NCT06349668RecruitingPhase 3
Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
SMILe: Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 24 Mar 2024
- Start date
- Apr 2024
- Primary completion date
- Oct 2027
- Lead sponsor
- Hans Bahlmann
- Diseases
- Kidney cancer
- NCT number
- NCT06349668
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 220
- From Apr 2024 to the primary completion date, Oct 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient is scheduled for emergency surgery
- Scheduled significant simultaneous surgery on another organ
- 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 previously participated in the trial
Other illness
- 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
Lab values
- 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)
Other
- The patient has a ASA-class of IV or above
- 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
- Research staff not available
- The anesthesiologist in charge has planned spinal or epidural analgesia
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Länssjukhuset i Kalmar Coordinator of this site? Confirm its status | Kalmar | Sweden | Recruiting |
| University Hospital Linköping Coordinator of this site? Confirm its status | Linköping | Sweden | Recruiting |
| Centrallasarettet Växjö Coordinator of this site? Confirm its status | Vaxjo | Sweden | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.