A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty
NCT ID: NCT02444260
Last Updated: 2015-05-14
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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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2013-12-31
2016-12-31
Brief Summary
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Specific study objectives are to determine the effect of conscious sedation on:
(i) patient satisfaction (ii) postoperative pain (iii) time to discharge (iv) intraoperative complications (v) postoperative functional status (vi) short-term postoperative complications (vii) long-term postoperative complications
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intravenous Normal Saline
Intravenous Normal Saline plus Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg ; Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus i
Intravenous Normal Saline
Intravenous normal saline will be infused by non-blinded anaesthetist
Bupivocaine
Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg
Lignocaine HCl
Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg
Midazolam
Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus Midazolam - administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg.
Midazolam
Midazolam will administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg. Additional sedation will be given to achieve and maintain a score of 2-3 on the Ramsay sedation scale during the procedure, up to the maximum dose of 10mg.
Bupivocaine
Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg
Lignocaine HCl
Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg
Interventions
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Midazolam
Midazolam will administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg. Additional sedation will be given to achieve and maintain a score of 2-3 on the Ramsay sedation scale during the procedure, up to the maximum dose of 10mg.
Intravenous Normal Saline
Intravenous normal saline will be infused by non-blinded anaesthetist
Bupivocaine
Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg
Lignocaine HCl
Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Body mass index \< 18.5 kg/m2 or \> 30 kg/m2
* Recurrent inguinal hernias
* Bilateral inguinal hernias
* Large inguinoscrotal hernias
* Incarcerated hernia
* Allergies to local anaesthetic and sedative agents
* Pregnancy
* Lactation
* Chronic pain syndromes
* Anxiety disorders
* Marijuana use
* Long term use of opioid or sedative agents
18 Years
75 Years
ALL
No
Sponsors
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The University of The West Indies
OTHER
Responsible Party
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Locations
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University of the West Indies, mona
Kingston, Please Select, Jamaica
Countries
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Central Contacts
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Facility Contacts
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References
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Leake PA, Toppin PJ, Reid M, Plummer JM, Roberts PO, Harding-Goldson H, McFarlane ME. Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2017 Feb 7;6(2):e20. doi: 10.2196/resprot.6754.
Other Identifiers
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ECP342,12/13
Identifier Type: -
Identifier Source: org_study_id
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