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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 May 2015 |
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Main ID: |
NCT02444260 |
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Date of registration:
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28/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty
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Scientific title:
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Improving Patient Outcomes With Inguinal Hernioplasty - a Randomized Controlled Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation |
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Date of first enrolment:
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December 2013 |
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Target sample size:
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180 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02444260 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Jamaica
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Contacts
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Name:
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Pierre Leake, DM |
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Address:
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Telephone:
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Email:
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Pierre-Anthony Leake |
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Affiliation:
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Name:
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Pierre Leake, DM |
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Address:
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Telephone:
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Email:
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Pierre-Anthony Leake |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Reducible inguinal hernia
Exclusion Criteria:
- Renal, hepatic, respiratory, cardiovascular, neurologic or psychiatric disease
- 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Conscious Sedation
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Anesthesia, Local
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Inguinal Hernia
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Intervention(s)
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Drug: Intravenous Normal Saline
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Drug: Lignocaine HCl
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Drug: Midazolam
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Drug: Bupivocaine
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Primary Outcome(s)
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patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale
[Time Frame: 1 year]
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Secondary Outcome(s)
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Frequency (total count) of postoperative complications using a questionaire
[Time Frame: 1 year]
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Post-operative assessment of physical activity using Activities Assessment Scale
[Time Frame: 1 year]
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change in postoperative pain score from baseline assessed with visual analog scale
[Time Frame: 1 year]
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Time to discharge
[Time Frame: 2 weeks]
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Operative time
[Time Frame: 2 weeks]
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Secondary ID(s)
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ECP342,12/13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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