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Completed

NCT Number: NCT05575284

Pain Intensity After RObotic Assisted Urological Surgery

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU St Pierre - Bruxelles, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-assisted urological surgery

Procedure

Patient with programmed robot-assisted urological surgery

Primary outcomes

  1. Pain level on D1 of surgery

    Time frame: 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

  1. Pain intensity (NRS) at rest and during exercise

    Time frame: 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.

  2. Highest pain score at rest and during exercise

    Time frame: 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.

  3. Presence of side effect: Nausea and vomiting

    Time frame: In the first 48 hours

    Patient presenting or not nausea and vomiting in the first 48 hours

  4. Time of the first ambulation

    Time frame: Time of the first ambulation during hospitalization

    Time from robotic assisted urological surgery to the first ambulation

  5. Date and time of resumption of transit

    Time frame: Date and time of resumption of transit

    number of days between robotic assisted urological surgery and resumption of transit

  6. Consumption of morphine

    Time frame: During the 48 hours after surgery

    Consumption of morphine (or equivalent (see morphine equivalent table)) in mg 48 hours after surgery

  7. Duration of surgery

    Time frame: Duration of surgery

    Duration of surgery: time between the begining of the robotic assisted urological surgery and the end of surgery.

  8. Operator experience for the robotic assisted urological surgery

    Time frame: 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

  9. Complications

    Time frame: Period is defined from the day of robotic assisted urological surgery until the end of hospitalisation

    Complications according to the Dindo and Clavien classification

  10. Length of stay

    Time frame: From the first day of hospitalization to the last day of hospitalization

    Length of stay at hospital (number of days)

Sponsors and collaborators

Lead sponsor

Société Française d'Anesthésie et de Réanimation

Other

Registry information

Official study title

Pain Intensity After RObotic Assisted Urological Surgery: the PAIROU Study

Acronym: PAIROU

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2022
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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