Back to resultsLaGRA Trial in Laparoscopic Cholecystectomy (LaGRA)
Primary Purpose
Regional Anesthesia Morbidity, Gallbladder Stone, Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Levobupivacaine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Regional Anesthesia Morbidity
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LaGRA
Placebo
Arm 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
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
Outcomes
Primary Outcome Measures
Post operative pain score
Visual analogue pain scores ranging from 0 to 10
Secondary Outcome Measures
Opioid use
Amount (mg) of opioid medication administered
Analgesic use
Type and dose of all non opioid analgesic medications prescribed
Readmission rate
Patient readmitted to hospital for any reason
Daycase rates
Patient that was planned for daycase but admitted overnight
Full Information
NCT ID
NCT03394807
First Posted
December 15, 2017
Last Updated
January 8, 2018
Sponsor
Health Service Executive, Ireland
1. Study Identification
Unique Protocol Identification Number
NCT03394807
Brief Title
LaGRA Trial in Laparoscopic Cholecystectomy
Acronym
LaGRA
Official Title
Laparoscopic Guided Regional Analgesia (LaGRA) Reduces Post Operative Pain After Laparoscopic Cholecystectomy - a Randomised, Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Service Executive, Ireland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia Morbidity, Gallbladder Stone, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomised, placebo controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinded
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LaGRA
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Other Intervention Name(s)
Chirocaine
Intervention Description
Levobupivacaine injection to Transversus abdominis plane and rectus sheath
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Saline injection to Transversus abdominis plane and rectus sheath
Primary Outcome Measure Information:
Title
Post operative pain score
Description
Visual analogue pain scores ranging from 0 to 10
Time Frame
6 hours post operatively
Secondary Outcome Measure Information:
Title
Opioid use
Description
Amount (mg) of opioid medication administered
Time Frame
Perioperative period including first 6 hours post operatively
Title
Analgesic use
Description
Type and dose of all non opioid analgesic medications prescribed
Time Frame
Perioperative period including first 6 hours post operatively
Title
Readmission rate
Description
Patient readmitted to hospital for any reason
Time Frame
30 days post operative
Title
Daycase rates
Description
Patient that was planned for daycase but admitted overnight
Time Frame
Day of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
LaGRA Trial in Laparoscopic Cholecystectomy
We'll reach out to this number within 24 hrs