NCT03394807

LaGRA Trial in Laparoscopic Cholecystectomy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Health Service Executive, Ireland · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Regional Anesthesia Morbidity
• Gallbladder Stone
• Pain

Interventions

Type	Name	Description
DRUG	Levobupivacaine	Levobupivacaine injection to Transversus abdominis plane and rectus sheath
DRUG	Placebo	Saline injection to Transversus abdominis plane and rectus sheath

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-07-30
• Completion: 2017-08-30
• First posted: 2018-01-09
• Last updated: 2018-01-09