SMILe: Spinal Morphine or Intravenous Lidocaine in robot-assisted upper urologic surgery

Phase 1

Recruiting

• Conditions: Renal or ureter malignancy; Renal or ureter benign tumor; Nephrolithiasis; Renal reflux; MedDRA version: 20.0Level: LLTClassification code: 10032676Term: Other specified disorders of kidney and ureter Class: 10038359; MedDRA version: 21.0Level: PTClassification code: 10004418Term: Benign neoplasm of ureter Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code: 10007014Term: Calculus of kidney and ureter Class: 10038359; MedDRA version: 20.0Level: LLTClassification code: 10046375Term: Ureter cancer Class: 10029104; MedDRA version: 21.1Level: LLTClassification code: 10046408Term: Ureteric reflux Class: 10038359; MedDRA version: 20.0Level: PTClassification code: 10061078Term: Congenital ureteric anomaly Class: 100000004850

• Registration Number: CTIS2023-505941-21-00
• Lead Sponsor: Region Oestergoetland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-17
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

The patient 1) is scheduled for elective robotic-assisted upper urinary tract surgery at one of the participating hospitals; 2) gives oral and written informed consent after having received oral and written information about the study

Exclusion Criteria

The patient has a ASA-class of IV or above; the patient is a minor or declared incompetent, has severe psychiatric disease or is expected not to be able to understand the study information due to severe restrictions in vision, hearing, cognition, reading- or Swedish language abilities; the patient is pregnant or lactating or a fertile female (i.e. age < 45 and not sterilised) not using adequate contraception or not recently having had a negative pregnancy test; emergency surgery; research staff not available; significant simultaneous surgery on another organ; the anesthesiologist in charge has planned spinal or epidural analgesia; the patient has clear contraindications to spinal analgesia, e.g. severe coagulopathy, severe aortic stenosis, previous back surgery with rods, or spinal analgesia can be expected to be technically challenging (severe obesity, severe scoliosis); the patient has contraindications to lidocaine infusion: proven allergy to local anesthetics, renal failure ( eGFR < 30), hepatic failure caused by acute hepatitis or cirrhosis (Child-Pugh B or higher), severe cardiac arrythmias or insufficiency (NYHA IIIb or higher); previous participation in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study whether the addition of spinal analgesia with bupivacaine and morphine in patients having robotic-assisted laparoscopic upper urinary tract surgery in general anesthesia improves recovery after surgery as quantified by the patient-centered outcome scale Quality of Recovery 15;Secondary Objective: To study whether the addition of spinal analgesia with bupivacaine and morphine in patients having robotic-assisted laparoscopic upper urinary tract surgery in general anesthesia is associated with less pain, more speedy mobilization, a shorter length of stay, and fewer complications. Also the effects on intraoperative hemodynamics and perioperative inflammatory markers will be analyzed.;Primary end point(s): QoR-15 score at postoperative day 1