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

NCT ID: NCT06349668

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-09
• Study Completion Date: 2027-12-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

lidocaine infusion

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

Group Type: ACTIVE_COMPARATOR

lidocaine infusion

Intervention Type: 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)

spinal analgesia

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

Group Type: EXPERIMENTAL

spinal analgesia with morphine and bupivacaine

Intervention Type: DRUG

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

Interventions

spinal analgesia with morphine and bupivacaine

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

Intervention Type: DRUG

lidocaine infusion

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)

Intervention Type: DRUG

Other Intervention Names

morphine spinal; xylocaine iv

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)
• The patient has previously participated in the trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Hans Bahlmann

OTHER

Sponsor Role: lead

Responsible Party

Hans Bahlmann

Senior Consultant. Sponsor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Martin Holmberg

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Linkoeping

Locations

Länssjukhuset i Kalmar

Kalmar, , Sweden

Site Status: RECRUITING

University Hospital Linköping

Linköping, , Sweden

Site Status: RECRUITING

Centrallasarettet Växjö

Vaxjo, , Sweden

Site Status: NOT_YET_RECRUITING

Countries

Sweden

Central Contacts

Hans Bahlmann, MD PhD

Role: CONTACT

hans.bahlmann@regionostergotland.se

+46739312281

Martin Holmberg, MD

Role: CONTACT

martin.holmberg@regionostergotland.se

+46101033932

Facility Contacts

Torgny Persson, MD

Role: primary

torgny.persson@regionkalmar.se

+46-10-3583353

Anna Maria Stoor, RN

Role: backup

annamaria.stoor@regionkalmar.se

Martin Holmberg, MD

Role: primary

martin.holmberg@regionostergotland.se

+46101033932

Marianna Vizbor, MD

Role: primary

marianna.vizbor@kronoberg.se

+46 470 58 9182

Elin Alfson, RN

Role: backup

elin.alfson@kronoberg.se

Other Identifiers

2023-505941-21-00

Identifier Type: -

Identifier Source: org_study_id