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

NCT ID: NCT03618693

Last Updated: 2021-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-13
• Study Completion Date: 2021-12-13

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.

Conditions

Prostatectomy; Pain

Keywords

prostatectomy; pain; recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

spinal analgesia SSS

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).

Group Type: EXPERIMENTAL

Spinal anesthesia

Intervention Type: PROCEDURE

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

TAP block

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).

Group Type: EXPERIMENTAL

TAP Block

Intervention Type: DEVICE

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

Standard

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).

Group Type: ACTIVE_COMPARATOR

Standard

Intervention Type: 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.

Interventions

Spinal anesthesia

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

Intervention Type: PROCEDURE

TAP Block

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Control Intervention

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Wüthrich, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Berne

Locations

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

Bern, Canton of Bern, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 35960649 (View on PubMed)

Other Identifiers

WUPD01-18

Identifier Type: -

Identifier Source: org_study_id