- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06808087
Management of Acute Appendicitis Pain in the Emergency Department
Comparison of the Efficacy of Transversus Abdominis Plane Block and Erector Spinae Plane Block in the Management of Acute Appendicitis Pain in the Emergency Department
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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. 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 ESPB-50 group. Patients' pain levels will be assessed using the Numeric Rating Scale (NRS) at baseline. Subsequently, patients in the T-50 group will receive a 100 cc isotonic 0.9% NaCl (sodium chloride) solution containing 50 mg tramadol as an intravenous infusion over 15 minutes at baseline. 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. The steps for performing the TAP block are as follows:
Patient monitoring, preparation of the skin with 10% povidone-iodine and ensuring appropriate draping, 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. 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. Visualization of the oval spread of bupivacaine in the TAP.
Patients in the ESPB-50 group will receive a 100 cc isotonic 0.9% NaCl solution containing 50 mg tramadol as an intravenous infusion over 15 minutes at baseline, followed by an ESPB. The steps for performing the ESPB are as follows:
Patient monitoring, positioning the patient in the prone position, preparation of the skin with 10% povidone-iodine and ensuring appropriate draping, counting the transverse processes from the sacrum, placing a low-frequency curvilinear transducer parasagittally, and identifying the tip of the right transverse process at this level. Visualizing the erector spinae muscle overlying the transverse process. Inserting a 22 Gauge, 80 mm needle between the transverse process and the fascia of the erector spinae muscle. Injecting 1 to 3 milliliter (mL) of saline to confirm the separation of the erector spinae muscle fascia from the transverse process after negative aspiration, 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. Visualizing the oval spread of bupivacaine over the erector spinae muscle.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey (Türkiye)
- Ankara City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years and older
- Patients who provide written consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
50 mg of tramadol will be administered via IV infusion over 15 minutes in 100 cc of isotonic 0.9% NaCl (normal saline).
|
|
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.
|
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
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.
|
50 mg of tramadol will be administered via IV infusion over 15 minutes in 100 cc of isotonic 0.9% NaCl (normal saline).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Outcome
Time Frame: 1 year after study start date
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary Outcome
Time Frame: 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.
|
1 year after study start date
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmet Burak Erdem, Ankara Etlik City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Pathologic Processes
- Disease Attributes
- Intestinal Diseases
- Infections
- Digestive System Diseases
- Gastrointestinal Diseases
- Neurobehavioral Manifestations
- Gastroenteritis
- Perceptual Disorders
- Cecal Diseases
- Intraabdominal Infections
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Emergencies
- Agnosia
- Appendicitis
- Organic Chemicals
- Lipids
- Amines
- Alcohols
- Cyclohexanols
- Hexanols
- Fatty Alcohols
- Dimethylamines
- Methylamines
- Tramadol
Other Study ID Numbers
- AEŞH-EK1-2024-0037
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Appendicitis
-
North Estonia Medical CentreTartu University HospitalRecruitingAcute Appendicitis | Appendicitis Acute | Appendicitis Perforated | Acute Appendicitis With Rupture | Appendicitis; Perforation | Acute Appendicitis Without Peritonitis | Acute Appendicitis With Appendix AbscessEstonia
-
Kahramanmaras Sutcu Imam UniversityElazıg Fethi Sekin Sehir HastanesiCompletedThe Role of Preoperative HALP Score in Differentiating Complicated Acute Appendicitis (Appendicitis)Acute Appendicitis | Acute Appendicitis With Rupture | Acute Appendicitis Without Peritonitis | Acute Appendicitis With Appendix AbscessTurkey
-
University College, LondonCompletedAcute Appendicitis | Acute Appendicitis With RuptureUnited Kingdom
-
Pirogov Russian National Research Medical UniversityCompletedAcute Appendicitis | Acute Appendicitis With Rupture | Acute Appendicitis Without Peritonitis | Acute Appendicitis With PeritonitisRussian Federation
-
University Hospital, ToulouseNot yet recruitingAcute Uncomplicated AppendicitisFrance
-
Cedars-Sinai Medical CenterRecruitingAppendicitis Acute | Appendicitis Perforated | Appendicitis With Perforation | Appendicitis Suppurative | Appendicitis GangrenousUnited States
-
Fundación Pública Andaluza para la gestión de la...RecruitingAppendicitis Acute | Gangrenous AppendicitisSpain
-
Turku University HospitalOulu University Hospital; Kuopio University Hospital; Seinajoki Central Hospital and other collaboratorsNot yet recruitingUncomplicated Acute AppendicitisFinland
-
Hospital Universitario Virgen de la ArrixacaUnknownUncomplicated Acute AppendicitisSpain
-
HJ23Hospital Universitari Joan XXIII de Tarragona.Not yet recruitingAcute Appendicitis | Appendicitis Perforated | Appendicitis Suppurative
Clinical Trials on Tramadol
-
Queen Elizabeth Hospital, Hong KongCompleted
-
Federal Teaching Hospital AbakalikiCompletedLabour DurationNigeria
-
CrystalGenomics, Inc.Completed
-
Menarini GroupCompletedAcute PainRomania, Poland, Hungary, Latvia, Lithuania, Russian Federation, Slovakia, Spain
-
Par Pharmaceutical, Inc.AAI ClinicCompletedTo Determine Bioequivalence Under Fed Conditions
-
Tokat Gaziosmanpasa UniversityCompletedPain, Postoperative | PregnancyTurkey
-
Medical University of WarsawCompletedPain, Acute | Foot FracturePoland
-
Janssen Pharmaceutical K.K.CompletedPain | Postoperative PainJapan