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

Not Applicable

Completed

• Conditions: Transversus Abdominis Plane (TAP) Block
• Interventions: 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

• Registration Number: NCT04878926
• Lead Sponsor: Damanhour Teaching Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Status Verified: 2018-03
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Study First Submitted: 2021-05-02
• Study First Submitted QC: 2021-05-05
• Last Update Submitted: 2021-05-05
• Study First Posted: 2021-05-10
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (n=30)	IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block	IV Sedation + TAP block
Group B (n=30)	IV midazolam and propofol-based sedation with Local Anesthetic infiltration	IV Sedation + LA infiltration

Primary Outcome Measures

Name	Time	Method
Successful completion of the operation	20 minutes after introducing the endoscope in the patient mouth	Successful placement of percutaneous endoscopic gastrostomy Tube

Secondary Outcome Measures

Name	Time	Method
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 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)
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)
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
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
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)
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

Trial Locations

Locations (1)

Damanhour Teaching Hospital; 🇪🇬 Damanhūr, El-Beheira, Egypt