Management of Acute Appendicitis Pain in the Emergency Department

NCT06808087 | Completed

• 1 other identifier: AEŞH-EK1-2024-0037
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effectiveness of TAP (Transversus Abdominal Plane) block, ESPB (Erector Spinal Plane Block), and tramadol in preoperative pain management for patients diagnosed with acute appendicitis and undergoing emergency surgery in the emergency department. The study will evaluate the potential of TAP block and ESPB administered to patients diagnosed with acute appendicitis in the emergency department to reduce pain intensity before surgical intervention. This study aims to contribute to practical applications to ensure optimal pain control for acute appendicitis patients under emergency department conditions.

Conditions

Acute Appendicitis

Keywords

Transversus Abdominis Plane Block; Erector Spinae Plane Block; Acute Appendicitis; Pain Management; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Determination of whether TAP-ESP block reduces the need for opioids in the management of acute appendicitis pain in the emergency department.

  1 year after study start date

Secondary Outcomes (1)

• Secondary Outcome

  1 year after study start date

Study Arms (3)

T-50

Patients 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.

Drug: Tramadol

TAP-50

Patients in the TAP-50 group will receive the same intravenous tramadol infusion as the T-50 group at baseline, followed by a TAP block.

Procedure: Transversus abdominis plane blockage; Drug: Tramadol

ESPB-50

Patients in the ESPB-50 group will receive the same intravenous tramadol infusion as the T-50 group at baseline, followed by an ESP block.

Procedure: Erector spinae plane blockage; Drug: Tramadol

Interventions

Erector spinae plane blockage PROCEDURE

1. Patient monitoring 2. Positioning the patient in the prone position 3. Preparation of the skin with 10% povidone-iodine and ensuring appropriate draping 4. Counting the transverse processes from the sacrum to find the L1 level 5. Placing a low-frequency curvilinear transducer (depth set to 3-5 cm) parasagittally, and identifying the tip of the right transverse process at this level 6. Visualizing the erector spinae muscle overlying the transverse process 7. Inserting a 22G, 80 mm needle between the transverse process and the fascia of the erector spinae muscle 8. Injecting 1 to 3 mL of saline to confirm the separation of the erector spinae muscle fascia from the transverse process after negative aspiration 9. Injecting 20 mL of 0.25% bupivacaine, prepared by diluting 10 mL of 0.5% bupivacaine with 10 mL of normal saline, after another negative aspiration 10. Visualizing the oval spread of bupivacaine over the erector spinae muscle.

ESPB-50

Transversus abdominis plane blockage PROCEDURE

1. Patient monitoring 2. Preparation of the skin with 10% povidone-iodine and ensuring appropriate draping 3. Placement of a high-frequency linear transducer 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. 4. 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. 5. 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. 6. Visualization of the oval spread of bupivacaine in the TAP.

TAP-50

Tramadol DRUG

50 mg of tramadol will be administered via IV infusion over 15 minutes in 100 cc of isotonic 0.9% NaCl (normal saline).

ESPB-50; T-50; TAP-50

Eligibility Criteria

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

Study Population

From the date of ethics committee approval, patients diagnosed with acute appendicitis in the emergency department and determined to undergo definitive surgery following general surgical consultation: patients with suspected acute appendicitis based on history, physical examination, laboratory tests, and Alvarado score calculation, and confirmed by ultrasound (USG) and/or contrast/non-contrast abdominal CT scans.

You may qualify if:

• Patients aged 18 years and older
• Patients who provide written consent

You may not qualify if:

• Patients with abdominal wall anatomical abnormalities
• Patients with known local anesthetic allergies
• Patients with a BMI \>30
• Patients weighing less than 45 kg
• Patients with coagulopathy
• Patients with opioid, alcohol, or substance dependence
• Patients with skin infections at the site of local anesthetic administration
• Pregnant or breastfeeding patients
• Hemodynamically unstable patients
• Patients with liver or kidney failure
• Patients with chronic pain conditions
• 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

MeSH Terms

Conditions

Appendicitis; Agnosia; Emergencies

Interventions

Tramadol

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

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Ahmet Burak Erdem

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: May 8, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

TU (1)