Skip to content

Pain Intensity After RObotic Assisted Urological Surgery

Pain Intensity After RObotic Assisted Urological Surgery: the PAIROU Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05575284
Acronym
PAIROU
Enrollment
968
Registered
2022-10-12
Start date
2022-12-01
Completion date
2023-07-07
Last updated
2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

PROCEDURERobot-assisted urological surgery

Patient with programmed robot-assisted urological surgery

Sponsors

Société Française d'Anesthésie et de Réanimation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain level on D1 of surgeryDay 1 after surgeryMeasurement 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

MeasureTime frameDescription
Highest pain score at rest and during exerciseIn the first 48 hoursHighest 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 vomitingIn the first 48 hoursPatient presenting or not nausea and vomiting in the first 48 hours
Time of the first ambulationTime of the first ambulation during hospitalizationTime from robotic assisted urological surgery to the first ambulation
Date and time of resumption of transitDate and time of resumption of transitnumber of days between robotic assisted urological surgery and resumption of transit
Pain intensity (NRS) at rest and during exerciseSecond day after surgeryPain 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.
Duration of surgeryDuration of surgeryDuration of surgery: time between the begining of the robotic assisted urological surgery and the end of surgery.
Operator experience for the robotic assisted urological surgeryOperator 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
ComplicationsPeriod is defined from the day of robotic assisted urological surgery until the end of hospitalisationComplications according to the Dindo and Clavien classification
Length of stayFrom the first day of hospitalization to the last day of hospitalizationLength of stay at hospital (number of days)
Consumption of morphineDuring the 48 hours after surgeryConsumption of morphine (or equivalent (see morphine equivalent table)) in mg 48 hours after surgery

Countries

Belgium, France, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026