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

May 5, 2021 updated by: Damanhour Teaching Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Beheira
      • Damanhūr, El-Beheira, Egypt
        • Damanhour Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (n=30)
IV Sedation + TAP block
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
Active Comparator: Group B (n=30)
IV Sedation + LA infiltration
Procedure: IV midazolam and propofol-based sedation with Local Anesthetic infiltration
IV midazolam and propofol-based sedation with Local Anesthetic infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful completion of the operation
Time Frame: 20 minutes after introducing the endoscope in the patient mouth
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)
Time Frame: 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)
30 minutes after patients entered the endoscopy room
Mean and Standard deviation of Blood Pressure (mmHg)(mean±SD)
Time Frame: 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)
30 minutes after patients entered the endoscopy room
Mean and Standard deviation of Oxygen Saturation (SpO2) (%)(mean±SD)
Time Frame: 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)
30 minutes after patients entered the endoscopy room
Number of participants and Rate of Anesthesia-related Complications
Time Frame: 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
24 hours after the end of operation
Median and Range of Numeric Pain Rating Scale (NPRS)
Time Frame: 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)
24 hours after the end of operation
Mean and Standard deviation of Hospital stay duration (hour)(mean±SD)
Time Frame: 48 hours after entering the endoscopy unit
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
Time Frame: 48 hours after entering the endoscopy unit
YES/NO questionnaire for Patients' Satisfaction of the service
48 hours after entering the endoscopy unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour Teaching Hospital

Investigators

  • Principal Investigator: Ahmed M Shaat, Damanhour Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

May 2, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTH:18001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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