A Phase 4 interventional study of Levobupivacaine and Placebo in Regional Anesthesia Morbidity, Gallbladder Stone and Pain, sponsored by Health Service Executive, Ireland. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-01-09.
Sponsored by Health Service Executive, Ireland · Phase 4, Interventional, and Treatment
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).
88 studies on the registry are indexed under Cholecystolithiasis; 17 are open to participants now.
This study's enrollment of 76 is below the median of 100 across 59 interventional studies indexed under Cholecystolithiasis.
Browse Cholecystolithiasis studies →Health Service Executive, Ireland is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Levobupivacaine injection to Transversus abdominis plane and rectus sheath
Also known as: Chirocaine
Saline injection to Transversus abdominis plane and rectus sheath
Also known as: Saline
Post operative pain score
Visual analogue pain scores ranging from 0 to 10
Time frame: 6 hours post operatively
Opioid use
Amount (mg) of opioid medication administered
Time frame: Perioperative period including first 6 hours post operatively
Analgesic use
Type and dose of all non opioid analgesic medications prescribed
Time frame: Perioperative period including first 6 hours post operatively
Readmission rate
Patient readmitted to hospital for any reason
Time frame: 30 days post operative
Daycase rates
Patient that was planned for daycase but admitted overnight
Time frame: Day of surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2016 to primary completion in Jul 2017, 9 months.
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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Levobupivacaine
Health Service Executive, Ireland