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

Damanhour Teaching Hospital

Status: Completed

Conditions: Transversus Abdominis Plane (TAP) Block

Treatments: Procedure: IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block; Procedure: IV midazolam and propofol-based sedation with Local Anesthetic infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT04878926

DTH:18001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Group A (n=30)

Active Comparator group

Description:

IV Sedation + TAP block

Treatment:

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

Group B (n=30)

Active Comparator group

Description:

IV Sedation + LA infiltration

Treatment:

Procedure: IV midazolam and propofol-based sedation with Local Anesthetic infiltration