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

NCT03618693 | Completed

• 1 other identifier: WUPD01-18
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatectomy; Pain

Keywords

prostatectomy; pain; recovery

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery

  Changes in Quality of Recovery using the validated 15 items quality of recovery (QoR-15) score : QoR is a patient reported outcome short questionnaire that measure the quality of recovery after surgery and anaesthesia. It incorporates 5 dimensions of health (patient support, comfort, emotions, physical independence, pain). This is a shortened validated version of the QoR 40 including 15 items. QoR-15, with a score range from 0 to 150, is easy to perform. Recently a meta-analysis showed that QoR 15 fulfils requirements for outcome measurement instruments.

  From preoperative to postoperative day (POD) 1 i.e. within 24 hours after initiation of intervention

Secondary Outcomes (4)

• Postoperative Nausea and Vomiting (PONV)

  during the first 48 hours postoperatively

• Pain Score

  within 6 hours postoperatively, on POD 1 and 2

• Gastrointestinal Function

  During length of stay, expected to be on average 5 to 7 days

• Opioid Consumption

  Within the first 48 hours postoperatively

Study Arms (3)

spinal analgesia SSS

EXPERIMENTAL

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).

Procedure: Spinal anesthesia

TAP block

EXPERIMENTAL

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).

Device: TAP Block

Standard

ACTIVE COMPARATOR

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).

Other: Standard

Interventions

Spinal anesthesia PROCEDURE

Injection of a single shot of local anesthetic bupivacaine 0.5% combined with 20 mcg fentanyl intrathecally.

spinal analgesia SSS

TAP Block DEVICE

TAP block with a single shot of 20ml ropivacaine 0.375% combined with 75 mcg clonidine bilaterally

TAP block

Standard OTHER

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.

Also known as: Control Intervention

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35960649 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Patrick Wüthrich, MD

  University Hospital Berne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel group, single centre, interventional, active controlled trial

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: August 7, 2018
• Study Start: August 13, 2018
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)