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

Study Overview
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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.

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

Conditions
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Transversus Abdominis Plane (TAP) Block

Intervention / Treatment
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* 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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (n=30)<br>IV Sedation + TAP block | Procedure: IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block<br>* IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block<br>|
| Active Comparator: Group B (n=30)<br>IV Sedation + LA infiltration | Procedure: IV midazolam and propofol-based sedation with Local Anesthetic infiltration<br>* IV midazolam and propofol-based sedation with Local Anesthetic infiltration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful completion of the operation | Successful placement of percutaneous endoscopic gastrostomy Tube | 20 minutes after introducing the endoscope in the patient mouth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean and Standard deviation of Heart Rate (beat/minute)(mean±SD) | After patients entered the endoscopy room (T0), 10 minutes after beginning of operation (T1), and at PACU (T2) | 30 minutes after patients entered the endoscopy room | 
| Mean and Standard deviation of Blood Pressure (mmHg)(mean±SD) | After patients entered the endoscopy room (T0), 10 minutes after beginning of operation (T1), and at PACU (T2) | 30 minutes after patients entered the endoscopy room | 
| Mean and Standard deviation of Oxygen Saturation (SpO2) (%)(mean±SD) | After patients entered the endoscopy room (T0), 10 minutes after beginning of operation (T1), and at PACU (T2) | 30 minutes after patients entered the endoscopy room | 
| Number of participants and Rate of Anesthesia-related Complications | Number of participants and Rate of: Hypertension or Hypotension (increase or decrease in blood pressure by 20% from baseline); Tachycardia (Heart Rate > 100 beat/minute) or Bradycardia (Heart Rate < 60 beat/minute); Any cardiac arrhythmias; Hypoxemia (Oxygen desaturation, SpO2 < 90%), Failure of TAP block, Local Anesthetic toxicity, Intraperitoneal injection and Bowel injury | 24 hours after the end of operation | 
| Median and Range of Numeric Pain Rating Scale (NPRS) | NPRS measures the severity of pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2 hours, and 24 hours after operation) | 24 hours after the end of operation | 
| Mean and Standard deviation of Hospital stay duration (hour)(mean±SD) | Time interval from entering the hospital till discharge | 48 hours after entering the endoscopy unit | 
| Number of participants and Rate of Patients' Satisfaction of the service | YES/NO questionnaire for Patients' Satisfaction of the service | 48 hours after entering the endoscopy unit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Endoscopic, Percutaneous gastrostomy, Sedation, TAP block