Laparoscopic Transversus Abdominis Plane Block (LTAP) for Appendicectomy Versus Standard Port Site Treatment

NCT05427266 | Unknown DMC

• 1 other identifier: 22/31
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pain; Appendicitis; Surgery; Analgesia; Laparoscopic; Bupivacaine

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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

• 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

Study Arms (2)

Study Group - Tap Block

OTHER

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 Once the needle tip is seen, it is withdrawn slowly and gently about 0.5cm above/superficial to the transversus abdominis (TA) muscle.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.

Other: Tap Block - Bupivacaine

Control Group - Standard port site infiltration

OTHER

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

Other: Tap Block - Bupivacaine

Interventions

Tap Block - Bupivacaine OTHER

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)

Control Group - Standard port site infiltration; Study Group - Tap Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide signed and dated informed consent form
• Willing to comply with all study procedures and be available for follow up telephone follow up
• Male or female, aged over 18
• Diagnosed either clinically or radiologically (CT/US/MRI) with appendicitis
• Uncomplicated or complicated appendicitis
• Undergoing laparoscopic appendicitis surgery only
• Must be fluent in English in order to complete telephone follow up questionnaire
• Fulfillment of each criteria must be clearly evidenced (in lab reports or correspondence) and/or documented in the medical records.

You may not qualify if:

• Male or female under the age or 18
• Laparoscopic converted to open appendicectomy (during surgical procedure)
• Open appendicectomy (planned)
• Pregnancy.
• Females must not be breastfeeding
• Known allergic reactions to components of the study product(s) )
• Not fluent in English - which would prevent participants to complete follow up telephone questionnaire
• Malignant appendicitis
• Spinal Anaesthesia, Epidural analgesia catheter or injections, Post-operative requirements for patient controlled analgesia (PCA)
• Right hemicolectomy or any concomitant or simultaneous intervention
• Allergy or hypersensitivity to any of the components of Bupivacaine
• Presence of any other illness or condition that renders the patient unsuitable for trial participation in the opinion of the investigator

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Related Publications (1)

• 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.

  PMID: 41511871 DERIVED

MeSH Terms

Conditions

Pain; Appendicitis; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Arnold Hill

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sorcha O'Grady

CONTACT

0873156654; sorchaogrady@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single blinded randomised control trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi centre Single blinded randomised control trial.

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 22, 2022
• Study Start: July 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after close of study when analyses is completed
• Access Criteria: All findings will be published in surgical journals