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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine | Drug | Levobupivacaine injection to Transversus abdominis plane and rectus sheath |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post operative pain score | Visual analogue pain scores ranging from 0 to 10 | 6 hours post operatively |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D041761 | Cholecystolithiasis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Prospective, randomised, placebo controlled trial
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Blinded
| Placebo | Drug | Saline injection to Transversus abdominis plane and rectus sheath |
|
|
| 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 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |