NCT06349668

Recruiting

Phase 3

SMILe: Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery

Hans Bahlmann3 sites in 1 country220 target enrollmentApril 9, 2024

ConditionsOther 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

Interventionsspinal analgesia with morphine and bupivacaine lidocaine infusion

Drugsspinal analgesia with morphine and bupivacaine lidocaine infusion

Overview

Phase: Phase 3
Intervention: spinal analgesia with morphine and bupivacaine
Conditions: Other Specified Disorders of Kidney and Ureter
Sponsor: Hans Bahlmann
Enrollment: 220
Locations: 3
Primary Endpoint: QoR-15 score at postoperative day 1
Status: Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 9, 2024

End Date

December 31, 2027

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hans Bahlmann

Responsible Party

Sponsor Investigator

Principal Investigator

Hans Bahlmann

Senior Consultant. Sponsor

University Hospital, Linkoeping

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, 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)

Arms & Interventions

spinal analgesia

single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery

Intervention: spinal analgesia with morphine and bupivacaine

lidocaine infusion

intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t (Ideal Body Weight)

Intervention: lidocaine infusion

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Pain (NRS) in rest and during motion at POD 7(Seventh day after surgery)
QoR-15 score preoperatively(Any time between inclusion and the night before surgery)
QoR-15 score at postoperative day 7(Seventh day after surgery)
Pain (NRS) on POD 1-3(First, second and third day after surgery)
Length of stay(From first until thirtieth day after surgery)
Requirement for opioids after discharge(From first until seventh day after surgery)
Intraoperative Cardiac Index(Intraoperative)
Intraoperative Pulse Pressure Variation(Intraoperative)
Amount of remifentanil in patients given remifentanil(Intraoperatively)
Amount of intraoperative opioids in patients not receiving remifentanil(Intraoperatively)
DAOH30(From first until thirtieth day after surgery)
Intraoperative dynamic arterial elastance(Intraoperative)
Intraoperative Cardiac Power Index(Intraoperative)
Intraoperative Systemic Vascular Resistance Index(Intraoperative)
Intraoperative fluid balance(Intraoperatively)
Intraoperative Stroke Volume Index(Intraoperative)
Intraoperative Stroke Volume Variation(Intraoperative)
Intraoperative dPmx(Intraoperative)
Biochemical markers of inflammation(Day of surgery and first and third 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 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)
Incidence of unplanned termination of the lidocaine infusion(Intraoperatively)
"Time out-of-bed" on POD 1-3(First, second and third day after surgery)
First POD passing gases(From first until seventh day after surgery)
First POD passing stool(From first until seventh day after surgery)
Incidence of pruritus(From first until seventh day after surgery)
Postoperative complications untill POD 30(From first until thirtieth day after surgery)
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)
Time with low blood pressure during anesthesia(Intraoperatively)
Lowest MAP within 10 minutes after induction of anesthesia(Within 10 minutes after induction of anesthesia)
Intraoperative heart rate(Intraoperative)
Pain (NRS) in rest and during motion 2hrs after arrival to the PACU/ICU/HDU(2 hrs after arrival to the PACU)
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)
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)
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)
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)
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(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)(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, 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)