Efficacy of Transversus Abdominis Plane Block in Alleviating Acute Appendicitis

Not Applicable

Recruiting

• Conditions: Acute Appendicitis

• Registration Number: NCT06808737
• Lead Sponsor: Ankara City Hospital Bilkent

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.

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 randomly assigned to three groups. Randomization will be achieved by allocating the first 5 patients to the T-50 group, the second 5 patients to the TAP-50 group, and the third 5 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 Timeline

• Study Start: 2024-05-08
• Study First Submitted: 2024-08-14
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-05-08
• Study Completion: 2025-05-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Need for opioids (mg) for effective pain relief according to NRS	Approximately 1 year after study start date	Determination of whether TAP block reduces the need for opioids in the management of acute appendicitis pain in the emergency department.

Secondary Outcome Measures

Name	Time	Method
Pain assessed by NRS	Approximately 1 year after study start date	Evaluation of the effectiveness of multimodal pain control for acute appendicitis pain in the emergency department across different groups.

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey