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

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

NCT ID: NCT06349668

Condition: 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

Conditions: Official terms:
Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Calculi
Lidocaine
Morphine
Bupivacaine

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: spinal analgesia with morphine and bupivacaine
Description: single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery
Arm group label: spinal analgesia

Intervention type: Drug
Intervention name: lidocaine infusion
Description: intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t (Ideal Body Weight)
Arm group label: lidocaine infusion

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.

Criteria for 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, 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital Linköping

Address:
City: Linköping
Country: Sweden

Status: Recruiting

Contact:
Last name: Martin Holmberg, MD

Phone: +46101033932
Email: martin.holmberg@regionostergotland.se

Start date: April 9, 2024

Completion date: December 1, 2026

Lead sponsor:
Agency: Hans Bahlmann
Agency class: Other

Collaborator:
Agency: Linkoeping University
Agency class: Other

Source: University Hospital, Linkoeping

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06349668