Transversus Abdominis Plane (TAP) Block
Conditions
Keywords
Anesthesia, Endoscopic, Percutaneous gastrostomy, Sedation, TAP block
Brief summary
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.
Interventions
PROCEDUREIV 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
PROCEDUREIV midazolam and propofol-based sedation with Local Anesthetic infiltration
IV midazolam and propofol-based sedation with Local Anesthetic infiltration
Sponsors
Damanhour Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful completion of the operation | 20 minutes after introducing the endoscope in the patient mouth | Successful placement of percutaneous endoscopic gastrostomy Tube |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean and Standard deviation of Blood Pressure (mmHg)(mean±SD) | 30 minutes after patients entered the endoscopy room | After patients entered the endoscopy room (T0), 10 minutes after beginning of operation (T1), and at PACU (T2) |
| Mean and Standard deviation of Oxygen Saturation (SpO2) (%)(mean±SD) | 30 minutes after patients entered the endoscopy room | After patients entered the endoscopy room (T0), 10 minutes after beginning of operation (T1), and at PACU (T2) |
| Number of participants and Rate of Anesthesia-related Complications | 24 hours after the end of operation | 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 |
| Mean and Standard deviation of Heart Rate (beat/minute)(mean±SD) | 30 minutes after patients entered the endoscopy room | After patients entered the endoscopy room (T0), 10 minutes after beginning of operation (T1), and at PACU (T2) |
| Mean and Standard deviation of Hospital stay duration (hour)(mean±SD) | 48 hours after entering the endoscopy unit | Time interval from entering the hospital till discharge |
| Number of participants and Rate of Patients' Satisfaction of the service | 48 hours after entering the endoscopy unit | YES/NO questionnaire for Patients' Satisfaction of the service |
| Median and Range of Numeric Pain Rating Scale (NPRS) | 24 hours after the end of operation | 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) |
Countries
Egypt
Outcome results
None listed