Impact of Perioperative Analgesia in Prostatectomy Patients on Early Quality of Recovery (SPITALIDO)

The Impact of Perioperative Analgesia in Prostatectomy Patients on Early Quality of Recovery

The rationale behind this RCT is to assess within 24 hours after surgery the quality of recovery of prostatectomy patients treated with 3 different analgesia concepts (intraoperative spinal analgesia, transversus abdominis plane block, intravenous lidocaine administration) using the quality of recovery (QoR) 15 questionnaire.

Prostatectomy (open or robotic assisted) is a major urological surgery, which is associated with relevant acute postoperative pain. Perioperative analgesic techniques aiming at optimizing postoperative analgesia have to be investigated. Optimal postoperative pain management is one of the key factors leading to enhanced recovery after surgery. Optimal analgesia should aim for optimized patient comfort, fast functional recovery with the fewest side effects thus encouraging the DREAMS concept (DRinking, EAting, Mobilizing and Sleeping).

The perioperative additional use of a spinal single shot analgesia, or a transversus abdominis plane block to general anaesthesia are validated options to enhance pain therapy compared to systemic analgesia alone. However, if the impact on pain scores has been described previously, the impact on the quality of recovery (QoR) is still unclear. Using the assessment of QoR allows for a much more objective and broader assessment of the quality of the postoperative treatment. Indeed, patient's perioperative experience cannot be only focused on pain scores but should involve items like physical independence, patient support, comfort, emotion. All these items are included in already validated QoR questionnaires like the QoR 15 or QoR 40.

The rationale behind this randomized, parallel group, single centre, interventional, active controlled trial is to assess with the QoR 15questionnaire within 24 hours after surgery the quality of recovery of prostatectomy patients treated with 3 different analgesia concepts.

Inclusion Criteria:

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• >18 years old
• eGFR >40ml/min
• Normal liver function
• Prostatectomy (open, robotic assisted)

Exclusion Criteria:

• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
• Patients with regular use of antiemetics, laxatives, opioids or other types of analgesics
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Previous enrolment into the current study,
• Enrolment of the investigator, his/her family members, employees and other dependent persons,
• Severe psychiatric disorder
• Patients with chronic pain
• Preoperative regular use of non-steroidal anti-inflammatory drugs
• Refusal of regional analgesia (SSS or TAP block)
• Contraindication to regional analgesia (SSS or TAP block)