IV Sedation Plus TAP Block for Placement of Percutaneous Endoscopic Gastrostomy Tube
NCT ID: NCT04878926
Last Updated: 2021-05-10
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
NA
60 participants
INTERVENTIONAL
2017-08-01
2018-03-01
Brief Summary
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Background: The procedure used to be done with general anesthesia or IV sedation with LA infiltration, but the use of IV sedation with TAP block may be another option.
Patients and Methods: This was a prospective randomized study including 60 patients, requiring long-term nutritional support, underwent the PEG procedure at the GIT endoscopy unit at our Hospital. Patients were randomly allocated into two equal groups, in group A; procedures were performed with IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block, while in group B; procedures were performed with IV midazolam and propofol-based sedation with LA infiltration.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Group A (n=30)
IV Sedation + TAP block
IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block
IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block
Group B (n=30)
IV Sedation + LA infiltration
IV midazolam and propofol-based sedation with Local Anesthetic infiltration
IV midazolam and propofol-based sedation with Local Anesthetic infiltration
Interventions
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IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block
IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block
IV midazolam and propofol-based sedation with Local Anesthetic infiltration
IV midazolam and propofol-based sedation with Local Anesthetic infiltration
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) physical status II-III
* Age ≥ 6 years
Exclusion Criteria
* Patients younger than 6 years
* Previous PEG placement
* Allergy to local anesthetics
* Patient refusal
6 Years
ALL
No
Sponsors
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Damanhour Teaching Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Ahmed M Shaat
Role: PRINCIPAL_INVESTIGATOR
Damanhour Teaching Hospital
Locations
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Damanhour Teaching Hospital
Damanhūr, El-Beheira, Egypt
Countries
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Other Identifiers
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DTH:18001
Identifier Type: -
Identifier Source: org_study_id
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