Other Specified Disorders of Kidney and UreterPhase 3SMILeNCT06349668
Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
A Phase 3 study testing spinal analgesia with morphine and bupivacaine and lidocaine infusion in people with Other Specified Disorders of Kidney and Ureter and Benign Neoplasm of Ureter, run by Hans Bahlmann at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter, Calculus of Kidney and Ureter
- What is being tested?
- spinal analgesia with morphine and bupivacaine and lidocaine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesSweden
- Study dates
- 9 Apr 2024to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Länssjukhuset i Kalmar
Kalmar
Torgny Persson, MD, +46-10-3583353, torgny.persson@regionkalmar.se
Anna Maria Stoor, RN, annamaria.stoor@regionkalmar.se
- Recruiting
University Hospital Linköping
Linköping
Martin Holmberg, MD, +46101033932, martin.holmberg@regionostergotland.se
- Not yet recruiting
Centrallasarettet Växjö
Vaxjo
Marianna Vizbor, MD, +46 470 58 9182, marianna.vizbor@kronoberg.se
Elin Alfson, RN, elin.alfson@kronoberg.se
About this study
Official title: SMILe: 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-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 complications?
- Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery?
- Does spinal analgesia result in an increased incidence of hypotension and cardiac dysfunction during surgery, as well as an increased incidence of pruritus after surgery?
Read more
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.
Read the detailed description
Please refer to CTIS
- Conditions
- Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter, Calculus of Kidney and Ureter, Ureter Cancer, Ureteric Reflux, Congenital Ureteric Anomaly
- Being tested
- spinal analgesia with morphine and bupivacaine, lidocaine infusion
- Medical subject headings
- Nephrolithiasis, Ureteral Neoplasms, Vesico-Ureteral Reflux, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal analgesia with morphine and bupivacaineDrug
Also called morphine spinal
single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery
lidocaine infusionDrug
Also called xylocaine iv
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)
| Study group | Role | What they receive |
|---|---|---|
| spinal analgesia | Experimental | single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery Receives: Drug: spinal analgesia with morphine and bupivacaine |
| lidocaine infusion | Active comparator | intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t (Ideal Body Weight) Receives: Drug: lidocaine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First day after surgery
Secondary outcomes (41)
QoR-15 score preoperatively
Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: During the first 24 hours at the PACU and on the ward
First POD passing gases
First POD passing gases
Measured: From first until seventh day after surgery
First POD passing stool
First POD passing stool
Measured: From first until seventh day after surgery
Incidence of pruritus
Incidence of pruritus
Measured: From first until seventh day after surgery
Length of stay
Length of stay in calendary days
Measured: 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
Measured: From first until thirtieth day after surgery
Postoperative complications untill POD 30
Postoperative complications untill POD 30
Measured: From first until thirtieth day after surgery
Requirement for opioids after discharge
Y/N, based on a telephone interview
Measured: 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
Measured: 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.
Measured: Intraoperatively
Time with low blood pressure during anesthesia
Time with low blood pressure during anesthesia
Measured: Intraoperatively
Lowest MAP within 10 minutes after induction of anesthesia
Lowest MAP within 10 minutes after induction of anesthesia
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Intraoperative
Intraoperative Stroke Volume Index
Stroke volume corrected for Body Surface Area expressed in mL/m2
Measured: Intraoperative
Intraoperative Cardiac Power Index
Cardiac Power Output corrected för Body Surface Area, expressed in Watt/m2, with higher values implying better cardiac performance.
Measured: Intraoperative
Intraoperative dPmx
Maximum increase in arterial pressure during a cardiac cycle, expressed in mmHg/second, with higher values implying better cardiac contractility.
Measured: 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
Measured: 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
Measured: Intraoperative
Intraoperative dynamic arterial elastance
Determined as Pulse Pressure Variation divided by Stroke Volume Variation
Measured: Intraoperative
Intraoperative Systemic Vascular Resistance Index
Intraoperative Systemic Vascular Resistance corrected for Body Surface Area
Measured: Intraoperative
Intraoperative heart rate
Intraoperative heart rate
Measured: Intraoperative
Biochemical markers of inflammation
To be specified later during the study (samples are stored for later analysis)
Measured: Day of surgery and first and third day after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start9 Apr 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Specified Disorders of Kidney and UreterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hans Bahlmann
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Sponsor-investigator, Hans Bahlmann, University Hospital, Linkoeping
- Investigators
- Martin Holmberg, Principal investigator, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349668
- Sponsor's protocol ID
- 2023-505941-21-00
- Other IDs
- 2023
- Acronym
- SMILe
- Status last verified
- Feb 2026
- First submitted
- 24 Mar 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available on reasonable request
Publications
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.
PubMed 42091145
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMILe: Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
- ClinicalTrials.gov ID
- NCT06349668
- Acronym / sponsor ID
- SMILe / 2023-505941-21-00
- Conditions
- Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter, Calculus of Kidney and Ureter, Ureter Cancer, Ureteric Reflux, Congenital Ureteric Anomaly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hans BahlmannUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 complications?
- Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery?
- Does spinal analgesia result in an increased incidence of hypotension and cardiac dysfunction during surgery, as well as an increased incidence of pruritus after surgery?
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.
Detailed description
Please refer to CTIS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal analgesia | Experimental | Drug: spinal analgesia with morphine and bupivacainesingle shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery |
| lidocaine infusion | Active comparator | Drug: lidocaine infusionintraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t (Ideal Body Weight) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal analgesia with morphine and bupivacaineAlso: morphine spinalsingle shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery | Drug | spinal analgesia |
| lidocaine infusionAlso: xylocaine ivintraoperative 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) | Drug | lidocaine infusion |
Primary outcome
QoR-15 score at postoperative day 1
Time frame: First day after surgery
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.
41 secondary outcomes
QoR-15 score preoperatively
Time frame: Any time between inclusion and the night before surgery
QoR-15 score at postoperative day 7
Time frame: Seventh day after surgery
Pain (NRS) in rest and during motion 2hrs after arrival to the PACU/ICU/HDU
Time frame: 2 hrs after arrival to the PACU
Pain (NRS) on POD 1-3
Time frame: First, second and third day after surgery
Pain (NRS) in rest and during motion at POD 7
Time frame: Seventh day after surgery
Time from arrival in the OR to start of surgery
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 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
Time frame: Intraoperatively
Amount of remifentanil in patients given remifentanil
Time frame: Intraoperatively
Amount of intraoperative opioids in patients not receiving remifentanil
Time frame: Intraoperatively
Length of stay at the PACU/ICU/HDU
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
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
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 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
Time frame: During the first 24 hours at the PACU and on the ward
First POD passing gases
Time frame: From first until seventh day after surgery
First POD passing stool
Time frame: From first until seventh day after surgery
Incidence of pruritus
Time frame: From first until seventh day after surgery
Length of stay
Time frame: From first until thirtieth day after surgery
DAOH30
Time frame: From first until thirtieth day after surgery
Postoperative complications untill POD 30
Time frame: From first until thirtieth day after surgery
Requirement for opioids after discharge
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
Time frame: From induction of anesthesia until 48 hours after induction of anesthesia
Intraoperative fluid balance
Time frame: Intraoperatively
Time with low blood pressure during anesthesia
Time frame: Intraoperatively
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
Time frame: Within 10 minutes 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)
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
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
Time frame: From 15 minutes after start of abdominal insufflation until end of anesthesia (extubation), up to 48 hrs
Intraoperative Cardiac Index
Time frame: Intraoperative
Intraoperative Stroke Volume Index
Time frame: Intraoperative
Intraoperative Cardiac Power Index
Time frame: Intraoperative
Intraoperative dPmx
Time frame: Intraoperative
Intraoperative Pulse Pressure Variation
Time frame: Intraoperative
Intraoperative Stroke Volume Variation
Time frame: Intraoperative
Intraoperative dynamic arterial elastance
Time frame: Intraoperative
Intraoperative Systemic Vascular Resistance Index
Time frame: Intraoperative
Intraoperative heart rate
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 42091145Holmberg 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.
- Individual participant dataSharing planned: Yes. Data will be made available on reasonable request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Holmberg principal investigator
University Hospital, Linkoeping
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing spinal analgesia with morphine and bupivacaine and lidocaine infusion in people with Other Specified Disorders of Kidney and Ureter and Benign Neoplasm of Ureter, run by Hans Bahlmann at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hans Bahlmann, MD PhD (+46739312281, hans.bahlmann@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR-15 score at postoperative day 1 (time frame: First day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06349668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.