STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

Gallbladder Cancer Clinical Trial

— STALL  

Official title:

Single Transversus Abdominis Laparoscopy-guided Plane Block Combined With Local Trocar Site Ropivacaine Infiltration (STALL) vs Sole Local Wound Infiltration in LCC (Laparoscopic CholeCystectomy) - Double-blinded Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123117
• Other study ID #: 7351
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: October 2027

Study information

• Verified date: January 2024
• Source: Helsinki University Central Hospital
• Contact: Roman Kornõšev, MD
• Phone: +358 504 279755
• Email: roman.kornosev[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: October 2027
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Gallbladder Cancer
• Gallbladder Neoplasms
• Gallstones

Intervention

Procedure:
• single transversus abdominis laparoscopy-guided plane block
please see arm/group descriptions
• local trocar site ropivacaine infiltration
please see arm/group descriptions

Locations

Country	Name	City	State
Finland	Jorvi hospital / HUS	Espoo	Karvasmäentie 8

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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;(3):CD007049. doi: 10.1002/14651858.CD007049.pub2. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	average NRS score during the stay at the recovery	0-10	duration of stay at the recovery, est. 1-4 hours
Other	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
Other	procedure time	min	minutes; est. 60 - 180 minutes
Other	time necessary in recovery room	min, (= "patient ready to be discharged" timestamp OR "patient ready for transfer")	minutes; est. 60 - 260 min
Other	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
Other	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
Other	time from surgery to discharge	min	est. 2 - 48 hours
Other	number of patients contacting the hospital regarding inadequate pain management	n	after discharge and before day 30
Other	prevalence of postoperative nausea and vomiting (PONV) and difference in subgroups	n; %	est. 0 - 4 (8) hours
Other	difference in NRS (if any) between patients received remifentanil or fentanyl intraoperatively	delta	0 - 4 hours
Other	difference in NRS (if any) between patients received propofol or sevoflurane maintenance.	delta	0- 4 hours
Other	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
Primary	cumulative opioid consumption during the stay at the recovery	all groups; mg, morphine equivalent	duration of stay at the recovery (estimated 1-4 hours)
Secondary	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
Secondary	cumulative opioid consumption (emergency and inpatient surgery)	mg, morphine equivalent	while admitted; est. 2 days