Comparing spinal morphine and intravenous lidocaine for pain management in robotic kidney surgery
SMILe: Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
This study is testing if using spinal morphine for pain relief helps people recover better after robotic kidney surgery compared to using intravenous lidocaine.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Linkoeping Academic / other |
| Locations | 3 sites (Kalmar and 2 other locations) |
| Trial ID | NCT06349668 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if adding spinal analgesia improves recovery outcomes for patients undergoing robotic-assisted laparoscopic upper urinary tract surgery. It will assess the effectiveness of spinal morphine and bupivacaine compared to intravenous lidocaine in reducing postoperative pain and enhancing overall recovery as measured by the Quality of Recovery 15 scale. The study will also evaluate the impact on surgical workflow and potential complications associated with spinal analgesia. Participants will be monitored for pain levels, opioid use, and length of hospital stay.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for elective robotic-assisted upper urinary tract surgery who can provide informed consent.
Not a fit: Patients with severe comorbidities, emergency surgery needs, or those unable to understand the study information will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery experiences and reduced pain for patients undergoing upper urinary tract surgeries.
How similar studies have performed: Previous studies have shown promising results with spinal analgesia in similar surgical contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kalmar and 2 other locations
- Länssjukhuset i Kalmar — Kalmar, Sweden (Recruiting)
- University Hospital Linköping — Linköping, Sweden (Recruiting)
- Centrallasarettet Växjö — Vaxjo, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Martin Holmberg — University Hospital, Linkoeping
- Study coordinator: Hans Bahlmann, MD PhD
- Email: hans.bahlmann@regionostergotland.se
- Phone: +46739312281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.