Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
76 participants
INTERVENTIONAL
2016-10-01
2017-08-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LaGRA
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
Levobupivacaine
Levobupivacaine injection to Transversus abdominis plane and rectus sheath
Placebo
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
Placebo
Saline injection to Transversus abdominis plane and rectus sheath
Interventions
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Levobupivacaine
Levobupivacaine injection to Transversus abdominis plane and rectus sheath
Placebo
Saline injection to Transversus abdominis plane and rectus sheath
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA I, II or III
Exclusion Criteria
* Allergy to levobupivacaine
16 Years
ALL
No
Sponsors
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Health Service Executive, Ireland
OTHER
Responsible Party
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Des Toomey
Consultant Surgeon
Other Identifiers
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LaGRA-MRHM
Identifier Type: -
Identifier Source: org_study_id
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