A Phase 3 interventional study of spinal analgesia with morphine and bupivacaine and lidocaine infusion in Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter and Calculus of Kidney and Ureter, sponsored by Hans Bahlmann. Recruiting at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Hans Bahlmann · Phase 3, Interventional, and Treatment
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
324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.
This study's planned enrollment of 220 is above the median of 92 across 257 interventional studies indexed under Nephrolithiasis.
Browse Nephrolithiasis studies →This is the only study on the registry with Hans Bahlmann as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery
Drug: spinal analgesia with morphine and bupivacaine
intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t (Ideal Body Weight)
Drug: lidocaine infusion
single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery
Also known as: morphine spinal
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)
Also known as: xylocaine iv
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.
Time frame: First day after surgery
QoR-15 score preoperatively
Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.
Time frame: Any time between inclusion and the night before surgery
QoR-15 score at postoperative day 7
Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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 frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: During the first 24 hours at the PACU and on the ward
First POD passing gases
First POD passing gases
Time frame: From first until seventh day after surgery
First POD passing stool
First POD passing stool
Time frame: From first until seventh day after surgery
Incidence of pruritus
Incidence of pruritus
Time frame: From first until seventh day after surgery
Length of stay
Length of stay in calendary days
Time frame: 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
Time frame: From first until thirtieth day after surgery
Postoperative complications untill POD 30
Postoperative complications untill POD 30
Time frame: From first until thirtieth day after surgery
Requirement for opioids after discharge
Y/N, based on a telephone interview
Time frame: 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
Time frame: 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.
Time frame: Intraoperatively
Time with low blood pressure during anesthesia
Time with low blood pressure during anesthesia
Time frame: Intraoperatively
Lowest MAP within 10 minutes after induction of anesthesia
Lowest MAP within 10 minutes after induction of anesthesia
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Intraoperative
Intraoperative Stroke Volume Index
Stroke volume corrected for Body Surface Area expressed in mL/m2
Time frame: Intraoperative
Intraoperative Cardiac Power Index
Cardiac Power Output corrected för Body Surface Area, expressed in Watt/m2, with higher values implying better cardiac performance.
Time frame: Intraoperative
Intraoperative dPmx
Maximum increase in arterial pressure during a cardiac cycle, expressed in mmHg/second, with higher values implying better cardiac contractility.
Time frame: 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
Time frame: 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
Time frame: Intraoperative
Intraoperative dynamic arterial elastance
Determined as Pulse Pressure Variation divided by Stroke Volume Variation
Time frame: Intraoperative
Intraoperative Systemic Vascular Resistance Index
Intraoperative Systemic Vascular Resistance corrected for Body Surface Area
Time frame: Intraoperative
Intraoperative heart rate
Intraoperative heart rate
Time frame: Intraoperative
Biochemical markers of inflammation
To be specified later during the study (samples are stored for later analysis)
Time frame: Day of surgery and first and third day after surgery.
Plan to share: Yes — Data will be made available on reasonable request
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Within 2 months of publication of the data involved
Access criteria: reasonable request
Started Apr 2024 (actual). Primary completion is estimated for Oct 2027, 41 months after the start.
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