Efficacy of Transversus Abdominis Plane Block in Alleviating Acute Appendicitis

NCT06808737 | Completed

• 1 other identifier: AEŞH-EK1-2024-0038
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Appendicitis

Keywords

Transversus Abdominis Plane block; Acute Appendicitis; Pain management; Emergency Department; Pain control; Analgesics, opioid; Bupivacaine; Analgesia

Outcome Measures

Primary Outcomes (1)

• Total Perioperative Opioid Consumption

  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 Outcomes (1)

• Postoperative Pain Intensity Scores

  At spesific intervals (2,6,12 and 24 hours) following surgical completion.

Study Arms (3)

T-50

NO INTERVENTION

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.

TAP-50

ACTIVE COMPARATOR

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

TAP-100

ACTIVE COMPARATOR

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

Interventions

Transversus Abdominis Plane Blockage PROCEDURE

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.

TAP-100; TAP-50

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 30605448 BACKGROUND

• 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.

  PMID: 24449533 BACKGROUND

• 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.

  PMID: 38214556 BACKGROUND

• 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.

  PMID: 29226150 BACKGROUND

• 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.

  PMID: 26827847 RESULT

MeSH Terms

Conditions

Appendicitis; Agnosia; Emergencies

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Ahmet Burak Erdem, Assoc. Prof.

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The surgeon performing the surgery, the anesthesiologist, the nurses, and the emergency medicine doctor filling out the case form will be blinded to the patient groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The 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. Patients will be randomly assigned to three groups.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: February 5, 2025
• Study Start: May 8, 2024
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2024
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

TU (1)