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NCT Number: NCT06808737

Efficacy of Transversus Abdominis Plane Block in Alleviating Acute Appendicitis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2025
Registry last updated
Jun 4, 2026

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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