NCT05427266|UnknownDMC
Laparoscopic Transversus Abdominis Plane Block (LTAP) for Appendicectomy Versus Standard Port Site Treatment
TapBlock
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TapBlock
Sponsor study identifier
interventional
172
0 countries
N/A
Study Start
July 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study aims to compare Laparoscopic assisted LTAP (Transversus Abdominis Plane) to standard port-site infiltration in terms of post-operative visual analogue scores (VAS) for pain at 3, 6, 12 and 24 hours following laparoscopic appendicectomy Tap Block is a standard conventional analgesia protocol for laparoscopic appendicitis used in Beaumont Hospital, and other hospitals throughout Ireland. The medicinal product for both groups is the same - Bupivacaine. The mode of administration is what this study is reviewing: Control group (Standard port site infiltration) and Study Group - Laparoscopic Transversus Abdominis Plane Block
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 9, 2022
Actual (reported)June 22, 2022
Actual (reported)July 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Assessing pain post laparoscopic appendicectomy using Visual analogue score (VAS score)
Assessing any change in pain score from a scale of 1 to 10 (1 being the worst pain and 10 no pain) using VAS score template
Assessing change in pain score post extubation at 3 hours, 6 hours, 12 hours and 24 hours.
Post-operative Opioid requirement
Assess opioid requirement post operatively in the first 24 hours
Time to first mobilisation post-operatively
Assess time to mobility in the first 24 hours post operatively
Study Group: Study group: Laparoscopic Transversus Abdominis Plane in four points: above and below the umbilicus in both right and left sides; dose calculation 2.5mg per body weight. After the appendicectomy is done and just before withdrawing port and deflating the abdomen, the operating surgeon will advance a needle into the abdominal wall to the level of the preperitoneal space. Once the needle tip is seen, it is withdrawn slowly and gently about 0.5cm above/superficial to the transversus abdominis (TA) muscle. The surgeon then infiltrates the local anaesthetic into the plane, and the right plane is confirmed by visualising a uniform protrusion downwards of the TA muscle fibres (Doyle's bulge). Seeing a preperitoneal or muscle blister laparoscopically indicates that the infiltration is deeper to this plane, and the needle should be withdrawn more superficially.
Patients will be randomised after diagnosis either clinically or radiologically of appendicitis (both complicated and uncomplicated) Control Group \_ standard port site infiltration using 0.25% plain bupivacaine. The dose is calculated to 2.5mg/per kg body weight. After the appendicectomy is done, after removal of ports and deflating the abdomen, the total calculated dose volume will be infiltrated into the subcutaneous plane at the umbilicus and the other 2 ports sites
The medicinal product for both groups is the same - Bupivacaine. The mode of administration is what this study is reviewing: Control group (Standard port site infiltration) and Study Group - Laparoscopic Transversus Abdominis Plane Block (LTap Block)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Daly GR, Dowling GP, Hembrecht S, O'Grady S, Hegarty A, Roche T, Orsi G, Pierre A, Calpin GG, Neary C, Hehir CM, Hill GJ, O'Brien A, Duggan WP, Davey MG, Stephens IJB, Kennedy ND, Brennan O, Hayes C, Al Azzawi M, Balasubramanian I, McGuire A, Zaborowski AM, Reynolds IS, Loughlin P, Allen M, Power C, Butt A, Boland MR, McCawley N, Burke JP, Robb WB, Mastrosimone A, Arumugasamy M, Prins H, Beddy D, Kerin MJ, McNamara DA, Kearney D, Sorensen J, Curley GF, Abd El Wahab S, Hill ADK. Laparoscopic-assisted transversus abdominis plane block versus port-site infiltration in appendicectomy: multicentre randomized clinical trial. Br J Surg. 2025 Dec 24;113(1):znaf257. doi: 10.1093/bjs/znaf257.
Arnold Hill
Royal College of Surgeons in Ireland
First Submitted
June 9, 2022
First Posted
June 22, 2022
Study Start
July 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Role of Ultrasound Guided Transversus Abdominis Plane Block in Pain Control After Hepatectomy
Length of stay in hospital
Assess length of stay from admission to discharge
Quality of Life Questionnaire (at 1 week and 1 month post discharge) (EQ5DL)
1 week (up to 7 days) and 1 month up to 30 days post discharge from hospital
Contact the study team to confirm eligibility.
Primary Completion
November 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 28, 2022
Record last verified: 2022-06
Paper will be published in surgical journals
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Source: ClinicalTrials.gov.
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