Pain Intensity After RObotic Assisted Urological Surgery (PAIROU)

Pain Intensity After RObotic Assisted Urological Surgery: the PAIROU Study

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.

Study Overview

• Status: Completed
• Conditions: Robot-assisted Urological Surgery
• Intervention / Treatment: Procedure: Robot-assisted urological surgery

• Study Type: Observational
• Enrollment (Actual): 968

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1000
    • CHU St Pierre - Bruxelles
• France
  • Amiens, France, 80090
    • Clinique Victor Pauchet
  • Angers, France, 49044
    • Clinique de l'Anjou
  • Arras, France, 62000
    • Hopital Privé Arras les Bonnettes
  • Auxerre, France, 89000
    • Polyclinique Sainte Marguerite - Institut d'Urologie- Auxerre
  • Beaumont, France, 63110
    • Hôpital Privé de la Châtaigneraie - Beaumont
  • Besançon, France, 25000
    • Clinique Saint Vincent
  • Bourg-en-Bresse, France, 01012
    • CH de Bourg en Bresse
  • Brive-la-Gaillarde, France, 19100
    • Centre Hospitalier Dubois - Brive la Gaillarde
  • Dax, France, 40100
    • CH de Dax
  • La Tronche, France, 38700
    • Chu Grenoble Alpes
  • Le Kremlin-Bicêtre, France, 94270
    • Hôpital Bicêtre - APHP
  • Lille, France, 59037
    • Hôpital Huriez - CHU de Lille
  • Lille, France, 54900
    • Groupement des Hôpitaux de l'Institut Catholique de Lille
  • Lyon, France, 69003
    • Hôpital Edouard Herriot (HCL - Lyon)
  • Lyon, France, 69007
    • CH Saint Joseph Saint Luc
  • Lyon, France, 69008
    • Hôpital Privé Jean Mermoz - Lyon
  • Marseille, France, 13015
    • Hôpital Nord de Marseille
  • Marseille, France, 13005
    • CHU Conception - Marseille
  • Mont-de-Marsan, France, 40024
    • CH de Mont-de-Marsan
  • Nantes, France, 44093
    • CHU de Nantes
  • Neuilly-sur-Seine, France, 92200
    • GH Privé Ambroise Paré - Hartmann
  • Nîmes, France, 30900
    • CHU de Nimes-Hôpital Carémeau
  • Orléans, France, 45067
    • CHR Orléans
  • Paris, France, 75010
    • Hôpital Saint-Louis - APHP
  • Paris, France, 75020
    • Hôpital Tenon - APHP
  • Paris, France, 75018
    • Hôpital Bichat - APHP
  • Paris, France, 75013
    • AP-HP - Groupe Hospitalier Pitié-Salpêtrière - APHP
  • Perpignan, France, 66000
    • CH Perpignan
  • Pointe À Pitre, France, 97159
    • CHU Guadeloupe
  • Rennes, France, 35033
    • CHU de Rennes
  • Rouen, France, 76000
    • CHU de Rouen
  • Saint-Denis, France, 97400
    • CHU Réunion (site Nord)
  • Saintes, France, 17100
    • CH de Saintonge
  • Seclin, France, 59113
    • CH de Seclin
  • Sens, France, 89100
    • CH de Sens
  • Soyaux, France, 16800
    • Centre Clinical - Soyaux
  • Strasbourg, France, 67000
    • Clinique Sainte Anne
  • Strasbourg, France, 67000
    • Clinique Rhena - Strasbourg
  • Suresnes, France, 92150
    • Hôpital Foch
  • Toulon, France, 83100
    • Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer
  • Toulouse, France, 31059
    • CHU Toulouse - Hôpital Rangueil
  • Valenciennes, France, 59300
    • Ch de Valenciennes
  • Vandœuvre-lès-Nancy, France, 54500
    • CHRU de Nancy
• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28025
    • Hospital Universitario La Zarzuela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with planned robot-assisted urological surgery.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Robot-assisted urological surgery; Patients with programmed robot-assisted urological surgery	Procedure: Robot-assisted urological surgery; Patient with programmed robot-assisted urological surgery

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

Collaborators and Investigators

• Sponsor: Société Française d'Anesthésie et de Réanimation
• Investigators: Study Chair: Hélène BELOEIL, MD, Teaching Hospital of Rennes, France

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): July 7, 2023

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pain
• Other Study ID Numbers: PAIROU 2022-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No