Benign Neoplasm of Ureter, Benign Renal Neoplasm, Calculus of Kidney and Ureter, Congenital Ureteric Anomaly, Other Specified Disorders of Kidney and Ureter, Renal Cancer, Ureter Cancer, Ureteric Reflux
Conditions
Brief 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 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
Interventions
DRUGspinal analgesia with morphine and bupivacaine
single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery
DRUGlidocaine infusion
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)
Sponsors
Hans Bahlmann
Linkoeping University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoR-15 score at postoperative day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QoR-15 score preoperatively | Any time between inclusion and the night before surgery | Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing. |
| QoR-15 score at postoperative day 7 | Seventh day after surgery | Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing. |
| Pain (NRS) in rest and during motion 2hrs after arrival to the PACU/ICU/HDU | 2 hrs after arrival to the PACU | Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain. |
| Pain (NRS) on POD 1-3 | First, second and third day after surgery | Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain. |
| Pain (NRS) in rest and during motion at POD 7 | Seventh day after surgery | Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain. |
| 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 | Intraoperatively | Incidence of unplanned termination of the lidocaine infusion |
| Amount of remifentanil in patients given remifentanil | Intraoperatively | Amount of remifentanil during anesthesia in patients given remifentanil expressed in mcg/kg/min as recorded on the anesthetic chart. |
| Amount of intraoperative opioids in patients not receiving remifentanil | Intraoperatively | Amount of intraoperative opioids in patients not receiving remifentanil expressed in mcg/kg/min morphine equivalents as recorded on the anesthetic chart. |
| Length of stay at the PACU/ICU/HDU | 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 | 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 |
| Amount of opioids administred at the PACU/ICU/HDU during the first 24 hrs after end of surgery | 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 | Amount of opioids administered at the PACU/ICU/HDU expressed in mcg/kg morphine equivalents as recorded on the post-anesthetic chart. |
| PONV requiring treatment at 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay | 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 out-of-bed" on POD 1-3 | First, second and third day after surgery | "Time out-of-bed" on POD 1-3 |
| Amount of opioids administered during the first 24 hours at the PACU/ICU/HD and on the ward | During the first 24 hours at the PACU 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. |
| First POD passing gases | From first until seventh day after surgery | First POD passing gases |
| First POD passing stool | From first until seventh day after surgery | First POD passing stool |
| Incidence of pruritus | From first until seventh day after surgery | Incidence of pruritus |
| Length of stay | From first until thirtieth day after surgery | Length of stay in calendary days |
| DAOH30 | From first until thirtieth day after surgery | 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 |
| Postoperative complications untill POD 30 | From first until thirtieth day after surgery | Postoperative complications untill POD 30 |
| Requirement for opioids after discharge | From first until seventh day after surgery | Y/N, based on a telephone interview |
| Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours of induction of anesthesia | From induction of anesthesia until 48 hours after induction of anesthesia | Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours |
| Intraoperative fluid balance | Intraoperatively | 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 with low blood pressure during anesthesia | Intraoperatively | Time with low blood pressure during anesthesia |
| Lowest MAP within 10 minutes after induction of anesthesia | Within 10 minutes after induction of anesthesia | Lowest MAP within 10 minutes after induction of anesthesia |
| Highest MAP within 10 minutes of start of abdominal insufflation | Within 10 minutes of abdominal insufflation | Highest MAP within 10 minutes of 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 within 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) | Fraction of patients needing norepinephrine 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 | 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, before 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 | Average infusion rate of norepinephrine, in patients receiving norepinephrine, after 15 minutes after start of abdominal insufflation |
| Intraoperative Cardiac Index | Intraoperative | Cardiac output corrected for Body Surface Area expressed in L/min/m2 |
| Intraoperative Stroke Volume Index | Intraoperative | Stroke volume corrected for Body Surface Area expressed in mL/m2 |
| Intraoperative Cardiac Power Index | Intraoperative | Cardiac Power Output corrected för Body Surface Area, expressed in Watt/m2, with higher values implying better cardiac performance. |
| Intraoperative dPmx | Intraoperative | Maximum increase in arterial pressure during a cardiac cycle, expressed in mmHg/second, with higher values implying better cardiac contractility. |
| Intraoperative Pulse Pressure Variation | Intraoperative | 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 Stroke Volume Variation | Intraoperative | 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 dynamic arterial elastance | Intraoperative | Determined as Pulse Pressure Variation divided by Stroke Volume Variation |
| Intraoperative Systemic Vascular Resistance Index | Intraoperative | Intraoperative Systemic Vascular Resistance corrected for Body Surface Area |
| Intraoperative heart rate | Intraoperative | Intraoperative heart rate |
| Biochemical markers of inflammation | Day of surgery and first and third day after surgery. | To be specified later during the study (samples are stored for later analysis) |
Countries
Sweden
Contacts
CONTACTHans Bahlmann, MD PhD
CONTACTMartin Holmberg, MD
PRINCIPAL_INVESTIGATORMartin Holmberg
University Hospital, Linkoeping
Outcome results
None listed