LaGRA Trial in Laparoscopic Cholecystectomy

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03394807

Acronym

LaGRA

Enrollment

Registered

2018-01-09

Start date

2016-10-01

Completion date

2017-08-30

Last updated

2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallbladder Stone, Pain, Regional Anesthesia Morbidity

Brief summary

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

Detailed description

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).

Interventions

DRUGLevobupivacaine

Levobupivacaine injection to Transversus abdominis plane and rectus sheath

DRUGPlacebo

Saline injection to Transversus abdominis plane and rectus sheath

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Blinded

Intervention model description

Prospective, randomised, placebo controlled trial

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Post operative pain score	6 hours post operatively	Visual analogue pain scores ranging from 0 to 10

Secondary

Measure	Time frame	Description
Opioid use	Perioperative period including first 6 hours post operatively	Amount (mg) of opioid medication administered
Analgesic use	Perioperative period including first 6 hours post operatively	Type and dose of all non opioid analgesic medications prescribed
Readmission rate	30 days post operative	Patient readmitted to hospital for any reason
Daycase rates	Day of surgery	Patient that was planned for daycase but admitted overnight

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026