Pain Intensity After RObotic Assisted Urological Surgery
- Conditions
- Robot-assisted Urological Surgery
- Interventions
- Procedure: Robot-assisted urological surgery
- Registration Number
- NCT05575284
- Lead Sponsor
- Société Française d'Anesthésie et de Réanimation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 968
- Age > or = 18 years old
- Programmed robot-assisted urological surgery
- Patient who did not declare any opposition to participating in the study
- Urgent surgery
- Impossibility of communicating in French
- Cognitive deficit
- Adults legally protected or deprived of liberty
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Robot-assisted urological surgery Robot-assisted urological surgery Patients with programmed robot-assisted urological surgery
- Primary Outcome Measures
Name Time Method Pain level on D1 of surgery Day 1 after 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.
- Secondary Outcome Measures
Name Time Method Time of the first ambulation Time of the first ambulation during hospitalization Time from robotic assisted urological surgery to the first ambulation
Presence of side effect: Nausea and vomiting In the first 48 hours Patient presenting or not nausea and vomiting in the first 48 hours
Highest pain score at rest and during exercise In the first 48 hours 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.
Pain intensity (NRS) at rest and during exercise Second day after surgery 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.
Complications Period is defined from the day of robotic assisted urological surgery until the end of hospitalisation Complications according to the Dindo and Clavien classification
Length of stay From the first day of hospitalization to the last day of hospitalization Length of stay at hospital (number of days)
Date and time of resumption of transit Date and time of resumption of transit number of days between robotic assisted urological surgery and resumption of transit
Consumption of morphine During the 48 hours after surgery Consumption of morphine (or equivalent (see morphine equivalent table)) in mg 48 hours after surgery
Duration of surgery Duration of surgery Duration of surgery: time between the begining of the robotic assisted urological surgery and the end of surgery.
Operator experience for the robotic assisted urological surgery 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. 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
Trial Locations
- Locations (46)
CH Saint Joseph Saint Luc
🇫🇷Lyon, France
Hopital Bicêtre - APHP
🇫🇷Le Kremlin-Bicêtre, France
Groupement des Hôpitaux de l'Institut Catholique de Lille
🇫🇷Lille, France
CH de Seclin
🇫🇷Seclin, France
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
CH de Sens
🇫🇷Sens, France
Clinique Sainte Anne
🇫🇷Strasbourg, France
Hospital Universitario La Zarzuela
🇪🇸Madrid, Spain
Clinique de l'Anjou
🇫🇷Angers, France
Clinique Saint Vincent
🇫🇷Besançon, France
Centre Hospitalier Dubois - Brive la Gaillarde
🇫🇷Brive-la-Gaillarde, France
Hôpital Edouard Herriot (HCL - Lyon)
🇫🇷Lyon, France
CHR Orléans
🇫🇷Orléans, France
CHU St Pierre - Bruxelles
🇧🇪Brussel, Belgium
Clinique Victor PAUCHET
🇫🇷Amiens, France
Hôpital Privé Arras les Bonnettes
🇫🇷Arras, France
Hôpital Huriez - CHU de Lille
🇫🇷Lille, France
Polyclinique Sainte Marguerite - Institut d'Urologie- Auxerre
🇫🇷Auxerre, France
Hôpital Privé de la Châtaigneraie - Beaumont
🇫🇷Beaumont, France
CHU de Nimes-Hôpital Carémeau
🇫🇷Nîmes, France
CH de Mont-de-Marsan
🇫🇷Mont-de-Marsan, France
Hôpital Saint-Louis - APHP
🇫🇷Paris, France
CH de Bourg en Bresse
🇫🇷Bourg-en-Bresse, France
CH de Dax
🇫🇷Dax, France
CHU Grenoble Alpes
🇫🇷La Tronche, France
Centre Clinical - Soyaux
🇫🇷Soyaux, France
Hôpital Privé Jean Mermoz - Lyon
🇫🇷Lyon, France
CHU Conception - Marseille
🇫🇷Marseille, France
GH Privé Ambroise Paré - Hartmann
🇫🇷Neuilly-sur-Seine, France
CH Perpignan
🇫🇷Perpignan, France
CHU de Rouen
🇫🇷Rouen, France
CH de Saintonge
🇫🇷Saintes, France
CH de Valenciennes
🇫🇷Valenciennes, France
Hôpital Nord de Marseille
🇫🇷Marseille, France
AP-HP - Groupe Hospitalier Pitié-Salpêtrière - APHP
🇫🇷Paris, France
CHU de Nantes
🇫🇷Nantes, France
Hôpital Bichat - APHP
🇫🇷Paris, France
Clinique Rhéna - Strasbourg
🇫🇷Strasbourg, France
Hôpital Foch
🇫🇷Suresnes, France
CHU Guadeloupe
🇫🇷Pointe À Pitre, France
CHU Réunion (site Nord)
🇫🇷Saint-Denis, France
Hôpital Tenon - APHP
🇫🇷Paris, France
CHU de Rennes
🇫🇷Rennes, France
Centre Hospitalier Intercommunal Toulon-La Seyne sur mer
🇫🇷Toulon, France
CHRU de Nancy
🇫🇷Vandœuvre-lès-Nancy, France
CHU Toulouse - Hôpital Rangueil
🇫🇷Toulouse, France