IV Sedation Plus TAP Block for Placement of Percutaneous Endoscopic Gastrostomy Tube

NCT ID: NCT04878926

Last Updated: 2021-05-10

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-03-01

Brief Summary

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Objective: To determine the effectiveness and safety of IV sedation combined with ultrasound-guided, left side transversus abdominis plane (TAP) block versus combination with local anesthetic (LA) infiltration for Percutaneous Endoscopic Gastrostomy (PEG) tube placement.

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.

Detailed Description

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Conditions

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Transversus Abdominis Plane (TAP) Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A (n=30)

IV Sedation + TAP block

Group Type ACTIVE_COMPARATOR

IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block

Intervention Type PROCEDURE

IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block

Group B (n=30)

IV Sedation + LA infiltration

Group Type ACTIVE_COMPARATOR

IV midazolam and propofol-based sedation with Local Anesthetic infiltration

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

IV midazolam and propofol-based sedation with Local Anesthetic infiltration

IV midazolam and propofol-based sedation with Local Anesthetic infiltration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients requiring long-term nutritional support
* American Society of Anesthesiologists (ASA) physical status II-III
* Age ≥ 6 years

Exclusion Criteria

* American Society of Anesthesiologists (ASA) physical status \> III
* Patients younger than 6 years
* Previous PEG placement
* Allergy to local anesthetics
* Patient refusal
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damanhour Teaching Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Egypt

Other Identifiers

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DTH:18001

Identifier Type: -

Identifier Source: org_study_id

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