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

Condition(s) studied

Investigational drug(s) / intervention(s)

Tap 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)

Intraperitoneal 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)

Study 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

Primary outcome measure(s)

• Post operative pain measured via Visual Anaolgue Scores — 1-hour, 3-hours, 6-hours, 12-hours and 24-hours
  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).

Trial sites (1)

More Royal College of Surgeons, Ireland trials in Ireland