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Completed

NCT Number: NCT03394807

LaGRA Trial in Laparoscopic Cholecystectomy

This study investigated the effectiveness of a surgeon administered, laparoscopic guided, regional anaesthesia technique.

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Key information

Conditions

Regional Anesthesia Morbidity Biliary Tract Diseases Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallbladder Stone Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

A prospective, double blind, randomised controlled trial was performed. Consenting patients undergoing laparoscopic cholecystectomy were randomised, by envelope, to a laparoscopic guided 2-point blockade (subcostal transversus abdominis plane and rectus sheath) using either Chirocaine® 2.5mg/ml (LaGRA) or 0.9% Saline (Placebo) after specimen extraction.

Primary endpoints were post-operative pain in the first 6 hours. Secondary endpoints were analgesic/anti-emetic usage and day case and re-admission rates. Data was analysed using GraphPad Prism (V7).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing laparoscopic cholecystectomy
  • ASA I, II or III

Exclusion criteria

  • Patients that don't consent to be included
  • Allergy to levobupivacaine

Treatment and study plan

Levobupivacaine

Drug

Levobupivacaine injection to Transversus abdominis plane and rectus sheath

Other names: Chirocaine

Placebo

Drug

Saline injection to Transversus abdominis plane and rectus sheath

Other names: Saline

Primary outcomes

  1. Post operative pain score

    Time frame: 6 hours post operatively

    Visual analogue pain scores ranging from 0 to 10

Secondary outcomes

  1. Opioid use

    Time frame: Perioperative period including first 6 hours post operatively

    Amount (mg) of opioid medication administered

  2. Analgesic use

    Time frame: Perioperative period including first 6 hours post operatively

    Type and dose of all non opioid analgesic medications prescribed

  3. Readmission rate

    Time frame: 30 days post operative

    Patient readmitted to hospital for any reason

  4. Daycase rates

    Time frame: Day of surgery

    Patient that was planned for daycase but admitted overnight

Sponsors and collaborators

Lead sponsor

Health Service Executive, Ireland

Other

Registry information

Official study title

Laparoscopic Guided Regional Analgesia (LaGRA) Reduces Post Operative Pain After Laparoscopic Cholecystectomy - a Randomised, Controlled Trial.

Acronym: LaGRA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2018
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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