NCT04878926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
Last Updated

May 10, 2021

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

May 2, 2021

Last Update Submit

May 5, 2021

Conditions

Transversus Abdominis Plane (TAP) Block

Keywords

AnesthesiaEndoscopicPercutaneous gastrostomySedationTAP block

Outcome Measures

Primary Outcomes (1)

  • Successful completion of the operation

    Successful placement of percutaneous endoscopic gastrostomy Tube

    20 minutes after introducing the endoscope in the patient mouth

Secondary Outcomes (7)

  • Mean and Standard deviation of Heart Rate (beat/minute)(mean±SD)

    30 minutes after patients entered the endoscopy room

  • Mean and Standard deviation of Blood Pressure (mmHg)(mean±SD)

    30 minutes after patients entered the endoscopy room

  • Mean and Standard deviation of Oxygen Saturation (SpO2) (%)(mean±SD)

    30 minutes after patients entered the endoscopy room

  • Number of participants and Rate of Anesthesia-related Complications

    24 hours after the end of operation

  • Median and Range of Numeric Pain Rating Scale (NPRS)

    24 hours after the end of operation

  • +2 more secondary outcomes

Study Arms (2)

Group A (n=30)

ACTIVE COMPARATOR

IV Sedation + TAP block

Procedure: IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block

Group B (n=30)

ACTIVE COMPARATOR

IV Sedation + LA infiltration

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

Interventions

IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP blockPROCEDURE

IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block

Group A (n=30)
IV midazolam and propofol-based sedation with Local Anesthetic infiltrationPROCEDURE

IV midazolam and propofol-based sedation with Local Anesthetic infiltration

Group B (n=30)

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring long-term nutritional support
  • American Society of Anesthesiologists (ASA) physical status II-III
  • Age ≥ 6 years

You may not qualify if:

  • American Society of Anesthesiologists (ASA) physical status \> III
  • Patients younger than 6 years
  • Previous PEG placement
  • Allergy to local anesthetics
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Location

MeSH Terms

Conditions

Bites and Stings

Interventions

Midazolam

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ahmed M Shaat

    Damanhour Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2021

First Posted

May 10, 2021

Study Start

August 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 10, 2021

Record last verified: 2018-03

Locations

EG(1)