Clinical trial NCT05575284: Pain Intensity After RObotic Assisted Urological Surgery
Official title: Pain Intensity After RObotic Assisted Urological Surgery: the PAIROU Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Robot-assisted Urological Surgery
Lead sponsor: Société Française d'Anesthésie et de Réanimation
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 968
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with planned robot-assisted urological surgery.

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.


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

Primary outcomes:
measure: Pain level on D1 of surgery
timeFrame: Day 1 after surgery
Secondary outcomes:
measure: Pain intensity (NRS) at rest and during exercise
timeFrame: Second day after surgery
measure: Highest pain score at rest and during exercise
timeFrame: In the first 48 hours
measure: Presence of side effect: Nausea and vomiting
timeFrame: In the first 48 hours
measure: Time of the first ambulation
timeFrame: Time of the first ambulation during hospitalization
measure: Date and time of resumption of transit
timeFrame: Date and time of resumption of transit
measure: Consumption of morphine
timeFrame: During the 48 hours after surgery
measure: Duration of surgery
timeFrame: Duration of surgery
measure: Operator experience for the robotic assisted urological surgery
timeFrame: 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.
measure: Complications
timeFrame: Period is defined from the day of robotic assisted urological surgery until the end of hospitalisation
measure: Length of stay
timeFrame: From the first day of hospitalization to the last day of hospitalization
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: CHU St Pierre - Bruxelles
city: Amiens
country: France
facility: Clinique Victor PAUCHET
city: Angers
country: France
facility: Clinique de l'Anjou
city: Arras
country: France
facility: Hôpital Privé Arras les Bonnettes
city: Auxerre
country: France
facility: Polyclinique Sainte Marguerite - Institut d'Urologie- Auxerre
city: Beaumont
country: France
facility: Hôpital Privé de la Châtaigneraie - Beaumont
city: Besançon
country: France
facility: Clinique Saint Vincent
city: Bourg-en-Bresse
country: France
facility: CH de Bourg en Bresse
city: Brive-la-Gaillarde
country: France
facility: Centre Hospitalier Dubois - Brive la Gaillarde
city: Dax
country: France
facility: CH de Dax
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Le Kremlin-Bicêtre
country: France
facility: Hopital Bicêtre - APHP
city: Lille
country: France
facility: Groupement des Hôpitaux de l'Institut Catholique de Lille
city: Lille
country: France
facility: Hôpital Huriez - CHU de Lille
city: Lyon
country: France
facility: Hôpital Edouard Herriot (HCL - Lyon)
city: Lyon
country: France
facility: CH Saint Joseph Saint Luc
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz - Lyon
city: Marseille
country: France
facility: CHU Conception - Marseille
city: Marseille
country: France
facility: Hôpital Nord de Marseille
city: Mont-de-Marsan
country: France
facility: CH de Mont-de-Marsan
city: Nantes
country: France
facility: CHU de Nantes
city: Neuilly-sur-Seine
country: France
facility: GH Privé Ambroise Paré - Hartmann
city: Nîmes
country: France
facility: CHU de Nimes-Hôpital Carémeau
city: Orléans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: Hôpital Saint-Louis - APHP
city: Paris
country: France
facility: AP-HP - Groupe Hospitalier Pitié-Salpêtrière - APHP
city: Paris
country: France
facility: Hôpital Bichat - APHP
city: Paris
country: France
facility: Hôpital Tenon - APHP
city: Perpignan
country: France
facility: CH Perpignan
city: Pointe À Pitre
country: France
facility: CHU Guadeloupe
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Denis
country: France
facility: CHU Réunion (site Nord)
city: Saintes
country: France
facility: CH de Saintonge
city: Seclin
country: France
facility: CH de Seclin
city: Sens
country: France
facility: CH de Sens
city: Soyaux
country: France
facility: Centre Clinical - Soyaux
city: Strasbourg
country: France
facility: Clinique Rhéna - Strasbourg
city: Strasbourg
country: France
facility: Clinique Sainte Anne
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon-La Seyne sur mer
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Rangueil
city: Valenciennes
country: France
facility: CH de Valenciennes
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy
city: Madrid
country: Spain
facility: Hospital Universitario La Zarzuela
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: Teaching Hospital of Rennes, France
name: Hélène BELOEIL, MD
role: STUDY_CHAIR
References:
citation: Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
citation: Aubrun F, Nouette-Gaulain K, Fletcher D, Belbachir A, Beloeil H, Carles M, Cuvillon P, Dadure C, Lebuffe G, Marret E, Martinez V, Olivier M, Sabourdin N, Zetlaoui P. Revision of expert panel's guidelines on postoperative pain management. Anaesth Crit Care Pain Med. 2019 Aug;38(4):405-411. doi: 10.1016/j.accpm.2019.02.011. Epub 2019 Feb 26.
citation: Panzenbeck P, von Keudell A, Joshi GP, Xu CX, Vlassakov K, Schreiber KL, Rathmell JP, Lirk P. Procedure-specific acute pain trajectory after elective total hip arthroplasty: systematic review and data synthesis. Br J Anaesth. 2021 Jul;127(1):110-132. doi: 10.1016/j.bja.2021.02.036.
citation: Harel M, Herbst KW, Silvis R, Makari JH, Ferrer FA, Kim C. Objective pain assessment after ureteral reimplantation: comparison of open versus robotic approach. J Pediatr Urol. 2015 Apr;11(2):82.e1-8. doi: 10.1016/j.jpurol.2014.12.007. Epub 2015 Feb 26.
citation: Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.