Clinical trial NCT06349668: Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
Official title: Effekten av Intratekalt Morfin Eller intravenöst Lidokain på Postoperativ återhämtning Efter Robotassisterad övre Urologisk Kirurgi. Randomiserad Assessor-blindad Multicenterstudie. SMILe: Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: 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 Cancer
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2024-04-05
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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, 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

Primary outcomes:
measure: QoR-15 score at postoperative day 1
timeFrame: First day after surgery
Secondary outcomes:
measure: QoR-15 score preoperatively
timeFrame: Any time between inclusion and the night before surgery
measure: QoR-15 score at postoperative day 7
timeFrame: Seventh day after surgery
measure: Pain (NRS) in rest and during motion 2hrs after arrival to the PACU
timeFrame: 2 hrs after arrival to the PACU
measure: Pain (NRS) on POD 1-3
timeFrame: First, second and third day after surgery
measure: Pain (NRS) in rest and during motion at POD 7
timeFrame: Seventh day after surgery
measure: Time from arrival in the OR to start of surgery
timeFrame: Time from entering the OR to first incision or start of endoscopy, whichever comes first, up to 4 hrs.
measure: Time from end of surgery until leaving the OR
timeFrame: Time from end of surgery (removing of surgical drapes or finishing of endoscopy, whichever comes last) until leaving the OR, up to 4 hrs
measure: Incidence of unplanned termination of the lidocaine infusion
timeFrame: Intraoperatively
measure: Amount of remifentanil in patients given remifentanil
timeFrame: Intraoperatively
measure: Amount of intraoperative opioids in patients not receiving remifentanil
timeFrame: Intraoperatively
measure: Length of stay at the PACU
timeFrame: 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
measure: Amount of opioids administred at the PACU
timeFrame: 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
measure: Percentage of patients with PONV requiring treatment at 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay
timeFrame: At 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay
measure: "Time out-of-bed" on POD 1-3
timeFrame: First, second and third day after surgery
measure: Amount of opioids administered during the first 24 hours at the ward
timeFrame: During the first 24 hours at the ward
measure: First POD passing gases
timeFrame: From first until seventh day after surgery
measure: First POD passing stool
timeFrame: From first until seventh day after surgery
measure: Incidence of pruritus
timeFrame: From first until seventh day after surgery
measure: Length of stay
timeFrame: From first until thirtieth day after surgery
measure: DAOH30
timeFrame: From first until thirtieth day after surgery
measure: Postoperative complications untill POD 30
timeFrame: From first until thirtieth day after surgery
measure: Requirement for opioids after discharge
timeFrame: From first until seventh day after surgery
measure: Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours of induction of anesthesia
timeFrame: From induction of anesthesia until 48 hours after induction of anesthesia
measure: Intraoperative fluid balance
timeFrame: Intraoperatively
measure: Time with low blood pressure during anesthesia
timeFrame: Intraoperatively
measure: Lowest MAP within 10 minutes after induction of anesthesia
timeFrame: Within 10 minutes after induction of anesthesia
measure: Highest MAP within 10 minutes of abdominal insufflation
timeFrame: Within 10 minutes of abdominal insufflation
measure: Fraction of patients needing norepinephrine before start of surgery
timeFrame: From anesthesia induction until start of surgery (first incision or start of endoscopy, whichever comes first)
measure: Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of surgery)
timeFrame: Intraoperatively (later than 15 minutes after start of surgery)
measure: Average infusion rate of norepinephrine, in patients receiving norepinephrine, before start of surgery
timeFrame: From anesthesia induction until start of surgery (first incision or start of endoscopy, whichever comes first) until end of anesthesia (extubation), up to 48 hours
measure: Average infusion rate of norepinephrine, in patients receiving norepinephrine, after start of surgery
timeFrame: From start of surgery (first incision or start of endoscopy, whichever comes first) until end of anesthesia (extubation), up to 48 hrs
measure: Intraoperative Cardiac Index
timeFrame: Intraoperative
measure: Intraoperative Stroke Volume Index
timeFrame: Intraoperative
measure: Intraoperative Cardiac Power Index
timeFrame: Intraoperative
measure: Intraoperative dPmx
timeFrame: Intraoperative
measure: Intraoperative Pulse Pressure Variation
timeFrame: Intraoperative
measure: Intraoperative Stroke Volume Variation
timeFrame: Intraoperative
measure: Intraoperative dynamic arterial elastance
timeFrame: Intraoperative
measure: Intraoperative Systemic Vascular Resistance Index
timeFrame: Intraoperative
measure: Intraoperative heart rate
timeFrame: Intraoperative
measure: Biochemical markers of inflammation
timeFrame: Day of surgery and first and third day after surgery.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University Hospital Linköping
Study officials:
References: