SMILe: Spinal Morphine or Intravenous Lidocaine in robot-assisted upper urologic surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Oestergoetland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

9 Apr 2024 → ongoing

Decision date (initial)

2023-10-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Region Östergötland

External identifiers

EU CT number

2023-505941-21-00

ClinicalTrials.gov

NCT06349668

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To study whether the addition of spinal analgesia with bupivacaine and morphine in patients having robotic-assisted laparoscopic upper urinary tract surgery in general anesthesia improves recovery after surgery as quantified by the patient-centered outcome scale "Quality of Recovery 15"

Secondary objectives 1

1. To study whether the addition of spinal analgesia with bupivacaine and morphine in patients having robotic-assisted laparoscopic upper urinary tract surgery in general anesthesia is associated with less pain, more speedy mobilization, a shorter length of stay, and fewer complications. Also the effects on intraoperative hemodynamics and perioperative inflammatory markers will be analyzed.

Conditions and MedDRA coding

Renal or ureter malignancy; Renal or ureter benign tumor; Nephrolithiasis; Renal reflux

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. The patient 1) is scheduled for elective robotic-assisted upper urinary tract surgery at one of the participating hospitals; 2) gives oral and written informed consent after having received oral and written information about the study

Exclusion criteria 1

1. 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 pregnant or lactating or a fertile female (i.e. age < 45 and not sterilised) not using adequate contraception or not recently having had a negative pregnancy test; emergency surgery; research staff not available; 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 contraindications to lidocaine infusion: proven allergy to local anesthetics, myasthenia gravis, renal failure ( eGFR < 30), hepatic failure caused by acute hepatitis or cirrhosis (Child-Pugh B or higher), severe cardiac arrythmias or insufficiency (NYHA IIIb or higher); previous participation in the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. QoR-15 score at postoperative day 1

Secondary endpoints 37

1. QoR-15 score preoperatively
2. QoR-15 score at postoperative day 2
3. pain (NRS) in rest and during motion 2hrs after arrival to the PACU/ICU/HDU
4. pain (NRS) on POD 1-3
5. pain (NRS) in rest and during motion at POD 7
6. Time from arrival in the OR to start of surgery
7. Time from end of surgery until leaving the OR
8. Incidence of unplanned termination of the lidocaine infusion
9. Amount of remifentanil in patients given remifentanil
10. amount of intraoperative opiods in patients not receiving remifentantil
11. length of stay at the PACU/ICU/HDU
12. amount of opioids administered at the PACU/ICU/HDU during the first 24 hrs from the end of surgery
13. PONV requiring treatment at 0-6hrs and 6-24 hrs postoperatively as well as during the whole postoperative stay
14. "Time out-of-bed" on POD 1-3
15. Amount of opioids administered during the first 24 hrs after end of surgery at the PACU/ICU/HDU and ward
16. First POD passing gases
17. First POD passing stool
18. incidence of pruritus
19. Length of stay and DAOH30
20. Postoperative complications untill POD 30
21. Requirement for opioids after discharge
22. Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hrs of induction of anesthesia
23. Intraoperative fluid balance
24. Time with low blood pressure during anesthesia
25. Lowest MAP within 10 minutes after induction of anesthesia
26. Highest MAP within 10 minutes of start of abdominal insufflation
27. Fraction of patients needing norepinephrine before start of surgery 15 minutes after start of insufflation
28. Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of insufflation)
29. Average infusion rate of norepinephrine, in patients receiving norepinephrine, before 15 minutes after start of insufflation
30. Average infusion rate of norepinephrine, in patients receiving norepinephrine, after 15 minutes after start of insufflation
31. Intraoperative Cardiac Index
32. Intraoperative Stroke Volume Index
33. Intraoperative Cardiac Power Index and dPmx
34. Intraoperative Pulse Pressure Variation and Stroke Volume Variation
35. Intraoperative Systemic Vascular Resistance Index
36. Intraoperative heart rate
37. biochemical markers of inflammation

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Oestergoetland

Sponsor organisation

Region Oestergoetland

Address

Universitetssjukhuset 1

City

Linkoping

Postcode

581 85

Country

Sweden

Scientific contact point

Organisation

Region Oestergoetland

Contact name

Hans Bahlmann

Public contact point

Organisation

Region Oestergoetland

Contact name

Hans Bahlmann

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications