Acute AppendicitisNCT06808087
Management of Acute Appendicitis Pain in the Emergency Department
An observational study of Acute Appendicitis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Transversus abdominis plane blockage, Erector spinae plane blockage and Tramadol
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2024to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients aged 18 years and older
- Patients who provide written consent
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Acute Appendicitis
- Being tested
- Transversus abdominis plane blockage, Erector spinae plane blockage, Tramadol
- Keywords
- Transversus Abdominis Plane Block, Erector Spinae Plane Block, Acute Appendicitis, Pain Management, Emergency Department
- Medical subject headings
- Appendicitis, Agnosia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane blockageProcedure or surgery
- 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.
Erector spinae plane blockageProcedure or surgery
- 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 to find the L1 level
- 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
- Visualizing the erector spinae muscle overlying the transverse process
- Inserting a 22G, 80 mm needle between the transverse process and the fascia of the erector spinae muscle
- Injecting 1 to 3 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.
TramadolDrug
50 mg of tramadol will be administered via IV infusion over 15 minutes in 100 cc of isotonic 0.9% NaCl (normal saline).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Erector spinae plane blockage; Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Determination of whether TAP-ESP block reduces the need for opioids in the management of acute appendicitis pain in the emergency department.
Measured: 1 year after study start date
Secondary outcomes (1)
Secondary Outcome
Evaluation of the effectiveness of multimodal pain control for acute appendicitis pain in the emergency department across different groups.
Measured: 1 year after study start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start8 May 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmet Burak Erdem, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808087
- Sponsor's protocol ID
- AEŞH-EK1-2024-0037
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06808087
- Acronym / sponsor ID
- AEŞH-EK1-2024-0037
- Conditions
- Acute Appendicitis
- Keywords
- Transversus Abdominis Plane Block, Erector Spinae Plane Block, Acute Appendicitis, Pain Management, Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T-50 | – | Drug: TramadolPatients 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. |
| TAP-50 | – | Procedure: Transversus abdominis plane blockage, Drug: TramadolPatients in the TAP-50 group will receive the same intravenous tramadol infusion as the T-50 group at baseline, followed by a TAP block. |
| ESPB-50 | – | Procedure: Erector spinae plane blockage, Drug: TramadolPatients in the ESPB-50 group will receive the same intravenous tramadol infusion as the T-50 group at baseline, followed by an ESP block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients aged 18 years and older
- Patients who provide written consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus abdominis plane blockage1. 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. | Procedure or surgery | TAP-50 |
| Erector spinae plane blockage1. 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. | Procedure or surgery | ESPB-50 |
| Tramadol50 mg of tramadol will be administered via IV infusion over 15 minutes in 100 cc of isotonic 0.9% NaCl (normal saline). | Drug | ESPB-50, T-50, TAP-50 |
Primary outcome
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 secondary outcome
Secondary Outcome
Time frame: 1 year after study start date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Related trials for Acute Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Burak Erdem principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 1 year after study start date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.