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

Transversus Abdominis Plane (TAP) Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878926
• Other study ID #: DTH:18001
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2018
• Source: Damanhour Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transversus Abdominis Plane (TAP) Block

Intervention

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

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital	Damanhur	El-Beheira

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful completion of the operation	Successful placement of percutaneous endoscopic gastrostomy Tube	20 minutes after introducing the endoscope in the patient mouth
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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