Cholecystitis, Cholelithiasis, Gallbladder Cancer
Conditions
Keywords
laparoscopic transversus abdominis plane block
Brief summary
This trial is a prospective randomized superiority trial comparing sole ropivacaine based local trocar site infiltration to local infiltration combined with laparoscopic ropivacaine TAP block (STALL) in LCC. There are only a few randomized trials comparing sole local anesthesia to additional laparoscopic TAP block in laparoscopic cholecystectomy and they have yet failed to show evidence in favor of TAP block. We hypothesize STALL (Single Transversus Abdominis Laparoscopy-guided plane block combined with Local trocar site ropivacaine infiltration) is superior to local port site infiltration, provided that the sample size is sufficiently big. The aim of this randomized study is to compare the efficacy of sole local anesthesia of trocar sites to STALL in LCC.
Interventions
PROCEDUREsingle transversus abdominis laparoscopy-guided plane block
please see arm/group descriptions
PROCEDURElocal trocar site ropivacaine infiltration
please see arm/group descriptions
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study will be blinded to patients and recovery room personnel, as well as the ward nurses and physicians, but not to operating surgeon(s), anesthesiologist(s), and nurses, treating patients during the surgery.
Intervention model description
Patients are analyzed following the intention to treat in three subgroups: 1. Patients treated in day-care outpatient surgical unit (DS): TAP+local vs local. 2. Patients treated electively in the inpatient surgery unit (IS): TAP+local vs local. 3. Emergency surgery patients (ES): TAP+local vs local.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients scheduled for elective or emergency LCC, aged over 18 and able to give an informed consent.
Exclusion criteria
* Age under 18 years, chronic daily opioid and/or pain tolerance / pain threshold -modifying medication use (abuse), pregnancy, known allergy to local anesthetics, diagnosed severe coagulopathy and incapability to give informed consent for whatever reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cumulative opioid consumption during the stay at the recovery | duration of stay at the recovery (estimated 1-4 hours) | all groups; mg, morphine equivalent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maximum NRS score during the day of surgery, after discharge (daycare / outpatient) | 30 min after surgery, every 60 min afterwards; 2 days | NRS (Numerical Rating Scale): 0-10 |
| cumulative opioid consumption (emergency and inpatient surgery) | while admitted; est. 2 days | mg, morphine equivalent |
Other
| Measure | Time frame | Description |
|---|---|---|
| procedure time | minutes; est. 60 - 180 minutes | min |
| time necessary in recovery room | minutes; est. 60 - 260 min | min, (= patient ready to be discharged timestamp OR patient ready for transfer) |
| number of patients contacting the hospital regarding inadequate pain management | after discharge and before day 30 | n |
| complications related to the use of local anesthetics | est. 0 - 7 days | TAP + port site infiltration complications (as per trial plan) + other complications according to Clavien-Dindo classification |
| prevalence of postoperative nausea and vomiting (PONV) and difference in subgroups | est. 0 - 4 (8) hours | n; % |
| time from surgery to discharge | est. 2 - 48 hours | min |
| maximum NRS score during the stay at the recovery | until the patient is either discharged to ward or home (day surgery patients), est. 1-4 hours | 0-10 |
| average NRS score during the stay at the recovery | duration of stay at the recovery, est. 1-4 hours | 0-10 |
| NRS score in multiple time points | every hour until discharge and at discharge = ready to go / ready for transfer (during in-hospital care), est. 48 hours | if awake |
| pain-control failure & possible causes | acute: 0 - 2 days; chronic: t+30 days | APS (acute pain service) contact, admission of DS subgroup patient to the ward due to pain, failure to discharge |
| patient general satisfaction with pain management | prespecified: about 4 hours, 2 days, 7 days, 30 days | using questionnaires, multiple timepoints: recovery stay, hospital stay, discharge, feedback after 7 days |
| difference in NRS (if any) between patients received remifentanil or fentanyl intraoperatively | 0 - 4 hours | delta |
| difference in NRS (if any) between patients received propofol or sevoflurane maintenance. | 0- 4 hours | delta |
Countries
Finland
Contacts
Primary ContactRoman Kornõšev, MD
Backup ContactAlexey Schramko, MD, PhD, Doc
Outcome results
None listed