Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06349668

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

Led by Hans Bahlmann · Updated on 2026-02-05

220

Participants Needed

3

Research Sites

194 weeks

Total Duration

On this page

Sponsors

H

Hans Bahlmann

Lead Sponsor

L

Linkoeping University

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for elective robotic-assisted upper urinary tract surgery at a participating hospital
  • Able and willing to give oral and written informed consent after receiving study information
Not Eligible

You will not qualify if you...

  • ASA class IV or higher
  • Minor, declared incompetent, severe psychiatric disease, or severe restrictions in vision, hearing, cognition, reading, or Swedish language abilities
  • Female who is pregnant or breastfeeding
  • Pre-menopausal female without sterilization or hysterectomy and not using highly effective contraception or unable to provide a negative pregnancy test
  • Scheduled for emergency surgery
  • Research staff not available
  • Scheduled significant simultaneous surgery on another organ
  • Planned spinal or epidural analgesia by anesthesiologist
  • Contraindications to spinal analgesia such as severe coagulopathy, severe aortic stenosis, previous back surgery with rods, or expected technical difficulties (severe obesity, severe scoliosis)
  • Contraindications to lidocaine infusion such as allergy to local anesthetics, myasthenia gravis, renal failure (eGFR < 30), severe liver failure, severe cardiac arrhythmias or insufficiency (NYHA IIIb or higher)
  • Previous participation in this trial

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Länssjukhuset i Kalmar

Kalmar, Sweden

Actively Recruiting

2

University Hospital Linköping

Linköping, Sweden

Actively Recruiting

3

Centrallasarettet Växjö

Vaxjo, Sweden

Not Yet Recruiting

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Research Team

H

Hans Bahlmann, MD PhD

CONTACT

M

Martin Holmberg, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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