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Pain Intensity After RObotic Assisted Urological Surgery

NCT05575284 — Completed, 968 participants, Société Française d'Anesthésie et de Réanimation
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Pain Intensity After RObotic Assisted Urological Surgery: the PAIROU Study

RegistryNCT05575284, acronym PAIROU
StatusCompleted
Study typeObservational
Enrollment968 (Actual)
SponsorSociété Française d'Anesthésie et de Réanimation (Other)
ConditionsRobot-assisted Urological Surgery
InterventionsRobot-assisted urological surgery (Procedure)
Datesstart 2022-12-01, primary completion 2023-07-07, completion 2023-07-07, first posted 2022-10-12, last updated 2023-07-21
Locations46 sites in Belgium, France, Spain

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Robot-assisted urological surgeryProcedure: Robot-assisted urological surgeryPatients with programmed robot-assisted urological surgery
  • Robot-assisted urological surgery (Procedure): Patient with programmed robot-assisted urological surgery

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.
  • 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.
  • Presence of side effect: Nausea and vomiting [In the first 48 hours]: Patient presenting or not nausea and vomiting in the first 48 hours
  • Time of the first ambulation [Time of the first ambulation during hospitalization]: Time from robotic assisted urological surgery to the first ambulation
  • 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
  • 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)

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (46)

FacilityCityCountryStatus
CHU St Pierre - BruxellesBrusselsBelgium
Clinique Victor PAUCHETAmiensFrance
Clinique de l'AnjouAngersFrance
Hôpital Privé Arras les BonnettesArrasFrance
Polyclinique Sainte Marguerite - Institut d'Urologie- AuxerreAuxerreFrance
Hôpital Privé de la Châtaigneraie - BeaumontBeaumontFrance
Clinique Saint VincentBesançonFrance
CH de Bourg en BresseBourg-en-BresseFrance
Centre Hospitalier Dubois - Brive la GaillardeBrive-la-GaillardeFrance
CH de DaxDaxFrance
CHU Grenoble AlpesLa TroncheFrance
Hopital Bicêtre - APHPLe Kremlin-BicêtreFrance
Groupement des Hôpitaux de l'Institut Catholique de LilleLilleFrance
Hôpital Huriez - CHU de LilleLilleFrance
Hôpital Edouard Herriot (HCL - Lyon)LyonFrance
CH Saint Joseph Saint LucLyonFrance
Hôpital Privé Jean Mermoz - LyonLyonFrance
CHU Conception - MarseilleMarseilleFrance
Hôpital Nord de MarseilleMarseilleFrance
CH de Mont-de-MarsanMont-de-MarsanFrance
CHU de NantesNantesFrance
GH Privé Ambroise Paré - HartmannNeuilly-sur-SeineFrance
CHU de Nimes-Hôpital CarémeauNîmesFrance
CHR OrléansOrléansFrance
Hôpital Saint-Louis - APHPParisFrance
AP-HP - Groupe Hospitalier Pitié-Salpêtrière - APHPParisFrance
Hôpital Bichat - APHPParisFrance
Hôpital Tenon - APHPParisFrance
CH PerpignanPerpignanFrance
CHU GuadeloupePointe à PitreFrance
CHU de RennesRennesFrance
CHU de RouenRouenFrance
CHU Réunion (site Nord)Saint-DenisFrance
CH de SaintongeSaintesFrance
CH de SeclinSeclinFrance
CH de SensSensFrance
Centre Clinical - SoyauxSoyauxFrance
Clinique Rhéna - StrasbourgStrasbourgFrance
Clinique Sainte AnneStrasbourgFrance
Hôpital FochSuresnesFrance
Centre Hospitalier Intercommunal Toulon-La Seyne sur merToulonFrance
CHU Toulouse - Hôpital RangueilToulouseFrance
CH de ValenciennesValenciennesFrance
CHRU de NancyVandœuvre-lès-NancyFrance
Hospital Universitario La ZarzuelaMadridSpain
Hospital Clínico San CarlosMadridSpain

+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. PMID 16698416
  • 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
  • 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
  • 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
  • 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
  • Results publication: 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

+Investigators

  • Hélène BELOEIL, MD, Study chair, Teaching Hospital of Rennes, France

My Notes