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

NCT06349668 | Recruiting Phase 3 DMC

• 1 other identifier: 2023-505941-21-00
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

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.

Conditions

Benign Neoplasm of Ureter; Calculus of Kidney and Ureter; Ureter Cancer; Ureteric Reflux; Congenital Ureteric Anomaly; Benign Renal Neoplasm; Renal Cancer; Other Specified Disorders of Kidney and Ureter

Outcome Measures

Primary Outcomes (1)

• 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.

  First day after surgery

Secondary Outcomes (41)

• 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) in rest and during motion 2hrs after arrival to the PACU/ICU/HDU

  2 hrs after arrival to the PACU

• Pain (NRS) on POD 1-3

  First, second and third day after surgery

• Pain (NRS) in rest and during motion at POD 7

  Seventh day after surgery

Study Arms (2)

spinal analgesia

EXPERIMENTAL

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

Drug: spinal analgesia with morphine and bupivacaine

lidocaine infusion

ACTIVE COMPARATOR

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

Drug: lidocaine infusion

Interventions

lidocaine infusion DRUG

intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t after a bolus of 2 mg/kg (Ideal Body Weight if BMI \> 22, otherwise ABW)

Also known as: xylocaine iv

lidocaine infusion

spinal analgesia with morphine and bupivacaine DRUG

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

Also known as: morphine spinal

spinal analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hans Bahlmann: lead
• Linkoeping University: collaborator

Study Sites (3)

Länssjukhuset i Kalmar

Kalmar, Sweden

RECRUITING

University Hospital Linköping

Linköping, Sweden

RECRUITING

Centrallasarettet Växjö

Vaxjo, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Nephrolithiasis; Ureteral Neoplasms; Vesico-Ureteral Reflux; Kidney Neoplasms

Interventions

Morphine; Bupivacaine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Ureteral Diseases; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Martin Holmberg

  University Hospital, Linkoeping

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans Bahlmann, MD PhD

CONTACT

+46739312281; hans.bahlmann@regionostergotland.se

Martin Holmberg, MD

CONTACT

+46101033932; martin.holmberg@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant. Sponsor

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 5, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Within 2 months of publication of the data involved
• Access Criteria: reasonable request

Locations

SE (3)