Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06349668

SMILe: 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

13 weeks

Total Duration

On this page

Sponsors

H

Hans Bahlmann

Lead Sponsor

L

Linkoeping University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating whether adding spinal analgesia improves recovery for patients undergoing robotic-assisted laparoscopic upper urinary tract surgery under general anesthesia. This study aims to compare the effects of spinal analgesia with morphine and bupivacaine to an intravenous lidocaine infusion during surgery. It evaluates recovery using the Quality of Recovery 15 (QoR-15) scale and examines pain, nausea, opioid use, time out-of-bed, length of hospital stay, and complications, along with monitoring potential side effects like hypotension and cardiac dysfunction. Participants are randomly assigned to receive either a single shot spinal analgesia before surgery with morphine and bupivacaine or an intravenous lidocaine infusion during surgery. The spinal analgesia involves a one-time injection before surgery, while the lidocaine is given continuously during the operation. A subgroup of patients will have advanced heart function measurements and blood samples taken before, during, and after surgery to analyze inflammation and cardiac issues. Throughout the study, recovery will be assessed through interviews using the QoR-15 scale before surgery, on the first day after surgery, and on the seventh day. Patients will also keep a diary recording pain levels at rest and during movement three times daily. Researchers will track many outcomes including pain, nausea, opioid use, time spent out of bed, length of stay, and complications up to 30 days after surgery. Safety monitoring includes heart and blood pressure measurements during surgery, and blood tests for inflammation and heart function after surgery.

CONDITIONS

Brief 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
  • Provided oral and written informed consent after receiving study information
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of surgery and immediate intraoperative period

Participants receive either a single shot spinal analgesia with morphine and bupivacaine before surgery or an intraoperative intravenous lidocaine infusion during robot-assisted upper urologic surgery.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 30 days after surgery

Participants are monitored for recovery including pain levels, opioid use, and complications for up to 30 days after surgery.

Multiple visits during the first 7 days and follow-up assessments up to 30 days

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

M

Martin Holmberg, MD

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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Published Research Related To This Trial

Rationale and design of the SMILe (Spinal Morphine or Intravenous Lidocaine) study: protocol for a multicentre randomised clinical trial in southern Sweden on whether spinal morphine improves postoperative recovery compared to intravenous lidocaine in patients undergoing robot-assisted upper urinary tract surgery.

Martin Holmberg, Michelle Chew, Lena Nilsson...

https://pubmed.ncbi.nlm.nih.gov/42091145