LaGRA Trial in Laparoscopic Cholecystectomy

Pain Clinical Trial

— LaGRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394807
• Other study ID #: LaGRA-MRHM
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2017
• Last updated: January 8, 2018
• Start date: October 1, 2016
• Est. completion date: August 30, 2017

Study information

• Verified date: January 2018
• Source: Health Service Executive, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing laparoscopic cholecystectomy

• ASA I, II or III

Exclusion Criteria:

• Patients that don't consent to be included

• Allergy to levobupivacaine

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallbladder Stone
• Gallstones
• Pain
• Regional Anesthesia Morbidity

Intervention

Drug:
• Levobupivacaine
Levobupivacaine injection to Transversus abdominis plane and rectus sheath
• Placebo
Saline injection to Transversus abdominis plane and rectus sheath

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Health Service Executive, Ireland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain score	Visual analogue pain scores ranging from 0 to 10	6 hours post operatively
Secondary	Opioid use	Amount (mg) of opioid medication administered	Perioperative period including first 6 hours post operatively
Secondary	Analgesic use	Type and dose of all non opioid analgesic medications prescribed	Perioperative period including first 6 hours post operatively
Secondary	Readmission rate	Patient readmitted to hospital for any reason	30 days post operative
Secondary	Daycase rates	Patient that was planned for daycase but admitted overnight	Day of surgery