LaGRA Trial in Laparoscopic Cholecystectomy

Health Service Executive (HSE)

Status and phase: Completed; Phase 4

Conditions: Regional Anesthesia Morbidity; Pain; Gallbladder Stone

Treatments: Drug: Placebo; Drug: Levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03394807

LaGRA-MRHM

Details and patient eligibility

About

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

Full 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).

Enrollment: 76 patients

Sex: All

Ages: 16+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

LaGRA

Experimental group

Description:

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

Treatment:

Drug: Levobupivacaine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo