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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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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:
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.
Please refer to CTIS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spinal analgesia | Experimental | single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery |
|
| lidocaine infusion | Active Comparator | intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t (Ideal Body Weight) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spinal analgesia with morphine and bupivacaine | Drug | single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| QoR-15 score at postoperative day 1 | Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing. The primary research hypothesis is that the reduction in QoR-15 from baseline before surgery to the first postoperative day (POD 1) is at least 8.0 points less in the morphine spinal group compared to the control group treated with intravenous lidocaine. | First day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| QoR-15 score preoperatively | Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing. | Any time between inclusion and the night before surgery |
| QoR-15 score at postoperative day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hans Bahlmann, MD PhD | Contact | +46739312281 | hans.bahlmann@regionostergotland.se | |
| Martin Holmberg, MD | Contact | +46101033932 | martin.holmberg@regionostergotland.se |
| Name | Affiliation | Role |
|---|---|---|
| Martin Holmberg | University Hospital, Linkoeping | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Länssjukhuset i Kalmar | Recruiting | Kalmar | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42091145 | Derived | Holmberg M, Chew M, Nilsson L, Skoglund P, Bahlmann H. 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. BMJ Open. 2026 May 6;16(5):e113402. doi: 10.1136/bmjopen-2025-113402. |
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Data will be made available on reasonable request
Within 2 months of publication of the data involved
reasonable request
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|
| lidocaine infusion | Drug | intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t after a bolus of 2 mg/kg (Ideal Body Weight if BMI > 22, otherwise ABW) |
|
|
Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.
| Seventh day after surgery |
| Pain (NRS) in rest and during motion 2hrs after arrival to the PACU/ICU/HDU | Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain. | 2 hrs after arrival to the PACU |
| Pain (NRS) on POD 1-3 | Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain. | First, second and third day after surgery |
| Pain (NRS) in rest and during motion at POD 7 | Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain. | Seventh day after surgery |
| Time from arrival in the OR to start of surgery | Time from entering the OR to first incision or start of endoscopy, whichever comes first, up to 4 hrs. | Time from entering the OR to first incision or start of endoscopy, whichever comes first, up to 4 hrs. |
| Time from end of surgery until leaving the OR | Time from end of surgery (removing of surgical drapes or finishing of endoscopy, whichever comes last) until leaving the OR, up to 4 hrs | Time from end of surgery (removing of surgical drapes or finishing of endoscopy, whichever comes last) until leaving the OR, up to 4 hrs |
| Incidence of unplanned termination of the lidocaine infusion | Incidence of unplanned termination of the lidocaine infusion | Intraoperatively |
| Amount of remifentanil in patients given remifentanil | Amount of remifentanil during anesthesia in patients given remifentanil expressed in mcg/kg/min as recorded on the anesthetic chart. | Intraoperatively |
| Amount of intraoperative opioids in patients not receiving remifentanil | Amount of intraoperative opioids in patients not receiving remifentanil expressed in mcg/kg/min morphine equivalents as recorded on the anesthetic chart. | Intraoperatively |
| Length of stay at the PACU/ICU/HDU | Length of stay at the PACU/ICU/HDU (from first to final recording of any vital sign by the electronic patient data management system), up to 30 days | Length of stay at the PACU (from first to final recording of any vital sign by the electronic patient data management system), up to 30 days |
| Amount of opioids administred at the PACU/ICU/HDU during the first 24 hrs after end of surgery | Amount of opioids administered at the PACU/ICU/HDU expressed in mcg/kg morphine equivalents as recorded on the post-anesthetic chart. | During stay at the PACU (from first to final recording of any vital sign by the electronic patient data management system), up to 30 days |
| PONV requiring treatment at 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay | PONV requiring treatment at 0-6 hours and 6-24 hours | At 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay |
| "Time out-of-bed" on POD 1-3 | "Time out-of-bed" on POD 1-3 | First, second and third day after surgery |
| Amount of opioids administered during the first 24 hours at the PACU/ICU/HD and on the ward | Amount of opioids expressed in mcg/kg morphine equivalents administered during the first 24 hours at the PACU/ICU/HD and on the ward as recorded on the ward chart. | During the first 24 hours at the PACU and on the ward |
| First POD passing gases | First POD passing gases | From first until seventh day after surgery |
| First POD passing stool | First POD passing stool | From first until seventh day after surgery |
| Incidence of pruritus | Incidence of pruritus | From first until seventh day after surgery |
| Length of stay | Length of stay in calendary days | From first until thirtieth day after surgery |
| DAOH30 | Days Alive and Out of Hospital defined as the number of full calendary days where the patient is not admitted to a hospital and not deceased | From first until thirtieth day after surgery |
| Postoperative complications untill POD 30 | Postoperative complications untill POD 30 | From first until thirtieth day after surgery |
| Requirement for opioids after discharge | Y/N, based on a telephone interview | From first until seventh day after surgery |
| Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours of induction of anesthesia | Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours | From induction of anesthesia until 48 hours after induction of anesthesia |
| Intraoperative fluid balance | Intraoperative fluid balance as recorded on the CRF in ml, defined by the estimated sum of administered fluids minus estimated bleeding, diuresis and other measurable losses. | Intraoperatively |
| Time with low blood pressure during anesthesia | Time with low blood pressure during anesthesia | Intraoperatively |
| Lowest MAP within 10 minutes after induction of anesthesia | Lowest MAP within 10 minutes after induction of anesthesia | Within 10 minutes after induction of anesthesia |
| Highest MAP within 10 minutes of start of abdominal insufflation | Highest MAP within 10 minutes of start of abdominal insufflation | Within 10 minutes of abdominal insufflation |
| Fraction of patients needing norepinephrine within 15 minutes after start of abdominal insufflation | Fraction of patients needing norepinephrine within 15 minutes after start of abdominal insufflation | From anesthesia induction until 15 minutes after start of abdominal insufflation |
| Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of abdominal insufflation) | Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of abdominal insufflation) | Intraoperatively (later than 15 minutes after start of abdominal insufflation) |
| Average infusion rate of norepinephrine, in patients receiving norepinephrine, before 15 minutes after start of abdominal insufflation | Average infusion rate of norepinephrine, in patients receiving norepinephrine, before 15 minutes after start of abdominal insufflation | From anesthesia induction until 15 minutes after start of abdominal insufflation until end of anesthesiaon, up to 48 hours |
| Average infusion rate of norepinephrine, in patients receiving norepinephrine, after 15 minutes after start of abdominal insufflation | Average infusion rate of norepinephrine, in patients receiving norepinephrine, after 15 minutes after start of abdominal insufflation | From 15 minutes after start of abdominal insufflation until end of anesthesia (extubation), up to 48 hrs |
| Intraoperative Cardiac Index | Cardiac output corrected for Body Surface Area expressed in L/min/m2 | Intraoperative |
| Intraoperative Stroke Volume Index | Stroke volume corrected for Body Surface Area expressed in mL/m2 | Intraoperative |
| Intraoperative Cardiac Power Index | Cardiac Power Output corrected för Body Surface Area, expressed in Watt/m2, with higher values implying better cardiac performance. | Intraoperative |
| Intraoperative dPmx | Maximum increase in arterial pressure during a cardiac cycle, expressed in mmHg/second, with higher values implying better cardiac contractility. | Intraoperative |
| Intraoperative Pulse Pressure Variation | Determined as the ratio of the difference between the maximal and minimal values of pulse pressure over the mean of these two values and expressed as a percentage | Intraoperative |
| Intraoperative Stroke Volume Variation | Determined as the ratio of the difference between the maximal and minimal values of stroke volume over the mean of these two values and expressed as a percentage | Intraoperative |
| Intraoperative dynamic arterial elastance | Determined as Pulse Pressure Variation divided by Stroke Volume Variation | Intraoperative |
| Intraoperative Systemic Vascular Resistance Index | Intraoperative Systemic Vascular Resistance corrected for Body Surface Area | Intraoperative |
| Intraoperative heart rate | Intraoperative heart rate | Intraoperative |
| Biochemical markers of inflammation | To be specified later during the study (samples are stored for later analysis) | Day of surgery and first and third day after surgery. |
| University Hospital Linköping | Recruiting | Linköping | Sweden |
|
| Centrallasarettet Växjö | Not yet recruiting | Vaxjo | Sweden |
|
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D014516 | Ureteral Neoplasms |
| D014718 | Vesico-Ureteral Reflux |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014515 | Ureteral Diseases |
| D001745 | Urinary Bladder Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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