LaGRA Trial in Laparoscopic Cholecystectomy

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

Detailed Description
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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).

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

Conditions
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Regional Anesthesia Morbidity, Gallbladder Stone, Pain

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing laparoscopic cholecystectomy ASA I, II or III Exclusion Criteria: Patients that don't consent to be included Allergy to levobupivacaine

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomised, placebo controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LaGRA<br>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 | Drug: Levobupivacaine<br>* Levobupivacaine injection to Transversus abdominis plane and rectus sheath<br>* Other names: Chirocaine;|
| Placebo Comparator: Placebo<br>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 | Drug: Placebo<br>* Saline injection to Transversus abdominis plane and rectus sheath<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain score | Visual analogue pain scores ranging from 0 to 10 | 6 hours post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use | Amount (mg) of opioid medication administered | Perioperative period including first 6 hours post operatively | 
| Analgesic use | Type and dose of all non opioid analgesic medications prescribed | Perioperative period including first 6 hours post operatively | 
| Readmission rate | Patient readmitted to hospital for any reason | 30 days post operative | 
| Daycase rates | Patient that was planned for daycase but admitted overnight | Day of surgery |