- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06808737
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
105
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
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Yenimahalle
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Ankara, Yenimahalle, Turkey (Türkiye)
- Ankara City Hospital
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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
- 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 |
Intervention / Treatment |
|---|---|
|
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.
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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.
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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.
|
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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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total Perioperative Opioid Consumption
Time Frame: From ED admission up to 24 hours postoperatively.
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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.
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From ED admission up to 24 hours postoperatively.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Pain Intensity Scores
Time Frame: At spesific intervals (2,6,12 and 24 hours) following surgical completion.
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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.
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At spesific intervals (2,6,12 and 24 hours) following surgical completion.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
- Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.
- Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 4;67(5152):1419-1427. doi: 10.15585/mmwr.mm675152e1.
- Falch C, Vicente D, Haberle H, Kirschniak A, Muller S, Nissan A, Brucher BL. Treatment of acute abdominal pain in the emergency room: a systematic review of the literature. Eur J Pain. 2014 Aug;18(7):902-13. doi: 10.1002/j.1532-2149.2014.00456.x. Epub 2014 Jan 22.
- Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
- Freys JC, Bigalke SM, Mertes M, Lobo DN, Pogatzki-Zahn EM, Freys SM; PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy (ESRA). Perioperative pain management for appendicectomy: A systematic review and Procedure-specific Postoperative Pain Management recommendations. Eur J Anaesthesiol. 2024 Mar 1;41(3):174-187. doi: 10.1097/EJA.0000000000001953. Epub 2024 Jan 12.
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)
May 8, 2024
Primary Completion (Actual)
December 28, 2024
Study Completion (Actual)
December 28, 2024
Study Registration Dates
First Submitted
August 14, 2024
First Submitted That Met QC Criteria
January 29, 2025
First Posted (Actual)
February 5, 2025
Study Record Updates
Last Update Posted (Actual)
June 4, 2026
Last Update Submitted That Met QC Criteria
June 2, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Pathologic Processes
- Disease Attributes
- Intestinal Diseases
- Infections
- Digestive System Diseases
- Gastrointestinal Diseases
- Neurobehavioral Manifestations
- Gastroenteritis
- Perceptual Disorders
- Cecal Diseases
- Intraabdominal Infections
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Emergencies
- Agnosia
- Appendicitis
Other Study ID 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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