NCT03618693

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostatectomy
• Pain

Interventions

Type	Name	Description
PROCEDURE	Spinal anesthesia	Injection of a single shot of local anesthetic bupivacaine 0.5% combined with 20 mcg fentanyl intrathecally.
DEVICE	TAP Block	TAP block with a single shot of 20ml ropivacaine 0.375% combined with 75 mcg clonidine bilaterally
OTHER	Standard	Concomitant systemic administration of lidocaine (as an adjuvant) to the standard general anaesthesia. Lidocaine will administered initially during induction with a bolus of 1.5 mg per kgBW, followed by an infusion of 1.5 mg per kgBW per hour for 24 hours.

Timeline

• Start date: 2018-08-13
• Primary completion: 2021-12-13
• Completion: 2021-12-13
• First posted: 2018-08-07
• Last updated: 2021-12-14

Locations

1 site across 1 country: Switzerland