Pain Intensity After RObotic Assisted Urological Surgery

NCT05575284 | Completed

• 1 other identifier: PAIROU 2022-04
• Study Type: observational
• Target: 968
• Locations: 3 countries
• Sites: 46

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.

Conditions

Robot-assisted Urological Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Pain intensity (NRS) at rest and during exercise

  Second day after surgery

• Highest pain score at rest and during exercise

  In the first 48 hours

• Presence of side effect: Nausea and vomiting

  In the first 48 hours

• Time of the first ambulation

  Time of the first ambulation during hospitalization

• Date and time of resumption of transit

  Date and time of resumption of transit

Study Arms (1)

Robot-assisted urological surgery

Patients with programmed robot-assisted urological surgery

Procedure: Robot-assisted urological surgery

Interventions

Robot-assisted urological surgery PROCEDURE

Patient with programmed robot-assisted urological surgery

Robot-assisted urological surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with planned robot-assisted urological surgery.

You may qualify if:

• Age \> or = 18 years old
• Programmed robot-assisted urological surgery
• Patient who did not declare any opposition to participating in the study

You may not qualify if:

• Urgent surgery
• Impossibility of communicating in French
• Cognitive deficit
• Adults legally protected or deprived of liberty

Sponsors & Collaborators

• Société Française d'Anesthésie et de Réanimation: lead

Study Sites (46)

CHU St Pierre - Bruxelles

Brussels, 1000, Belgium

Location

Clinique Victor PAUCHET

Amiens, 80090, France

Location

Clinique de l'Anjou

Angers, 49044, France

Location

Hôpital Privé Arras les Bonnettes

Arras, 62000, France

Location

Polyclinique Sainte Marguerite - Institut d'Urologie- Auxerre

Auxerre, 89000, France

Location

Hôpital Privé de la Châtaigneraie - Beaumont

Beaumont, 63110, France

Location

Clinique Saint Vincent

Besançon, 25000, France

Location

CH de Bourg en Bresse

Bourg-en-Bresse, 01012, France

Location

Centre Hospitalier Dubois - Brive la Gaillarde

Brive-la-Gaillarde, 19100, France

Location

CH de Dax

Dax, 40100, France

Location

CHU Grenoble Alpes

La Tronche, 38700, France

Location

Hopital Bicêtre - APHP

Le Kremlin-Bicêtre, 94270, France

Location

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, 54900, France

Location

Hôpital Huriez - CHU de Lille

Lille, 59037, France

Location

Hôpital Edouard Herriot (HCL - Lyon)

Lyon, 69003, France

Location

CH Saint Joseph Saint Luc

Lyon, 69007, France

Location

Hôpital Privé Jean Mermoz - Lyon

Lyon, 69008, France

Location

CHU Conception - Marseille

Marseille, 13005, France

Location

Hôpital Nord de Marseille

Marseille, 13015, France

Location

CH de Mont-de-Marsan

Mont-de-Marsan, 40024, France

Location

CHU de Nantes

Nantes, 44093, France

Location

GH Privé Ambroise Paré - Hartmann

Neuilly-sur-Seine, 92200, France

Location

CHU de Nimes-Hôpital Carémeau

Nîmes, 30900, France

Location

CHR Orléans

Orléans, 45067, France

Location

Hôpital Saint-Louis - APHP

Paris, 75010, France

Location

AP-HP - Groupe Hospitalier Pitié-Salpêtrière - APHP

Paris, 75013, France

Location

Hôpital Bichat - APHP

Paris, 75018, France

Location

Hôpital Tenon - APHP

Paris, 75020, France

Location

CH Perpignan

Perpignan, 66000, France

Location

CHU Guadeloupe

Pointe à Pitre, 97159, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CHU de Rouen

Rouen, 76000, France

Location

CHU Réunion (site Nord)

Saint-Denis, 97400, France

Location

CH de Saintonge

Saintes, 17100, France

Location

CH de Seclin

Seclin, 59113, France

Location

CH de Sens

Sens, 89100, France

Location

Centre Clinical - Soyaux

Soyaux, 16800, France

Location

Clinique Rhéna - Strasbourg

Strasbourg, 67000, France

Location

Clinique Sainte Anne

Strasbourg, 67000, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Centre Hospitalier Intercommunal Toulon-La Seyne sur mer

Toulon, 83100, France

Location

CHU Toulouse - Hôpital Rangueil

Toulouse, 31059, France

Location

CH de Valenciennes

Valenciennes, 59300, France

Location

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Hospital Universitario La Zarzuela

Madrid, 28025, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Related Publications (6)

• 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.

  PMID: 16698416 BACKGROUND

• 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.

  PMID: 30822542 BACKGROUND

• 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.

  PMID: 34147158 BACKGROUND

• 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.

  PMID: 25864615 BACKGROUND

• 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.

  PMID: 23392233 BACKGROUND

• Rouxel P, Rayon E, Bellocq AS, le Guen M, Fessler J, Cirenei C, Blondonnet R, Parfait E, Patrubani AG, Ramorasata A, Gouel A, Brogly N, Devoldere G, Dupont M, Gaultier E, Dupuis M, Bouzat P, Cattenoz M, Prieur S, Cuvillon P, Gricourt Y, Pastene B, Huette P, Garot M, Ramarosaona A, Massin R, Grailles G, Rolle A, Daouda IM, Boinette R, Birckener J, Habrial P, Samaha T, Lemoine A, Damon A, Rodriguez M, Braun T, Fritsch M, Tawil S, Guerin V, Lagrave-Blampied L, Ravry C, Poette M, Tao-Mauny S, Mfam WS, Fontaine M, Boutouria M, Deffar N, Sigwalt F, Thiltges L, Ionescu M, Diaz-Pache MVA, Perez RN, Caragliano G, Profumo L, Peyronnet B, Renault A, Joosten A, Beloeil H; PAIROU group and French Society of Anesthesiologists (SFAR) Research Network. Pain intensity after robotic-assisted urological surgery: the PAIROU study an international prospective cohort study. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101546. doi: 10.1016/j.accpm.2025.101546. Epub 2025 May 21.

  PMID: 40409579 DERIVED

Study Officials

• Hélène BELOEIL, MD

  Teaching Hospital of Rennes, France

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 12, 2022
• Study Start: December 1, 2022
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

FR (43); ES (2); BE (1)