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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03394807
Other study ID # LaGRA-MRHM
Secondary ID
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
Health authority
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

Study Design


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
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