LaGRA Trial in Laparoscopic Cholecystectomy

NCT ID: NCT03394807

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-08-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Regional Anesthesia Morbidity Gallbladder Stone Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomised, placebo controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Blinded

Study Groups

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LaGRA

regional anaesthesia of the right upper quadrant by injection of levobupivacaine 0.25% to the transversus abdominis plane and the rectus sheath under laparoscopic guidance immediately following specimen removal

Group Type EXPERIMENTAL

Levobupivacaine

Intervention Type DRUG

Levobupivacaine injection to Transversus abdominis plane and rectus sheath

Placebo

Sham regional anaesthesia of the right upper quadrant by injection of Saline 0.9% to the transversus abdominis plane and the rectus sheath under laparoscopic guidance immediately following specimen removal

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline injection to Transversus abdominis plane and rectus sheath

Interventions

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Levobupivacaine

Levobupivacaine injection to Transversus abdominis plane and rectus sheath

Intervention Type DRUG

Placebo

Saline injection to Transversus abdominis plane and rectus sheath

Intervention Type DRUG

Other Intervention Names

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Chirocaine Saline

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Service Executive, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Des Toomey

Consultant Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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LaGRA-MRHM

Identifier Type: -

Identifier Source: org_study_id

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