Clinical trial NCT04878926: IV Sedation Plus TAP Block for Placement of Percutaneous Endoscopic Gastrostomy Tube
Official title: IV Sedation Plus TAP Block for Placement of Percutaneous Endoscopic Gastrostomy Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transversus Abdominis Plane (TAP) Block
Keywords: Anesthesia
Endoscopic
Percutaneous gastrostomy
Sedation
TAP block
Lead sponsor: Damanhour Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2021-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Successful completion of the operation
timeFrame: 20 minutes after introducing the endoscope in the patient mouth
Secondary outcomes:
measure: Mean and Standard deviation of Heart Rate (beat/minute)(mean±SD)
timeFrame: 30 minutes after patients entered the endoscopy room
measure: Mean and Standard deviation of Blood Pressure (mmHg)(mean±SD)
timeFrame: 30 minutes after patients entered the endoscopy room
measure: Mean and Standard deviation of Oxygen Saturation (SpO2) (%)(mean±SD)
timeFrame: 30 minutes after patients entered the endoscopy room
measure: Number of participants and Rate of Anesthesia-related Complications
timeFrame: 24 hours after the end of operation
measure: Median and Range of Numeric Pain Rating Scale (NPRS)
timeFrame: 24 hours after the end of operation
measure: Mean and Standard deviation of Hospital stay duration (hour)(mean±SD)
timeFrame: 48 hours after entering the endoscopy unit
measure: Number of participants and Rate of Patients' Satisfaction of the service
timeFrame: 48 hours after entering the endoscopy unit
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital
state: El-Beheira
Study officials:
affiliation: Damanhour Teaching Hospital
name: Ahmed M Shaat
role: PRINCIPAL_INVESTIGATOR
References: