RecruitingPhase 1NCT06714279

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

Laparoscopic-Assisted Transversus Abdominus Plane Block Versus Intraperitoneal Irrigation of Local Anesthetic for Patients Undergoing Laparoscopic Cholecystectomy - A Prospective, Randomised Clinical Trial


Sponsor

Royal College of Surgeons, Ireland

Enrollment

144 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria1

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

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Interventions

DRUGTap Block - Bupivacaine

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)

DRUGIntraperitoneal infiltration to liver

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)


Locations(1)

Beaumont Hospital

Dublin, Ireland

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NCT06714279


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