Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
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
| Condition(s) | Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter, Calculus of Kidney and Ureter, Ureter Cancer, Ureteric Reflux, Congenital Ureteric Anomaly, Benign Renal Neoplasm, Renal Canc |
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| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 complicatio |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Hans Bahlmann |
| Locations | Kalmar, Sweden; Linköping, Sweden; Vaxjo, Sweden |
| Start date | 2024-04-09 |
| NCT ID | NCT06349668 |
| Official listing | https://clinicaltrials.gov/study/NCT06349668 |