Efficacy of Transversus Abdominis Plane Block in Alleviating Acute Appendicitis

June 2, 2026 updated by: Ankara City Hospital Bilkent

Assessment of the Efficacy of Transversus Abdominis Plane Block in Alleviating Acute Appendicitis Pain in the Emergency Department

This study aims to evaluate the efficacy of Transversus Abdominis Plane (TAP) block in preoperative pain management for patients diagnosed with acute appendicitis who are scheduled for emergency surgery in the emergency department. The research seeks to assess the potential of TAP block in reducing pain intensity prior to surgical intervention among patients diagnosed with acute appendicitis in the emergency setting. The goal is to contribute insights that can enhance practical approaches to achieving optimal pain control for acute appendicitis patients in emergency department settings.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will include patients who present to the emergency department with abdominal pain, receive a diagnosis of acute appendicitis through history, physical examination, and imaging modalities, and are determined to undergo definitive surgery following general surgical consultation. Participants will be systematically allocated to three groups. Systemic allocation will be achieved by allocating the first 3 patients to the T-50 group, the second 3 patients to the TAP-50 group, and the third 3 patients to the TAP-100 group. Following treatment, patients' Numeric Rating Scale (NRS) scores will be recorded at 30, 60, and 120 minutes during rest, coughing, and heel tap. If the NRS score is above 5, rescue analgesia will be administered as a 50 mcg fentanyl intravenous infusion over 15 minutes. Subsequently, patient demographic data including age, gender, height, weight, BMI, comorbidities, and medications, as well as vital signs upon admission, complete blood count values, coagulation parameters, creatine kinase levels, appendicitis rupture/non-rupture status, planned laparoscopic/open surgery, Alvarado score, time to first rescue analgesia after baseline analgesia administration (minutes), total analgesic requirement in the emergency department (mg), and TAP block complications (hematoma, surgical site infection, intra-abdominal collection, intramuscular injection - myonecrosis) will be documented. Patient satisfaction will be assessed using a 5-point Likert scale. cutaneous sensory distribution will be assessed at 20 minutes following TAP block. Following this, operative duration (minutes), time to first rescue analgesia postoperatively (minutes), postoperative 2, 4, 6, 12, 24-hour nausea-vomiting (PONV) score, NRS scores during rest, coughing, and heel tap at postoperative 2, 4, 6, 12, 24 hours, cumulative analgesic medications at postoperative 2, 4, 6, 12, 24 hours, postoperative rescue antiemetic requirement, total analgesic cost, and length of hospital stay (days) will be recorded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ahmet Burak Erdem, Assoc. Prof.
  • Phone Number: +90 505 495 74 95
  • Email: drabe0182@gmail.com

Study Locations

  • Turkey (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye)
        • Ankara City 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with acute appendicitis in the emergency department and scheduled for definitive surgery following general surgical consultation: patients will have their Alvarado score calculated based on history, physical examination, and laboratory tests, and acute appendicitis will be confirmed by ultrasound and/or contrast-enhanced/non-contrast-enhanced abdominal CT.
  • Patients aged 18 and over
  • Patients who provide written consent

Exclusion Criteria:

  • Patients with abdominal wall anatomical abnormalities
  • Patients with known local anesthetic allergies
  • Body mass index > 30
  • Patients weighing less than 45 kg
  • Coagulopathy
  • Patients with opioid, alcohol, or substance addiction
  • Patients with skin infections at the site of local anesthetic application
  • Pregnant or breastfeeding patients
  • Hemodynamically unstable patients
  • Patients with liver or kidney failure
  • Patients with chronic pain disorders
  • Patients who have difficulty cooperating or have language barriers
  • Patients who do not provide written consent
  • Patients under 18 years of age

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: T-50
Participants in the T-50 group will receive a 100 cc isotonic 0.9% NaCl (normal saline) solution containing 50 mg tramadol as an intravenous infusion over 15 minutes at baseline.
Active Comparator: TAP-50
Participants in the TAP-50 group will receive the same intravenous tramadol infusion as the T-50 group at baseline, followed by a transversus abdominis plane (TAP) block.
Procedure: Transversus Abdominis Plane Blockage
Patient monitoring will be conducted, followed by the preparation of the skin with 10% povidone-iodine and ensuring appropriate draping. A high-frequency linear transducer will be placed transversely between the right iliac crest and subcostal margin along the midaxillary line. Structures visualized on ultrasound from superficial to deep include: skin, subcutaneous fat, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum. The TAP block will be performed in the transversus abdominis plane (TAP) between the internal oblique and transversus abdominis muscles. A 23-gauge, 60 mm blunt-tipped needle will be directed toward the TAP, and negative aspiration will be confirmed upon entry into the fascial layer. An injection of 20 mL of 0.25% bupivacaine, prepared by diluting 10 mL of 0.5% bupivacaine with 10 mL of normal saline, will be performed, followed by the visualization of the oval spread of bupivacaine in the TAP.
Active Comparator: TAP-100
Participants in the TAP-100 group will receive a 100 cc isotonic 0.9% NaCl solution containing 100 mg tramadol as an intravenous infusion over 15 minutes at baseline, followed by a TAP block.
Procedure: Transversus Abdominis Plane Blockage
Patient monitoring will be conducted, followed by the preparation of the skin with 10% povidone-iodine and ensuring appropriate draping. A high-frequency linear transducer will be placed transversely between the right iliac crest and subcostal margin along the midaxillary line. Structures visualized on ultrasound from superficial to deep include: skin, subcutaneous fat, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum. The TAP block will be performed in the transversus abdominis plane (TAP) between the internal oblique and transversus abdominis muscles. A 23-gauge, 60 mm blunt-tipped needle will be directed toward the TAP, and negative aspiration will be confirmed upon entry into the fascial layer. An injection of 20 mL of 0.25% bupivacaine, prepared by diluting 10 mL of 0.5% bupivacaine with 10 mL of normal saline, will be performed, followed by the visualization of the oval spread of bupivacaine in the TAP.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Perioperative Opioid Consumption
Time Frame: From ED admission up to 24 hours postoperatively.
The total quantity of opioid analgesics calculated in tramadol milligram or fentanyl microgram administered to the patient from the time of the TAP Block in the emergency department until 24 hours.
From ED admission up to 24 hours postoperatively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity Scores
Time Frame: At spesific intervals (2,6,12 and 24 hours) following surgical completion.
Pain levels assessed using the Numerical Rating Scales (NRS), where 0 repsesents no pain and 10 represents worst imaginable pain. Scores will be recorded at rest, during cough and during the heel drop test.
At spesific intervals (2,6,12 and 24 hours) following surgical completion.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ahmet Burak Erdem, Assoc. Prof., Ankara Etlik City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AEŞH-EK1-2024-0038

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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