Transversus Abdominis Plane (TAP) BlockNCT04878926

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

A study testing IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block and IV midazolam and propofol-based sedation with Local Anesthetic infiltration in people with Transversus Abdominis Plane (TAP) Block, run by Damanhour Teaching Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 6 years and older
Conditions the study is for: Transversus Abdominis Plane (TAP) Block
What is being tested?: IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block and IV midazolam and propofol-based sedation with Local Anesthetic infiltration
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 1 Aug 2017to 1 Mar 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Damanhour Teaching Hospital
Damanhūr, El-Beheira

Other trials in Egypt

About this study

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.

Conditions: Transversus Abdominis Plane (TAP) Block
Being tested: IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block, IV midazolam and propofol-based sedation with Local Anesthetic infiltration
Keywords: Anesthesia, Endoscopic, Percutaneous gastrostomy, Sedation, TAP block
Medical subject headings: Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP blockProcedure or surgery
IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block
IV midazolam and propofol-based sedation with Local Anesthetic infiltrationProcedure or surgery
IV midazolam and propofol-based sedation with Local Anesthetic infiltration

Study groups in NCT04878926
Study group	Role	What they receive
Group A (n=30)	Active comparator	IV Sedation + TAP block Receives: 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 Receives: Procedure: IV midazolam and propofol-based sedation with Local Anesthetic infiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

Successful completion of the operation
Successful placement of percutaneous endoscopic gastrostomy Tube
Measured: 20 minutes after introducing the endoscope in the patient mouth

Secondary outcomes (7)

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)
Measured: 30 minutes after patients entered the endoscopy room
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)
Measured: 30 minutes after patients entered the endoscopy room
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)
Measured: 30 minutes after patients entered the endoscopy room
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
Measured: 24 hours after the end of operation
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)
Measured: 24 hours after the end of operation
Mean and Standard deviation of Hospital stay duration (hour)(mean±SD)
Time interval from entering the hospital till discharge
Measured: 48 hours after entering the endoscopy unit
Number of participants and Rate of Patients' Satisfaction of the service
YES/NO questionnaire for Patients' Satisfaction of the service
Measured: 48 hours after entering the endoscopy unit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20171 Mar 2018

First posted10 May 2021
Study start1 Aug 2017
Primary completion1 Mar 2018
Study completion1 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Transversus Abdominis Plane (TAP) BlockStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04878926
Sponsor's protocol ID: DTH:18001
Status last verified: Mar 2018
First submitted: 2 May 2021
Last updated: 10 May 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Not yet recruiting
Subcostal TAP Block Versus Combined Subcostal TAP and Recto-Intercostal Fascial Plane Block for Analgesia After Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy, Postoperative Pain
Recruiting
Spinal Anesthesia Versus General Anesthesia Plus TAP Block for Laparoscopic Inguinal Hernia Repair
Transversus Abdominis Plane Block (TAP Block), Laparoscopic Inguinal Hernia Repair
Not yet recruiting
TAP vs. ESP Blocks for Post-Cesarean Analgesia
Postoperative Pain After Cesarean Section

All Transversus Abdominis Plane (TAP) Block trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IV Sedation Plus TAP Block for Placement of Percutaneous Endoscopic Gastrostomy Tube
ClinicalTrials.gov ID: NCT04878926
Acronym / sponsor ID: DTH:18001
Conditions: Transversus Abdominis Plane (TAP) Block
Keywords: Anesthesia, Endoscopic, Percutaneous gastrostomy, Sedation, TAP block
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Damanhour Teaching HospitalOther government
Study start: 1 Aug 2017 (actual)
Primary completion: 1 Mar 2018 (actual)
Study completion: 1 Mar 2018 (actual)
First posted: 10 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A (n=30)	Active comparator	Procedure: IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP blockIV Sedation + TAP block
Group B (n=30)	Active comparator	Procedure: IV midazolam and propofol-based sedation with Local Anesthetic infiltrationIV Sedation + LA infiltration

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP blockIV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block	Procedure or surgery	Group A (n=30)
IV midazolam and propofol-based sedation with Local Anesthetic infiltrationIV midazolam and propofol-based sedation with Local Anesthetic infiltration	Procedure or surgery	Group B (n=30)

Primary outcome

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

7 secondary outcomes

Mean and Standard deviation of Heart Rate (beat/minute)(mean±SD)
Time frame: 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
Mean and Standard deviation of Oxygen Saturation (SpO2) (%)(mean±SD)
Time frame: 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
Median and Range of Numeric Pain Rating Scale (NPRS)
Time frame: 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
Number of participants and Rate of Patients' Satisfaction of the service
Time frame: 48 hours after entering the endoscopy unit

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.

Related trials for Transversus Abdominis Plane (TAP) Block

Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Not yet recruiting
Subcostal TAP Block Versus Combined Subcostal TAP and Recto-Intercostal Fascial Plane Block for Analgesia After Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy, Postoperative Pain
Recruiting
Spinal Anesthesia Versus General Anesthesia Plus TAP Block for Laparoscopic Inguinal Hernia Repair
Transversus Abdominis Plane Block (TAP Block), Laparoscopic Inguinal Hernia Repair
Not yet recruiting
TAP vs. ESP Blocks for Post-Cesarean Analgesia
Postoperative Pain After Cesarean Section

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ahmed M Shaat principal investigator

Damanhour Teaching Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful completion of the operation (time frame: 20 minutes after introducing the endoscope in the patient mouth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04878926.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.