Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT06349668
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D014516', 'term': 'Ureteral Neoplasms'}, {'id': 'D014718', 'term': 'Vesico-Ureteral Reflux'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014515', 'term': 'Ureteral Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2024-03-24', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QoR-15 score at postoperative day 1', 'timeFrame': 'First day after surgery', 'description': 'Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.'}], 'secondaryOutcomes': [{'measure': 'QoR-15 score preoperatively', 'timeFrame': 'Any time between inclusion and the night before surgery', 'description': 'Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.'}, {'measure': 'QoR-15 score at postoperative day 7', 'timeFrame': 'Seventh day after surgery', 'description': 'Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.'}, {'measure': 'Pain (NRS) in rest and during motion 2hrs after arrival to the PACU', 'timeFrame': '2 hrs after arrival to the PACU', 'description': 'Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain.'}, {'measure': 'Pain (NRS) on POD 1-3', 'timeFrame': 'First, second and third day after surgery', 'description': 'Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain.'}, {'measure': 'Pain (NRS) in rest and during motion at POD 7', 'timeFrame': 'Seventh day after surgery', 'description': 'Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain.'}, {'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', 'description': 'Amount of remifentanil during anesthesia in patients given remifentanil expressed in mcg/kg/min as recorded on the anesthetic chart.'}, {'measure': 'Amount of intraoperative opioids in patients not receiving remifentanil', 'timeFrame': 'Intraoperatively', 'description': 'Amount of intraoperative opioids in patients not receiving remifentanil expressed in mcg/kg/min morphine equivalents as recorded on the anesthetic chart.'}, {'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', 'description': 'Amount of opioids administered at the PACU expressed in mcg/kg morphine equivalents as recorded on the post-anesthetic chart.'}, {'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', 'description': 'Amount of opioids expressed in mcg/kg morphine equivalents administered during the first 24 hours at the ward as recorded on the ward chart.'}, {'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', 'description': 'Length of stay in calendary days'}, {'measure': 'DAOH30', 'timeFrame': 'From first until thirtieth day after surgery', 'description': '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'}, {'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', 'description': 'Y/N, based on a telephone interview'}, {'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', 'description': '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.'}, {'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', 'description': 'Cardiac output corrected for Body Surface Area expressed in L/min/m2'}, {'measure': 'Intraoperative Stroke Volume Index', 'timeFrame': 'Intraoperative', 'description': 'Stroke volume corrected for Body Surface Area expressed in mL/m2'}, {'measure': 'Intraoperative Cardiac Power Index', 'timeFrame': 'Intraoperative', 'description': 'Cardiac Power Output corrected för Body Surface Area, expressed in Watt/m2, with higher values implying better cardiac performance.'}, {'measure': 'Intraoperative dPmx', 'timeFrame': 'Intraoperative', 'description': 'Maximum increase in arterial pressure during a cardiac cycle, expressed in mmHg/second, with higher values implying better cardiac contractility.'}, {'measure': 'Intraoperative Pulse Pressure Variation', 'timeFrame': 'Intraoperative', 'description': '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'}, {'measure': 'Intraoperative Stroke Volume Variation', 'timeFrame': 'Intraoperative', 'description': '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'}, {'measure': 'Intraoperative dynamic arterial elastance', 'timeFrame': 'Intraoperative', 'description': 'Determined as Pulse Pressure Variation divided by Stroke Volume Variation'}, {'measure': 'Intraoperative Systemic Vascular Resistance Index', 'timeFrame': 'Intraoperative', 'description': 'Intraoperative Systemic Vascular Resistance corrected for Body Surface Area'}, {'measure': 'Intraoperative heart rate', 'timeFrame': 'Intraoperative'}, {'measure': 'Biochemical markers of inflammation', 'timeFrame': 'Day of surgery and first and third day after surgery.', 'description': 'To be specified later during the study (samples are stored for later analysis)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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']}, 'descriptionModule': {'briefSummary': '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:\n\n* 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?\n* 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?\n* Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery?\n* 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?\n\nParticipants will be randomized to receive either spinal analgesia with bupivacaine and morphine preoperatively or an intravenous infusion with lidocaine intraoperatively.\n\nQoR-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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is scheduled for elective robotic-assisted upper urinary tract surgery at one of the participating hospitals\n* The patient gives oral and written informed consent after having received oral and writen information about the study\n\nExclusion Criteria:\n\n* The patient has a ASA-class of IV or above\n* 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\n* The patient is a female who is pregnant or breastfeeding\n* 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\n* The patient is scheduled for emergency surgery\n* Research staff not available\n* Scheduled significant simultaneous surgery on another organ\n* The anesthesiologist in charge has planned spinal or epidural analgesia\n* 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)\n* 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)\n* The patient has previously participated in the trial'}, 'identificationModule': {'nctId': 'NCT06349668', 'acronym': 'SMILe', 'briefTitle': 'Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2023-505941-21-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'spinal analgesia', 'description': 'single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery', 'interventionNames': ['Drug: spinal analgesia with morphine and bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lidocaine infusion', 'description': 'intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t (Ideal Body Weight)', 'interventionNames': ['Drug: lidocaine infusion']}], 'interventions': [{'name': 'spinal analgesia with morphine and bupivacaine', 'type': 'DRUG', 'description': 'single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery', 'armGroupLabels': ['spinal analgesia']}, {'name': 'lidocaine infusion', 'type': 'DRUG', 'description': 'intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t (Ideal Body Weight)', 'armGroupLabels': ['lidocaine infusion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Martin Holmberg, MD', 'role': 'CONTACT', 'email': 'martin.holmberg@regionostergotland.se', 'phone': '+46101033932'}], 'facility': 'University Hospital Linköping', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'centralContacts': [{'name': 'Hans Bahlmann, MD PhD', 'role': 'CONTACT', 'email': 'hans.bahlmann@regionostergotland.se', 'phone': '+46739312281'}, {'name': 'Martin Holmberg, MD', 'role': 'CONTACT', 'email': 'martin.holmberg@regionostergotland.se', 'phone': '+46101033932'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Within 2 months of publication of the data involved', 'ipdSharing': 'YES', 'description': 'Data will be made available on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hans Bahlmann', 'class': 'OTHER'}, 'collaborators': [{'name': 'Linkoeping University', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant. Sponsor', 'investigatorFullName': 'Hans Bahlmann', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}