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

Renal Cancer Clinical Trial

— SMILe  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06349668
• Other study ID #: 2023-505941-21-00
• Status: Recruiting
• Phase: Phase 3
• Start date: April 9, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Linkoeping
• Contact: Hans Bahlmann, MD PhD
• Phone: +46739312281
• Email: hans.bahlmann[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Neoplasms
• Neoplasms
• Renal Cancer
• Ureter Cancer
• Ureteral Neoplasms

Intervention

Drug:
• spinal analgesia with morphine and bupivacaine
single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery
• lidocaine infusion
intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t (Ideal Body Weight)

Locations

Country	Name	City	State
Sweden	University Hospital Linköping	Linköping

Sponsors (2)

Lead Sponsor	Collaborator
Hans Bahlmann	Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	First day after surgery
Secondary	QoR-15 score preoperatively	Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.	Any time between inclusion and the night before surgery
Secondary	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.	Seventh day after surgery
Secondary	Pain (NRS) in rest and during motion 2hrs after arrival to the PACU	Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain.	2 hrs after arrival to the PACU
Secondary	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.	First, second and third day after surgery
Secondary	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.	Seventh day after surgery
Secondary	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.
Secondary	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
Secondary	Incidence of unplanned termination of the lidocaine infusion		Intraoperatively
Secondary	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.	Intraoperatively
Secondary	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.	Intraoperatively
Secondary	Length of stay at the PACU		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
Secondary	Amount of opioids administred at the PACU	Amount of opioids administered at the PACU expressed in mcg/kg morphine equivalents as recorded on the post-anesthetic chart.	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
Secondary	Percentage of patients with 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
Secondary	"Time out-of-bed" on POD 1-3		First, second and third day after surgery
Secondary	Amount of opioids administered during the first 24 hours at the ward	Amount of opioids expressed in mcg/kg morphine equivalents administered during the first 24 hours at the ward as recorded on the ward chart.	During the first 24 hours at the ward
Secondary	First POD passing gases		From first until seventh day after surgery
Secondary	First POD passing stool		From first until seventh day after surgery
Secondary	Incidence of pruritus		From first until seventh day after surgery
Secondary	Length of stay	Length of stay in calendary days	From first until thirtieth day after surgery
Secondary	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	From first until thirtieth day after surgery
Secondary	Postoperative complications untill POD 30		From first until thirtieth day after surgery
Secondary	Requirement for opioids after discharge	Y/N, based on a telephone interview	From first until seventh day after surgery
Secondary	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
Secondary	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.	Intraoperatively
Secondary	Time with low blood pressure during anesthesia		Intraoperatively
Secondary	Lowest MAP within 10 minutes after induction of anesthesia		Within 10 minutes after induction of anesthesia
Secondary	Highest MAP within 10 minutes of abdominal insufflation		Within 10 minutes of abdominal insufflation
Secondary	Fraction of patients needing norepinephrine before start of surgery		From anesthesia induction until start of surgery (first incision or start of endoscopy, whichever comes first)
Secondary	Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of surgery)		Intraoperatively (later than 15 minutes after start of surgery)
Secondary	Average infusion rate of norepinephrine, in patients receiving norepinephrine, before start of surgery		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
Secondary	Average infusion rate of norepinephrine, in patients receiving norepinephrine, after start of surgery		From start of surgery (first incision or start of endoscopy, whichever comes first) until end of anesthesia (extubation), up to 48 hrs
Secondary	Intraoperative Cardiac Index	Cardiac output corrected for Body Surface Area expressed in L/min/m2	Intraoperative
Secondary	Intraoperative Stroke Volume Index	Stroke volume corrected for Body Surface Area expressed in mL/m2	Intraoperative
Secondary	Intraoperative Cardiac Power Index	Cardiac Power Output corrected för Body Surface Area, expressed in Watt/m2, with higher values implying better cardiac performance.	Intraoperative
Secondary	Intraoperative dPmx	Maximum increase in arterial pressure during a cardiac cycle, expressed in mmHg/second, with higher values implying better cardiac contractility.	Intraoperative
Secondary	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	Intraoperative
Secondary	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	Intraoperative
Secondary	Intraoperative dynamic arterial elastance	Determined as Pulse Pressure Variation divided by Stroke Volume Variation	Intraoperative
Secondary	Intraoperative Systemic Vascular Resistance Index	Intraoperative Systemic Vascular Resistance corrected for Body Surface Area	Intraoperative
Secondary	Intraoperative heart rate		Intraoperative
Secondary	Biochemical markers of inflammation	To be specified later during the study (samples are stored for later analysis)	Day of surgery and first and third day after surgery.