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Completed

NCT Number: NCT04878926

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

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.

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Key information

Conditions

Transversus Abdominis Plane (TAP) Block Bites and Stings Chemically-Induced Disorders Poisoning Wounds and Injuries

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

IV midazolam and propofol-based sedation with Local Anesthetic infiltration

Procedure

IV midazolam and propofol-based sedation with Local Anesthetic infiltration

Primary outcomes

  1. Successful completion of the operation

    Time frame: 20 minutes after introducing the endoscope in the patient mouth

    Successful placement of percutaneous endoscopic gastrostomy Tube

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Damanhour Teaching Hospital

Other Gov

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 10, 2021
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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