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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Prostatectomy; Pain

Treatments: Procedure: Spinal anesthesia; Other: Standard; Device: TAP Block

Study type: Interventional

Funder types: Other

Identifiers

NCT03618693

WUPD01-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 3 patient groups

spinal analgesia SSS

Experimental group

Description:

Patients will receive a spinal analgesia (group SSS) with a single shot of bupivacaine 0.5% combined with fentanyl intrathecally during induction of anaesthesia. The technique used is referred to daily practice. All patients included in the study will receive the same postoperative multimodal analgesia starting at the end of surgery with the following regimen: 30 mg ketorolac 3\* per day for 48 hours intravenously and 1 gr 4\* per day metamizol intravenously or per oral, depending of the return of bowel function as baseline analgesia during length of hospitalization. Additional rescue analgesia will be provided and consisted in boluses of 25 mcg fentanyl intravenously (first 24 hours) and thereafter 5-10 mg oxycodone tablets (per oral administration). Postoperative rehabilitation according to the investigators enhanced recovery program including early mobilization and drinking (clear drinks).

Treatment:

Procedure: Spinal anesthesia

TAP block

Experimental group

Description:

Patients will receive a TAP block with a single shot of ropivacaine 0.375% combined with clonidine bilaterally. The technique used is referred to daily practice. The blocks will be performed under ultrasound guidance. All patients included in the study will receive the same postoperative multimodal analgesia starting at the end of surgery with the following regimen: 30 mg ketorolac 3\* per day for 48 hours intravenously and 1 gr 4\* per day metamizol intravenously or per oral, depending of the return of bowel function as baseline analgesia during length of hospitalization. Additional rescue analgesia will be provided and consisted in boluses of 25 mcg fentanyl intravenously (first 24 hours) and thereafter 5-10 mg oxycodone tablets (per oral administration). Postoperative rehabilitation according to the investigators enhanced recovery program including early mobilization and drinking (clear drinks).

Treatment:

Device: TAP Block

Standard

Active Comparator group

Description:

Standard care for prostatectomy in the investigators institution consists in the concomitant systemic administration of lidocaine to 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. All patients included in the study will receive the same postoperative multimodal analgesia starting at the end of surgery with the following regimen: 30 mg ketorolac 3\* per day for 48 hours and 1 gr 4\* per day metamizol intravenously or per oral, depending of the return of bowel function as baseline analgesia during length of hospitalization. Additional rescue analgesia will be provided and consisted in boluses of 25 mcg fentanyl intravenously (first 24 hours) and thereafter 5-10 mg oxycodone tablets. Postoperative rehabilitation according to the investigators enhanced recovery program including early mobilization and drinking (clear drinks).

Treatment:

Other: Standard