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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daycare: STALL | Experimental | Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients. |
|
| Daycare: local only | Active Comparator | Local ropivacaine infiltration only. Daycare patients. |
|
| In-patient: STALL | Experimental | Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery. |
|
| In-patient: local only | Active Comparator | Local ropivacaine infiltration only. In-patient surgery. |
|
| Emergency: STALL | Experimental | Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single transversus abdominis laparoscopy-guided plane block | Procedure | please see arm/group descriptions |
|
| Measure | Description | Time Frame |
|---|---|---|
| cumulative opioid consumption during the stay at the recovery | all groups; mg, morphine equivalent | duration of stay at the recovery (estimated 1-4 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| maximum NRS score during the day of surgery, after discharge (daycare / outpatient) | NRS (Numerical Rating Scale): 0-10 | 30 min after surgery, every 60 min afterwards; 2 days |
| cumulative opioid consumption (emergency and inpatient surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| maximum NRS score during the stay at the recovery | 0-10 | until the patient is either discharged to ward or home (day surgery patients), est. 1-4 hours |
| average NRS score during the stay at the recovery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roman Kornõšev, MD | Contact | +358 504 279755 | roman.kornosev@hus.fi | |
| Alexey Schramko, MD, PhD, Doc | Contact | +358 504 270610 | alexey.schramko@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Henna Sammalkorpi, MD, PhD | Helsinki UCH | Study Director |
| Hanna Lampela, MD, PhD | Helsinki UCH | Study Director |
| Jukka Harju, MD, PhD, Doc |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jorvi hospital / HUS | Recruiting | Espoo | Uusimaa | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29943054 | Background | Siriwardana RC, Kumarage SK, Gunathilake BM, Thilakarathne SB, Wijesinghe JS. Local infiltration versus laparoscopic-guided transverse abdominis plane block in laparoscopic cholecystectomy: double-blinded randomized control trial. Surg Endosc. 2019 Jan;33(1):179-183. doi: 10.1007/s00464-018-6291-0. Epub 2018 Jun 25. | |
| 34480217 |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D002764 | Cholecystitis |
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
| D001661 | Biliary Tract Neoplasms |
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Patients are analyzed following the intention to treat in three subgroups:
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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.
| Emergency: local only | Active Comparator | Local ropivacaine infiltration only. Emergency patients. |
|
|
| local trocar site ropivacaine infiltration | Procedure | please see arm/group descriptions |
|
mg, morphine equivalent
| while admitted; est. 2 days |
0-10
| duration of stay at the recovery, est. 1-4 hours |
| NRS score in multiple time points | if awake | every hour until discharge and at discharge = "ready to go" / "ready for transfer" (during in-hospital care), est. 48 hours |
| procedure time | min | minutes; est. 60 - 180 minutes |
| time necessary in recovery room | min, (= "patient ready to be discharged" timestamp OR "patient ready for transfer") | minutes; est. 60 - 260 min |
| complications related to the use of local anesthetics | TAP + port site infiltration complications (as per trial plan) + other complications according to Clavien-Dindo classification | est. 0 - 7 days |
| patient general satisfaction with pain management | using questionnaires, multiple timepoints: recovery stay, hospital stay, discharge, feedback after 7 days | prespecified: about 4 hours, 2 days, 7 days, 30 days |
| time from surgery to discharge | min | est. 2 - 48 hours |
| number of patients contacting the hospital regarding inadequate pain management | n | after discharge and before day 30 |
| prevalence of postoperative nausea and vomiting (PONV) and difference in subgroups | n; % | est. 0 - 4 (8) hours |
| difference in NRS (if any) between patients received remifentanil or fentanyl intraoperatively | delta | 0 - 4 hours |
| difference in NRS (if any) between patients received propofol or sevoflurane maintenance. | delta | 0- 4 hours |
| pain-control failure & possible causes | APS (acute pain service) contact, admission of DS subgroup patient to the ward due to pain, failure to discharge | acute: 0 - 2 days; chronic: t+30 days |
| Helsinki UCH |
| Study Director |
| Bumblyte V, Rasilainen SK, Ehrlich A, Scheinin T, Kontinen VK, Sevon A, Vaaraniemi H, Schramko AA. Purely ropivacaine-based TEA vs single TAP block in pain management after elective laparoscopic colon surgery within an upgraded institutional ERAS program. Surg Endosc. 2022 May;36(5):3323-3331. doi: 10.1007/s00464-021-08647-z. Epub 2021 Sep 3. |
| 29980989 | Background | Ruiz-Tovar J, Garcia A, Ferrigni C, Gonzalez J, Levano-Linares C, Jimenez-Fuertes M, Llavero C, Duran M. Laparoscopic-Guided Transversus Abdominis Plane (TAP) Block as Part of Multimodal Analgesia in Laparoscopic Roux-en-Y Gastric Bypass Within an Enhanced Recovery After Surgery (ERAS) Program: a Prospective Randomized Clinical Trial. Obes Surg. 2018 Nov;28(11):3374-3379. doi: 10.1007/s11695-018-3376-8. |
| 26885872 | Background | Peng K, Ji FH, Liu HY, Wu SR. Ultrasound-Guided Transversus Abdominis Plane Block for Analgesia in Laparoscopic Cholecystectomy: A Systematic Review and Meta-Analysis. Med Princ Pract. 2016;25(3):237-46. doi: 10.1159/000444688. Epub 2016 Feb 16. |
| 28913472 | Background | Breazu CM, Ciobanu L, Hadade A, Bartos A, Mitre C, Mircea PA, Ionescu D. The efficacy of oblique subcostal transversus abdominis plane block in laparoscopic cholecystectomy - a prospective, placebo controlled study. Rom J Anaesth Intensive Care. 2016 Apr;23(1):12-18. doi: 10.21454/rjaic.7518.231.obq. |
| 24619479 | Background | Loizides S, Gurusamy KS, Nagendran M, Rossi M, Guerrini GP, Davidson BR. Wound infiltration with local anaesthetic agents for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 12;2014(3):CD007049. doi: 10.1002/14651858.CD007049.pub2. |
| 25899736 | Background | Elamin G, Waters PS, Hamid H, O'Keeffe HM, Waldron RM, Duggan M, Khan W, Barry MK, Khan IZ. Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial. J Am Coll Surg. 2015 Aug;221(2):335-44. doi: 10.1016/j.jamcollsurg.2015.03.030. Epub 2015 Mar 27. |
| 22869941 | Background | Tolchard S, Davies R, Martindale S. Efficacy of the subcostal transversus abdominis plane block in laparoscopic cholecystectomy: Comparison with conventional port-site infiltration. J Anaesthesiol Clin Pharmacol. 2012 Jul;28(3):339-43. doi: 10.4103/0970-9185.98331. |
| 22330261 | Background | Ortiz J, Suliburk JW, Wu K, Bailard NS, Mason C, Minard CG, Palvadi RR. Bilateral transversus abdominis plane block does not decrease postoperative pain after laparoscopic cholecystectomy when compared with local anesthetic infiltration of trocar insertion sites. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):188-92. doi: 10.1097/AAP.0b013e318244851b. |
| 27746552 | Background | Bava EP, Ramachandran R, Rewari V, Chandralekha, Bansal VK, Trikha A. Analgesic efficacy of ultrasound guided transversus abdominis plane block versus local anesthetic infiltration in adult patients undergoing single incision laparoscopic cholecystectomy: A randomized controlled trial. Anesth Essays Res. 2016 Sep-Dec;10(3):561-567. doi: 10.4103/0259-1162.186620. |
| 28472015 | Background | Ravichandran NT, Sistla SC, Kundra P, Ali SM, Dhanapal B, Galidevara I. Laparoscopic-assisted Tranversus Abdominis Plane (TAP) Block Versus Ultrasonography-guided Transversus Abdominis Plane Block in Postlaparoscopic Cholecystectomy Pain Relief: Randomized Controlled Trial. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):228-232. doi: 10.1097/SLE.0000000000000405. |
| 30342470 | Background | Peng W, Huang S, Zhou S, Yang N, Zuo M. Case report: life-threatening coronary artery spasm under transversus abdominis plane block in combination with general anesthesia. BMC Anesthesiol. 2018 Oct 20;18(1):148. doi: 10.1186/s12871-018-0616-3. |
| 29214081 | Background | Salaria ON, Kannan M, Kerner B, Goldman H. A Rare Complication of a TAP Block Performed after Caesarean Delivery. Case Rep Anesthesiol. 2017;2017:1072576. doi: 10.1155/2017/1072576. Epub 2017 Oct 29. |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |