PAIROU: Pain Intensity After RObotic Assisted Urological Surgery

Sponsor
Société Française d'Anesthésie et de Réanimation (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05575284
Collaborator
(none)
400
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Robot-assisted urological surgery

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pain Intensity After RObotic Assisted Urological Surgery: the PAIROU Study
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Robot-assisted urological surgery

Patients with programmed robot-assisted urological surgery

Procedure: Robot-assisted urological surgery
Patient with programmed robot-assisted urological surgery

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. 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.

  3. Presence of side effect: Nausea and vomiting [In the first 48 hours]

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

  4. Time of the first ambulation [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 [Date and time of resumption of transit]

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

  6. Consumption of morphine [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 [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 [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 [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 [From the first day of hospitalization to the last day of hospitalization]

    Length of stay at hospital (number of days)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Société Française d'Anesthésie et de Réanimation

Investigators

  • Study Chair: Hélène BELOEIL, MD, Teaching Hospital of Rennes, France

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Société Française d'Anesthésie et de Réanimation
ClinicalTrials.gov Identifier:
NCT05575284
Other Study ID Numbers:
  • PAIROU 2022-04
First Posted:
Oct 12, 2022
Last Update Posted:
Oct 12, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2022