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

Pain Clinical Trial

— SPITALIDO  

Official title:

The Impact of Perioperative Analgesia in Prostatectomy Patients on Early Quality of Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618693
• Other study ID #: WUPD01-18
• Status: Completed
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: December 13, 2021

Study information

• Verified date: December 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain
• Prostatectomy

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern	Bern	BE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative Nausea and Vomiting (PONV)	Groups will be assessed for postoperative nausea/vomiting by verbal descriptive scale at 6, 24 and 48 hours respectively.; Verbal descriptive Scale; 0 No nausea; Mild nausea; Moderate nausea; Frequent vomiting; Severe vomiting	during the first 48 hours postoperatively
Secondary	Pain Score	Pain will be assessed with the use of pain scores (incisional pain, "deep" visceral pain and pain during coughing/mobilization) according to the validated numeric rating scale (NRS with a range of 0 (no pain) to 10 (maximal pain)).	within 6 hours postoperatively, on POD 1 and 2
Secondary	Gastrointestinal Function	Return of gastrointestinal function (first flatus, first defecation, tolerance to food) in days.	During length of stay, expected to be on average 5 to 7 days
Secondary	Opioid Consumption	Use/amount of opioids intraoperative and postoperatively (transformed in morphine equivalent per 24 hours)	Within the first 48 hours postoperatively