Clinical trial NCT03618693: Impact of Perioperative Analgesia in Prostatectomy Patients on Early Quality of Recovery (SPITALIDO)
Official title: The Impact of Perioperative Analgesia in Prostatectomy Patients on Early Quality of Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatectomy
Pain
Keywords: prostatectomy
pain
recovery
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 142
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel group, single centre, interventional, active controlled trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of Recovery
timeFrame: From preoperative to postoperative day (POD) 1 i.e. within 24 hours after initiation of intervention
Secondary outcomes:
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: during the first 48 hours postoperatively
measure: Pain Score
timeFrame: within 6 hours postoperatively, on POD 1 and 2
measure: Gastrointestinal Function
timeFrame: During length of stay, expected to be on average 5 to 7 days
measure: Opioid Consumption
timeFrame: Within the first 48 hours postoperatively
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern
state: BE
Study officials:
affiliation: University Hospital Berne
name: Patrick Wüthrich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beilstein CM, Huber M, Furrer MA, Loffel LM, Wuethrich PY, Engel D. Impact of analgesic techniques on early quality of recovery after prostatectomy: A 3-arm, randomized trial. Eur J Pain. 2022 Oct;26(9):1990-2002. doi: 10.1002/ejp.2020. Epub 2022 Aug 21.