.
Study design
This study is a cluster crossover randomized trial. All participating centers (n=16) will take part in two sequential study periods:
* Control Period: "Without early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive treatment at 6 months. This reflects the current standard of care for patients with postoperative pain.
* Intervention Period: "With early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive early treatment starting at 3 months.
Study Population
The study will include patients undergoing the following minor surgical procedures:
* Inguinal hernia repair
* Breast reduction
* Mastectomy with lymph node dissection
* Knee arthroscopy
* Knee ligament reconstruction
Study Schedule Recruitment Period: 24 months Patient Follow-up: 6 months Total Estimated Study Duration: 30 months
Improving the screening of patients with chronic postoperative pain is therefore crucial. Our research has shown that early detection of postoperative neuropathic pain is possible using just two text messages (SMS), as early as three months after surgery. Early screening, combined with prompt management, can prevent pain from becoming chronic and mitigate its harmful effects.
Study design
This study is a cluster crossover randomized trial. All participating centers (n=16) will take part in two sequential study periods:
* Control Period: "Without early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive treatment at 6 months. This reflects the current standard of care for patients with postoperative pain.
* Intervention Period: "With early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive early treatment starting at 3 months.
Study Population
The study will include patients undergoing the following minor surgical procedures:
* Inguinal hernia repair
* Breast reduction
* Mastectomy with lymph node dissection
* Knee arthroscopy
* Knee ligament reconstruction
Study Schedule Recruitment Period: 24 months Patient Follow-up: 6 months Total Estimated Study Duration: 30 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ID RCB | OTHER | 2025-A01249-40 | View |