Clinical trial NCT06808737: Efficacy of Transversus Abdominis Plane Block in Alleviating Acute Appendicitis
Official title: Assessment of the Efficacy of Transversus Abdominis Plane Block in Alleviating Acute Appendicitis Pain in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Appendicitis
Keywords: Transversus Abdominis Plane block
Acute Appendicitis
Pain management
Emergency Department
Pain control
Analgesics, opioid
Bupivacaine
Analgesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Need for opioids (mg) for effective pain relief according to NRS
timeFrame: Approximately 1 year after study start date
Secondary outcomes:
measure: Pain assessed by NRS
timeFrame: Approximately 1 year after study start date
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
state: Yenimahalle
Study officials:
affiliation: Ankara Etlik City Hospital
name: Ahmet Burak Erdem, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Freys JC, Bigalke SM, Mertes M, Lobo DN, Pogatzki-Zahn EM, Freys SM; The 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.
citation: 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.
citation: 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.