Pain Intensity After RObotic Assisted Urological Surgery

Study Overview
=================
Brief Summary
-----------------
Postoperative pain remains a widespread but still underestimated problem. Studies have shown that despite improvements in pain management, many patients still suffer from moderate to severe postoperative pain. Severe pain is associated with decreased patient satisfaction, delayed postoperative ambulation, prolonged length of stay, risk of developing chronic postoperative pain, and increased morbidity and mortality. Therefore, it is of great importance that surgical procedures that result in severe pain and the optimal analgesic strategies for these procedures can be identified. Most recommendations on postoperative pain management (prevention and treatment) are not procedure-specific. However, risk factors for postoperative pain depend on the patient and the procedure. In order to develop procedure-specific postoperative pain management guidelines, pain must be assessed in a procedure-specific manner. Additionally, data is sparse on relatively new procedures like robotic surgery. A study, Harel et al. compared pain intensities after ureteral reimplantation with robotic or open surgery in children and reported lower pain scores after robotic surgery. This single study reinforces the clinical findings that robotic surgery is associated with less pain. However, pain assessment after robotic urologic surgery has not been evaluated before. In order to add to the evaluation of postoperative pain in different surgical groups, we wish to evaluate pain intensities after robot-assisted urological surgery. In this cohort study, we seek to provide an estimate of the pain intensities that can be expected after most types of robot-assisted urological surgery in relation to analgesic treatment.

Official Title
-----------------
Pain Intensity After RObotic Assisted Urological Surgery: the PAIROU Study

Conditions
-----------------
Robot-assisted Urological Surgery

Intervention / Treatment
-----------------
* Procedure: Robot-assisted urological surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > or = 18 years old Programmed robot-assisted urological surgery Patient who did not declare any opposition to participating in the study Exclusion Criteria: Urgent surgery Impossibility of communicating in French Cognitive deficit Adults legally protected or deprived of liberty

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robot-assisted urological surgery<br>Patients with programmed robot-assisted urological surgery | Procedure: Robot-assisted urological surgery<br>* Patient with programmed robot-assisted urological surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level on D1 of surgery | Measurement of pain intensity on D1 of surgery, assessed with a simple numerical scale (ENS). Scores range from 0-10 points, with higher scores indicating greater pain intensity. | Day 1 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity (NRS) at rest and during exercise | Pain intensity on the second day after surgery (NRS) at rest and during exercise. Pain intensity assessed with a simple numerical scale (ENS). Scores range from 0-10 points, with higher scores indicating greater pain intensity. | Second day after surgery | 
| Highest pain score at rest and during exercise | Highest pain score in the first 48 hours at rest and during exercise. Pain intensity assessed with a simple numerical scale (ENS). Scores range from 0-10 points, with higher scores indicating greater pain intensity. | In the first 48 hours | 
| Presence of side effect: Nausea and vomiting | Patient presenting or not nausea and vomiting in the first 48 hours | In the first 48 hours | 
| Time of the first ambulation | Time from robotic assisted urological surgery to the first ambulation | Time of the first ambulation during hospitalization | 
| Date and time of resumption of transit | number of days between robotic assisted urological surgery and resumption of transit | Date and time of resumption of transit | 
| Consumption of morphine | Consumption of morphine (or equivalent (see morphine equivalent table)) in mg 48 hours after surgery | During the 48 hours after surgery | 
| Duration of surgery | Duration of surgery: time between the begining of the robotic assisted urological surgery and the end of surgery. | Duration of surgery | 
| Operator experience for the robotic assisted urological surgery | Operator experience for the robotic assisted urological surgery, classified in 3 ranges: less than 5 years; between 5 and 10 years; more than 10 years | Operator experience is the number of years from the first robotic assisted urological surgery performed by the operator until the surgery of the patient included in this study. | 
| Complications | Complications according to the Dindo and Clavien classification | Period is defined from the day of robotic assisted urological surgery until the end of hospitalisation | 
| Length of stay | Length of stay at hospital (number of days) | From the first day of hospitalization to the last day of hospitalization |