Trial | NCT03394807  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    76
This study investigated the effectiveness of a surgeon administered, laparoscopic guided, regional anaesthesia technique.
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).
Study Started
Oct 01
2016
Primary Completion
Jul 30
2017
Study Completion
Aug 30
2017
Last Update
Jan 09
2018

Drug Levobupivacaine

Levobupivacaine injection to Transversus abdominis plane and rectus sheath

  • Other names: Chirocaine

Drug Placebo

Saline injection to Transversus abdominis plane and rectus sheath

  • Other names: Saline

LaGRA Experimental

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

Placebo Placebo Comparator

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

Criteria 

Inclusion Criteria:

Patients undergoing laparoscopic cholecystectomy
ASA I, II or III

Exclusion Criteria:

Patients that don't consent to be included
Allergy to levobupivacaine
No Results Posted