Laparoscopic-Assisted Transversus Abdominus Plane Block Versus Intraperitoneal Irrigation of Local Anesthetic for Patients Undergoing Laparoscopic Cholecystectomy

NCT06714279 | Recruiting Phase 1 DMC

• 1 other identifier: 24.71
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being performed to investigate whether the administration of local anaesthetic into the muscles in the abdomen or onto squirting the local anaesthetic onto the liver following keyhole gallbladder surgery is more beneficial in reducing pain post-operatively. Keyhole gallbladder surgery is typically performed under general anaesthesia (or while the patient is 'fully asleep'), however doctors use other pain relief types to reduce pain after the operation. One of these options is local anaesthetic, which involves the injection of an medication into or onto the part of the body which has been operated on. The reason for doing this is to reduce the pain felt by the patient in the part if the body where the operation occurred. The best way of using these medications remain unclear. The local anaesthetic being used in the study is fully approved for use in Ireland and the drug itself is not being tested. In other words, the drug is not an experimental drug. Local anaesthetic drugs are given in different ways in patients who have just had the keyhole surgery on their gall bladder (this is the surgery that you are about to have). Therefore, the aim of this study is to compare two ways of giving patients these local anaesthetic medications following key-hole gallbladder surgery. These include (1) injecting the medication into the skin at the surgical wounds and squirting it onto the liver (where the gallbladder has been removed from), or (2) injecting the medication into the skin at the surgical wounds and into the muscles in the abdomen (known formally as a transversus abdominus plane block).

Conditions

Laparoscopic Cholecystectomy; TAP Block; Local Anesthetic

Keywords

Laparoscopic cholecystectomy; TAP block; Transversus abdominus plane block; Local anesthetic

Outcome Measures

Primary Outcomes (1)

• Post operative pain measured via Visual Anaolgue Scores

  The primary objective for the study is to quantify and analyse differences in the post-operative resting and shoulder tip pain as measured using VAS at 1-hour, 3-hours, 6-hours, 12-hours and 24-hours following laparoscopic cholecystectomy. Thereafter, the further opioid analgesic requirements for each patient will be recorded for the duration of their inpatient stay and also the total sum of opioids prescribed for these patients on discharge (measured using morphine equivalents).

  1-hour, 3-hours, 6-hours, 12-hours and 24-hours

Study Arms (2)

Study Group - Tap Block

OTHER

Study Group: Study group: Laparoscopic Transversus Abdominis Plane in four points: above the umbilicus on the left side; dose calculation 2.5mg per body weight. After the cholecystectomy 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.

Drug: Tap Block - Bupivacaine

Control Group - Intraperitoneal Local Anesthetic onto Liver

PLACEBO COMPARATOR

Administration of local anesthetic to the liver using, dose calculation 2.5mg per body weight.

Drug: Intraperitoneal infiltration to liver

Interventions

Tap Block - Bupivacaine DRUG

The medicinal product for both groups is the same - Bupivacaine. The mode of administration is what this study is reviewing: Control group (Intraperitoneal infiltration to liver) and Study Group - Laparoscopic Transversus Abdominis Plane Block (LTap Block)

Study Group - Tap Block

Intraperitoneal infiltration to liver DRUG

The medicinal product for both groups is the same - Bupivacaine. The mode of administration is what this study is reviewing: Control group (Intraperitoneal infiltration to liver) and Study Group - Laparoscopic Transversus Abdominis Plane Block (LTap Block)

Control Group - Intraperitoneal Local Anesthetic onto Liver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 years or older will be considered for recruitment into this study if they are indicated to undergo elective laparoscopic cholecystectomy

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Beaumont Hospital

Dublin, Ireland

RECRUITING

Study Officials

• Arnold DK Hill, MB MCh FRCS

  RCSI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew G Davey, MB BCh BAO MCh MRCSI PhD

CONTACT

+353180320000; matthewdavey21@rcsi.ie

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar in General Surgery

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: December 3, 2024
• Study Start: March 12, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

IE (1)