NCT06349668 Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
| NCT ID | NCT06349668 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hans Bahlmann |
| Condition | Other Specified Disorders of Kidney and Ureter |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 220 participants in total. It began in 2024-04-09 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Martin Holmberg
PRINCIPAL INVESTIGATOR
University Hospital, Linkoeping
Frequently Asked Questions
Who can join the NCT06349668 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Other Specified Disorders of Kidney and Ureter. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06349668 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 220 participants.
Is NCT06349668 currently recruiting?
Yes, NCT06349668 is actively recruiting participants. Contact the research team at hans.bahlmann@regionostergotland.se for enrollment information.
Where is the NCT06349668 trial being conducted?
This trial is being conducted at Kalmar, Sweden, Linköping, Sweden, Vaxjo, Sweden.
Who is sponsoring the NCT06349668 clinical trial?
NCT06349668 is sponsored by Hans Bahlmann. The principal investigator is Martin Holmberg at University Hospital, Linkoeping. The trial plans to enroll 220 participants.
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