Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery (SMILe)

Hans Bahlmann

Status and phase: Enrolling; Phase 3

Conditions: Congenital Ureteric Anomaly; Ureter Cancer; Renal Cancer; Benign Neoplasm of Ureter; Benign Renal Neoplasm; Calculus of Kidney and Ureter; Ureteric Reflux; Other Specified Disorders of Kidney and Ureter

Treatments: Drug: spinal analgesia with morphine and bupivacaine; Drug: lidocaine infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06349668

2023-505941-21-00

Details and patient eligibility

About

The goal of this clinical trial is to learn whether the addition of spinal analgesia leads to superior recovery in patients undergoing robotic-assisted laparoscopic upper urinary tract surgery under general anesthesia. The main questions it aims to answer are:

• Is the decrease in wellbeing as quantified by the patient-centered outcome scale "Quality of Recovery 15" (QoR-15), from baseline to the first day after surgery (POD 1), at least 8.0 points less in patients receiving spinal analgesia in addition to general anesthesia?
• Does spinal analgesia result in improved recovery as quantified by QoR-15 at POD 7, the incidence of postoperative pain at rest and at mobilization, nausea and vomiting, the need for opioid analgesics, time out-of-bed, length of stay and the incidence of complications?
• Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery?
• Does spinal analgesia result in an increased incidence of hypotension and cardiac dysfunction during surgery, as well as an increased incidence of pruritus after surgery?

Participants will be randomized to receive either spinal analgesia with bupivacaine and morphine preoperatively or an intravenous infusion with lidocaine intraoperatively.

QoR-15 and other markers of recovery will be registered using structured interviews preoperatively, at POD1 and POD7. In addition, patients will record pain at rest and at mobilization three times daily in a diary.

In a subgroup of patients advanced hemodynamic parameters will be recorded using pulse-contour analysis before, during and after surgery. Blood samples will also be collected in these patients at fixed intervals and analyzed for amongst others inflammation and cardiac dysfunction.

Full description

Please refer to CTIS

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient is scheduled for elective robotic-assisted upper urinary tract surgery at one of the participating hospitals
• The patient gives oral and written informed consent after having received oral and writen 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 a female who is pregnant or breastfeeding
• The patient is a pre-menopausal female who has not undergone sterilisation, hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy, and is not using highly-effective contraception with low user-dependency and cannot provide a negative pregnancy test
• The patient is scheduled for emergency surgery
• Research staff not available
• Scheduled 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 clear contraindications to lidocaine infusion, e.g. proven allergy to local anesthetics, myasthenia gravis, renail failure (eGFR < 30), hepatic failure caused by acute hepatitis or cirrhosis (Child-Pugh B or higher, severe cardiac arrythmias or insuffiency (NYHA IIIb or higher)
• The patient has previously participated in the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

spinal analgesia

Experimental group

Description:

single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery

Treatment:

Drug: spinal analgesia with morphine and bupivacaine

lidocaine infusion

Active Comparator group

Description:

intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t (Ideal Body Weight)

Treatment:

Drug: lidocaine infusion