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

Phase 3RecruitingNCT06349668

Hans Bahlmann220 enrolled

Overview

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.

Please refer to CTIS

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: First day after surgery

Secondary Outcomes

QoR-15 score preoperatively

Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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 from end of surgery (removing of surgical drapes or finishing of endoscopy, whichever comes last) until leaving the OR, up to 4 hrs

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

Amount of remifentanil during anesthesia in patients given remifentanil expressed in mcg/kg/min as recorded on the anesthetic chart.

Time frame: 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.

Time frame: 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

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

Amount of opioids administered at the PACU/ICU/HDU expressed in mcg/kg morphine equivalents as recorded on the post-anesthetic chart.

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

PONV requiring treatment at 0-6 hours and 6-24 hours

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

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.

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

Length of stay in calendary days

Time frame: 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

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

Y/N, based on a telephone interview

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

Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours

Time frame: 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.

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

Cardiac output corrected for Body Surface Area expressed in L/min/m2

Time frame: Intraoperative

Intraoperative Stroke Volume Index

Stroke volume corrected for Body Surface Area expressed in mL/m2

Time frame: Intraoperative

Intraoperative Cardiac Power Index

Cardiac Power Output corrected för Body Surface Area, expressed in Watt/m2, with higher values implying better cardiac performance.

Time frame: Intraoperative

Intraoperative dPmx

Maximum increase in arterial pressure during a cardiac cycle, expressed in mmHg/second, with higher values implying better cardiac contractility.

Time frame: 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

Time frame: 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

Time frame: Intraoperative

Intraoperative dynamic arterial elastance

Determined as Pulse Pressure Variation divided by Stroke Volume Variation

Time frame: Intraoperative

Intraoperative Systemic Vascular Resistance Index

Intraoperative Systemic Vascular Resistance corrected for Body Surface Area

Time frame: Intraoperative

Intraoperative heart rate

Time frame: Intraoperative

Biochemical markers of inflammation

To be specified later during the study (samples are stored for later analysis)

Time frame: Day of surgery and first and third day after surgery.

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts