Pain Intensity After RObotic Assisted Urological Surgery

NCT ID: NCT05575284

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

968 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-07-07

Brief Summary

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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

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Conditions

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Robot-assisted Urological Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Robot-assisted urological surgery

Patients with programmed robot-assisted urological surgery

Robot-assisted urological surgery

Intervention Type PROCEDURE

Patient with programmed robot-assisted urological surgery

Interventions

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Robot-assisted urological surgery

Patient with programmed robot-assisted urological surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société Française d'Anesthésie et de Réanimation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hélène BELOEIL, MD

Role: STUDY_CHAIR

Teaching Hospital of Rennes, France

Locations

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CHU St Pierre - Bruxelles

Brussels, , Belgium

Site Status

Clinique Victor PAUCHET

Amiens, , France

Site Status

Clinique de l'Anjou

Angers, , France

Site Status

Hôpital Privé Arras les Bonnettes

Arras, , France

Site Status

Polyclinique Sainte Marguerite - Institut d'Urologie- Auxerre

Auxerre, , France

Site Status

Hôpital Privé de la Châtaigneraie - Beaumont

Beaumont, , France

Site Status

Clinique Saint Vincent

Besançon, , France

Site Status

CH de Bourg en Bresse

Bourg-en-Bresse, , France

Site Status

Centre Hospitalier Dubois - Brive la Gaillarde

Brive-la-Gaillarde, , France

Site Status

CH de Dax

Dax, , France

Site Status

CHU Grenoble Alpes

La Tronche, , France

Site Status

Hopital Bicêtre - APHP

Le Kremlin-Bicêtre, , France

Site Status

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, , France

Site Status

Hôpital Huriez - CHU de Lille

Lille, , France

Site Status

Hôpital Edouard Herriot (HCL - Lyon)

Lyon, , France

Site Status

CH Saint Joseph Saint Luc

Lyon, , France

Site Status

Hôpital Privé Jean Mermoz - Lyon

Lyon, , France

Site Status

CHU Conception - Marseille

Marseille, , France

Site Status

Hôpital Nord de Marseille

Marseille, , France

Site Status

CH de Mont-de-Marsan

Mont-de-Marsan, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

GH Privé Ambroise Paré - Hartmann

Neuilly-sur-Seine, , France

Site Status

CHU de Nimes-Hôpital Carémeau

Nîmes, , France

Site Status

CHR Orléans

Orléans, , France

Site Status

Hôpital Saint-Louis - APHP

Paris, , France

Site Status

AP-HP - Groupe Hospitalier Pitié-Salpêtrière - APHP

Paris, , France

Site Status

Hôpital Bichat - APHP

Paris, , France

Site Status

Hôpital Tenon - APHP

Paris, , France

Site Status

CH Perpignan

Perpignan, , France

Site Status

CHU Guadeloupe

Pointe à Pitre, , France

Site Status

CHU de Rennes

Rennes, , France

Site Status

CHU de Rouen

Rouen, , France

Site Status

CHU Réunion (site Nord)

Saint-Denis, , France

Site Status

CH de Saintonge

Saintes, , France

Site Status

CH de Seclin

Seclin, , France

Site Status

CH de Sens

Sens, , France

Site Status

Centre Clinical - Soyaux

Soyaux, , France

Site Status

Clinique Rhéna - Strasbourg

Strasbourg, , France

Site Status

Clinique Sainte Anne

Strasbourg, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Centre Hospitalier Intercommunal Toulon-La Seyne sur mer

Toulon, , France

Site Status

CHU Toulouse - Hôpital Rangueil

Toulouse, , France

Site Status

CH de Valenciennes

Valenciennes, , France

Site Status

CHRU de Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Hospital Universitario La Zarzuela

Madrid, , Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Countries

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Belgium France Spain

References

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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.

Reference Type BACKGROUND
PMID: 16698416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30822542 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34147158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25864615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23392233 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40409579 (View on PubMed)

Other Identifiers

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PAIROU 2022-04

Identifier Type: -

Identifier Source: org_study_id

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