Opioid ConsumptionNCT06742177
Comparison of Bi-Level Erector Spinae Plane Block (ESPB) and Modified Thoraco Abdominal Plane Block (M-TAPA)
A study testing Group Bi-level ESPB and Group M-TAPA block in people with Opioid Consumption and Numerical Rating Scale, run by Ankara Etlik City Hospital.
Trial summary
Laparoscopy is a surgical technique used for basic diagnosis and treatment. The advantages of laparoscopic techniques compared to open surgery have been demonstrated by studies. With the developing medicine and technology, minimally invasive approaches have been targeted in interventional procedures. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Opioid Consumption, Numerical Rating Scale, Demographic Data
- What is being tested?
- Group Bi-level ESPB and Group M-TAPA block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1-Patients over 18 years of age
- 2.Those with ASA score I-II-III
- 3.Those with body mass index (BMI) between 18-40
- 4.Patients who underwent LAS in the operating room with Bi-level ESPB or M-TAPA
Who cannot join
- Those under 18 years of age
- Those with ASA score IV and above
- Those with advanced co-morbidities
- Those with a history of bleeding diathesis
- Patients with infection in the area where the block will be performed
- Those with BMI below 18 and above 40
- Patients who underwent surgery under emergency conditions
- 8- Patients with advanced liver and kidney failure
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Bi-Level Erector Spinae Plane Block (ESPB) and Modified Thoraco Abdominal Plane Block (M-TAPA) in Laparoscopic Abdominal Surgery
Laparoscopy is a surgical technique used for basic diagnosis and treatment. The advantages of laparoscopic techniques compared to open surgery have been demonstrated by studies. With the developing medicine and technology, minimally invasive approaches have been targeted in interventional procedures. In laparoscopic surgeries, access to the abdomen is provided with the help of a trocar and a temporary pneumoperitoneum is created with gas insufflation. Despite all these developments, even when laparoscopic techniques are used, postoperative pain is the most disturbing issue for patients. Postoperative pain can seriously reduce the quality of life in patients and acute pain can even trigger chronic pain syndromes. Epidural analgesia, paravertebral, erector spinae plane, intercostal nerve, transverse abdominis plane, external oblique, modified thoracoabdominal plane, rectus sheath block are used for anesthesia and analgesia during laparoscopic abdominal surgeries (LAS). In recent years, regional nerve blocks, including erector spinae plane block (ESPB) and modified thoraco-abdominal plane block (M-TAPA), have been applied for the treatment of pain in patients undergoing LAS due to various causes. ESPB was first described by Forero et al. in 2016 and has been frequently used for the treatment of acute pain in the postoperative period following abdominal surgeries. ESPB can be applied at any level from cervical to sacral, covering dermatomes appropriate for the surgical area under USG guidance. Cadaver studies for the ESPB mechanism have shown that local anesthetic spreads ipsilaterally and contralaterally and that it has analgesic efficacy both on the side where it is applied and on the opposite side. This peripheral nerve block, which is usually applied at a single level, can also be applied at bi-level. Studies have also shown that when ESPB is applied at bi-level, analgesic efficacy increases due to local anesthetic spread.
M-TAPA is a new peripheral nerve block technique defined by Tulgar et al. It has high analgesic efficacy in thoraco-abdominal surgery. It has been shown to be advantageous in upper umbilical surgeries by involving more dermatomes compared to the transverse abdominis plane block. Lateral and anterior branches of thoraco-abdominal nerves are blocked with M-TAPA. It provides analgesia in a wide area between T5 and T12 and can also be applied for LAS. In our clinic, Bi-level ESPB or M-TAPA is routinely applied to suitable patients after anesthesia induction, and intraoperative anesthesia is maintained with inhalation and intravenous anesthetic agents. Multimodal analgesia management has been adopted as postoperative analgesia management.
- Conditions
- Opioid Consumption, Numerical Rating Scale, Demographic Data
- Being tested
- Group Bi-level ESPB, Group M-TAPA block
- Keywords
- Modified Thoraco Abdominal Block, Erector Spinae Plane Block, Abdominal surgery, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Bi-level ESPBProcedure or surgery
The block procedure is performed immediately before surgery begins after general anesthesia induction, with the patient in the lateral decubitus position. For the block, sterile conditions are provided with USG, and the erector spinae muscle and vertebral process are visualized, and the in plane technique is used. The target vertebral level for bi-level ESPB is two levels, T5 and T7. The block needle is advanced in the caudo-cranial direction, and the potential area between the erector spinae muscle and the transverse process of the relevant vertebra is targeted. The block location is confirmed by injecting 2 ml of saline between the transverse process and the muscle. After the block location is confirmed, a total of 40 ml of 0.25% bupivacaine is applied, using 20 ml of 0.25% bupivacaine for a single level.
Group M-TAPA blockProcedure or surgery
The procedure is performed in the supine position immediately before surgery after general anesthesia induction and the in plane technique is used. The transversus abdominis, internal oblique and external oblique muscles are identified at the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal margin. The block needle is advanced in the caudo-cranial direction and a deep angle is given with the probe in the sagittal direction to the costochondral angle at the edge of the 10th rib to visualize the lower surface of the costal cartilage in the midline. The block location is confirmed by injecting 2 ml of saline onto the transverse abdominis muscle under the 10th costal cartilage. After the block location is confirmed, 20 ml of 0.25% bupivacaine is used. This procedure is repeated for the opposite side and a total of 40 ml of 0.25% bupivacaine is used.
| Study group | Role | What they receive |
|---|---|---|
| Group Bi-level ESPB | Active comparator | The block procedure is performed immediately before surgery begins after general anesthesia induction, with the patient in the lateral decubitus position. For the block, sterile conditions are provided with USG, and the erector spinae muscle and vertebral process are visualized, and the in plane technique is used. The target vertebral level for bi-level ESPB is two levels, T5 and T7. The block needle is advanced in the caudo-cranial direction, and the potential area between the erector spinae muscle and the transverse process of the relevant vertebra is targeted. The block location is confirmed by injecting 2 ml of saline between the transverse process and the muscle. After the block location is confirmed, a total of 40 ml of 0.25% bupivacaine is applied, using 20 ml of 0.25% bupivacaine for a single level. Receives: Procedure: Group Bi-level ESPB |
| Group M-TAPA Block | Active comparator | The procedure is performed in the supine position immediately before surgery after general anesthesia induction and the in plane technique is used. The transversus abdominis, internal oblique and external oblique muscles are identified at the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal margin. The block needle is advanced in the caudo-cranial direction and a deep angle is given with the probe in the sagittal direction to the costochondral angle at the edge of the 10th rib to visualize the lower surface of the costal cartilage in the midline. The block location is confirmed by injecting 2 ml of saline onto the transverse abdominis muscle under the 10th costal cartilage. After the block location is confirmed, 20 ml of 0.25% bupivacaine is used. This procedure is repeated for the opposite side and a total of 40 ml of 0.25% bupivacaine is used. Receives: Procedure: Group M-TAPA block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative opioid consumption.
Intraoperative opioid consumption will be recorded.
Measured: Intraoperative period
Secondary outcomes (1)
Pain Scores
Pain will be assessed using a numerical rating scale from 0 (no pain) to 10 (worst pain) at rest and during coughing. Pain assessment will be made at 1, 2, 6, 12, and 24 hours after surgery. The numerical rating scale is 10 (worst) severe, unbearable pain; 0 (best) no pain.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid ConsumptionStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seyyid Furkan Kına, Ankara Etlik City Hospital
- Investigators
- Seyyid Furkan Seyyid Furkan, MD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742177
- Sponsor's protocol ID
- AEŞH-EK1-2024-0067
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bi-Level Erector Spinae Plane Block (ESPB) and Modified Thoraco Abdominal Plane Block (M-TAPA) in Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06742177
- Acronym / sponsor ID
- AEŞH-EK1-2024-0067
- Conditions
- Opioid Consumption, Numerical Rating Scale, Demographic Data
- Keywords
- Modified Thoraco Abdominal Block, Erector Spinae Plane Block, Abdominal surgery, Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 19 Dec 2024 (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.
Laparoscopy is a surgical technique used for basic diagnosis and treatment. The advantages of laparoscopic techniques compared to open surgery have been demonstrated by studies. With the developing medicine and technology, minimally invasive approaches have been targeted in interventional procedures. In laparoscopic surgeries, access to the abdomen is provided with the help of a trocar and a temporary pneumoperitoneum is created with gas insufflation. Despite all these developments, even when laparoscopic techniques are used, postoperative pain is the most disturbing issue for patients. Postoperative pain can seriously reduce the quality of life in patients and acute pain can even trigger chronic pain syndromes. Epidural analgesia, paravertebral, erector spinae plane, intercostal nerve, transverse abdominis plane, external oblique, modified thoracoabdominal plane, rectus sheath block are used for anesthesia and analgesia during laparoscopic abdominal surgeries (LAS). In recent years, regional nerve blocks, including erector spinae plane block (ESPB) and modified thoraco-abdominal plane block (M-TAPA), have been applied for the treatment of pain in patients undergoing LAS due to various causes. ESPB was first described by Forero et al. in 2016 and has been frequently used for the treatment of acute pain in the postoperative period following abdominal surgeries. ESPB can be applied at any level from cervical to sacral, covering dermatomes appropriate for the surgical area under USG guidance. Cadaver studies for the ESPB mechanism have shown that local anesthetic spreads ipsilaterally and contralaterally and that it has analgesic efficacy both on the side where it is applied and on the opposite side. This peripheral nerve block, which is usually applied at a single level, can also be applied at bi-level. Studies have also shown that when ESPB is applied at bi-level, analgesic efficacy increases due to local anesthetic spread.
M-TAPA is a new peripheral nerve block technique defined by Tulgar et al. It has high analgesic efficacy in thoraco-abdominal surgery. It has been shown to be advantageous in upper umbilical surgeries by involving more dermatomes compared to the transverse abdominis plane block. Lateral and anterior branches of thoraco-abdominal nerves are blocked with M-TAPA. It provides analgesia in a wide area between T5 and T12 and can also be applied for LAS. In our clinic, Bi-level ESPB or M-TAPA is routinely applied to suitable patients after anesthesia induction, and intraoperative anesthesia is maintained with inhalation and intravenous anesthetic agents. Multimodal analgesia management has been adopted as postoperative analgesia management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Bi-level ESPB | Active comparator | Procedure: Group Bi-level ESPBThe block procedure is performed immediately before surgery begins after general anesthesia induction, with the patient in the lateral decubitus position. For the block, sterile conditions are provided with USG, and the erector spinae muscle and vertebral process are visualized, and the in plane technique is used. The target vertebral level for bi-level ESPB is two levels, T5 and T7. The block needle is advanced in the caudo-cranial direction, and the potential area between the erector spinae muscle and the transverse process of the relevant vertebra is targeted. The block location is confirmed by injecting 2 ml of saline between the transverse process and the muscle. After the block location is confirmed, a total of 40 ml of 0.25% bupivacaine is applied, using 20 ml of 0.25% bupivacaine for a single level. |
| Group M-TAPA Block | Active comparator | Procedure: Group M-TAPA blockThe procedure is performed in the supine position immediately before surgery after general anesthesia induction and the in plane technique is used. The transversus abdominis, internal oblique and external oblique muscles are identified at the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal margin. The block needle is advanced in the caudo-cranial direction and a deep angle is given with the probe in the sagittal direction to the costochondral angle at the edge of the 10th rib to visualize the lower surface of the costal cartilage in the midline. The block location is confirmed by injecting 2 ml of saline onto the transverse abdominis muscle under the 10th costal cartilage. After the block location is confirmed, 20 ml of 0.25% bupivacaine is used. This procedure is repeated for the opposite side and a total of 40 ml of 0.25% bupivacaine is used. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1-Patients over 18 years of age
- 2.Those with ASA score I-II-III
- 3.Those with body mass index (BMI) between 18-40
- 4.Patients who underwent LAS in the operating room with Bi-level ESPB or M-TAPA
Key exclusion criteria (8 listed)
- Those under 18 years of age
- Those with ASA score IV and above
- Those with advanced co-morbidities
- Those with a history of bleeding diathesis
- Patients with infection in the area where the block will be performed
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 |
|---|---|---|
| Group Bi-level ESPBThe block procedure is performed immediately before surgery begins after general anesthesia induction, with the patient in the lateral decubitus position. For the block, sterile conditions are provided with USG, and the erector spinae muscle and vertebral process are visualized, and the in plane technique is used. The target vertebral level for bi-level ESPB is two levels, T5 and T7. The block needle is advanced in the caudo-cranial direction, and the potential area between the erector spinae muscle and the transverse process of the relevant vertebra is targeted. The block location is confirmed by injecting 2 ml of saline between the transverse process and the muscle. After the block location is confirmed, a total of 40 ml of 0.25% bupivacaine is applied, using 20 ml of 0.25% bupivacaine for a single level. | Procedure or surgery | Group Bi-level ESPB |
| Group M-TAPA blockThe procedure is performed in the supine position immediately before surgery after general anesthesia induction and the in plane technique is used. The transversus abdominis, internal oblique and external oblique muscles are identified at the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal margin. The block needle is advanced in the caudo-cranial direction and a deep angle is given with the probe in the sagittal direction to the costochondral angle at the edge of the 10th rib to visualize the lower surface of the costal cartilage in the midline. The block location is confirmed by injecting 2 ml of saline onto the transverse abdominis muscle under the 10th costal cartilage. After the block location is confirmed, 20 ml of 0.25% bupivacaine is used. This procedure is repeated for the opposite side and a total of 40 ml of 0.25% bupivacaine is used. | Procedure or surgery | Group M-TAPA Block |
Primary outcome
Intraoperative opioid consumption.
Time frame: Intraoperative period
Intraoperative opioid consumption will be recorded.
1 secondary outcome
Pain Scores
Time frame: 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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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.
Seyyid Furkan Seyyid Furkan, MD principal investigator
Ankara Etlik City Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Group Bi-level ESPB and Group M-TAPA block in people with Opioid Consumption and Numerical Rating Scale, run by Ankara Etlik City Hospital.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seyyid Furkan Seyyid Furkan, MD (00905301539252, kinafurkan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative opioid consumption. (time frame: Intraoperative period). 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 19 Dec 2024.