Nerve BlockNCT06246292
The Efficacy and Safety of Landmark-guided Compared to Ultrasound-guided Erector Spinae Plane Block Techniques for Analgesia in Female Patients After Breast Surgery.
A study testing Ultrasound-guided ESPB and Anatomical landmark-guided ESPB in people with Nerve Block, run by Alexandria University at 1 site in Egypt.
Trial summary
The erector spinae plane (ESP) block is a technique that helps alleviate acute pain. It involves injecting local anesthetic between the erector spinae muscle (ESM) and the vertebra's transverse process (TP). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nerve Block
- What is being tested?
- Ultrasound-guided ESPB and Anatomical landmark-guided ESPB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2024to 1 Jul 2024
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older.
- Patients had an American Society of Anesthesiology (ASA) physical score of I-II.
- Patients undergoing unilateral elective breast surgery.
Who cannot join
- Patients had a contraindication to an ESPB (including coagulopathy, recent anticoagulant medication usage, or infection at the needle puncture site).
- Patients had a history of opioid addiction, preoperative opioid use, and allergies to study medications.
- Obesity (body mass index exceeding 35 kg/m²).
- If the placement of ESPB was not completed due to technique difficulties.
- Patients who expressed a lack of willingness to participate in the study were not considered eligible for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block: Anatomical Landmark Versus Ultra-sounded Guided Technique, a Randomized Controlled Trial
The erector spinae plane (ESP) block is a technique that helps alleviate acute pain. It involves injecting local anesthetic between the erector spinae muscle (ESM) and the vertebra's transverse process (TP). This technique can be guided by ultrasound or anatomical landmarks, and it can be performed while the patient is lying down, sitting or on their side.
Read the detailed description
Ultrasound guidance has established itself as the norm for regional anesthesia procedures, enabling live visualization of anatomical structures and enhancing the precision and safety of needle insertion. Conversely, the blind technique relies on anatomical landmarks and the ability to palpate to direct needle insertion. Although the blind technique might provide simplicity and efficiency, uncertainties persist concerning its precision and possible associated risks. As the popularity of the ESPB increases, a relevant query emerges: Should it be conducted with ultrasound guidance or through a non-guided technique? This study was designed to validate the efficacy and safety of a landmark-guided ESPB technique compared to an ultrasound-guided ESPB technique for analgesia in breast surgery. The hypothesis was that the ultrasound and anatomical landmark techniques for ESPB would provide equivalent analgesia. The study's primary objective was to compare the success rate of both techniques. The secondary objectives were to compare the dermatomal block spread, analgesic effectiveness, and technique-related complications.
- Conditions
- Nerve Block
- Being tested
- Ultrasound-guided ESPB, Anatomical landmark-guided ESPB
- Keywords
- Nerve block, breast surgery, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided ESPBProcedure or surgery
The ESPB is a truncal block guided by ultrasound, involving the injection of local anesthetic beneath the erector spinae muscle (ESM), positioned between the ESM and the transverse process (TP) of the vertebra.
Anatomical landmark-guided ESPBProcedure or surgery
The ESPB is a truncal block guided by anatomical landmarks, involving the injection of local anesthetic beneath the erector spinae muscle (ESM), positioned between the ESM and the transverse process (TP) of the vertebra.
| Study group | Role | What they receive |
|---|---|---|
| landmark guided ESPB technique | Experimental | The ESPB was performed using the landmarks described by Vadera et al. (5). Before initiating the block procedure, the spinous process of the T4 vertebra and a point situated 3 cm to its side are marked at the appropriate level. The needle was inserted perpendicularly to the skin and advanced in all planes until it contacts the vertebra's transverse process. The depth at which the thoracic vertebra's transverse process lies from the skin can vary, ranging from 2 to 4 cm, contingent upon the individual's physique. The needle tip was positioned between the erector spinae muscle and the transverse process. The volume of local anesthetics was injected in this plane. Receives: Procedure: Anatomical landmark-guided ESPB |
| ultrasound-guided ESPB technique | Active comparator | The block was performed based on the original description by Forero et al. (2). A high-frequency linear transducer (MyLab 70 Xvision, Esaote SpA, Florence, Italy) was positioned in the parasagittal plane 2 cm lateral to the T4 vertebra. Once the transverse process and the overlying erector spinae muscle were visible on the ultrasound, the needle was introduced using the in-plane technique. The needle was inserted in the cranial-to-caudal direction until it reached the tip of the transverse process. Following a negative aspiration and a successful hydro dissection, the local anesthetic solution was injected beneath the erector spinae muscle's fascia. Receives: Procedure: Ultrasound-guided ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the success rate of both landmark-guided ESPB and ultrasound-guided ESPB techniques for analgesia in breast surgery
The primary outcome was the binary outcome: therapeutic success or failure of ESPB techniques in achieving cutaneous sensory block for breast surgery (from T1 to T6).
Measured: 30 minutes after regional block procedure
Secondary outcomes (5)
To compare the dermatomal block spread in both groups
Assessment of the number of blocked cutaneous sensory dermatomes from T1 to T10.
Measured: 30 minutes after regional block procedure.
To compare the analgesic effectiveness in both groups
Assessment of rest visual analog score (VAS) for surgical site pain (0 -10) 2.
Measured: The first 24 hours postoperatively at 1, 3, 6, 12, and 24 hours.
To compare the technique-related complications in both groups
Assessment of occurrence of adverse effects.
Measured: During the regional block procedure.
To compare the analgesic effectiveness in both groups
The time (minutes) to the first intravenous patient-controlled analgesia (IV-PCA) demand dose.
Measured: The first 24 hours postoperatively.
To compare the analgesic effectiveness in both groups
Total fentanyl opioid consumption (microgram).
Measured: intra- and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start10 Feb 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Islam elbardan, Dr., Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246292
- Sponsor's protocol ID
- IRB number: 00012098
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2024
- Last updated
- 30 Jul 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block: Anatomical Landmark Versus Ultra-sounded Guided Technique, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06246292
- Acronym / sponsor ID
- IRB number: 00012098
- Conditions
- Nerve Block
- Keywords
- Nerve block, breast surgery, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 7 Feb 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.
The erector spinae plane (ESP) block is a technique that helps alleviate acute pain. It involves injecting local anesthetic between the erector spinae muscle (ESM) and the vertebra's transverse process (TP). This technique can be guided by ultrasound or anatomical landmarks, and it can be performed while the patient is lying down, sitting or on their side.
Detailed description
Ultrasound guidance has established itself as the norm for regional anesthesia procedures, enabling live visualization of anatomical structures and enhancing the precision and safety of needle insertion. Conversely, the blind technique relies on anatomical landmarks and the ability to palpate to direct needle insertion. Although the blind technique might provide simplicity and efficiency, uncertainties persist concerning its precision and possible associated risks. As the popularity of the ESPB increases, a relevant query emerges: Should it be conducted with ultrasound guidance or through a non-guided technique? This study was designed to validate the efficacy and safety of a landmark-guided ESPB technique compared to an ultrasound-guided ESPB technique for analgesia in breast surgery. The hypothesis was that the ultrasound and anatomical landmark techniques for ESPB would provide equivalent analgesia. The study's primary objective was to compare the success rate of both techniques. The secondary objectives were to compare the dermatomal block spread, analgesic effectiveness, and technique-related complications.
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 |
|---|---|---|
| landmark guided ESPB technique | Experimental | Procedure: Anatomical landmark-guided ESPBThe ESPB was performed using the landmarks described by Vadera et al. (5). Before initiating the block procedure, the spinous process of the T4 vertebra and a point situated 3 cm to its side are marked at the appropriate level. The needle was inserted perpendicularly to the skin and advanced in all planes until it contacts the vertebra's transverse process. The depth at which the thoracic vertebra's transverse process lies from the skin can vary, ranging from 2 to 4 cm, contingent upon the individual's physique. The needle tip was positioned between the erector spinae muscle and the transverse process. The volume of local anesthetics was injected in this plane. |
| ultrasound-guided ESPB technique | Active comparator | Procedure: Ultrasound-guided ESPBThe block was performed based on the original description by Forero et al. (2). A high-frequency linear transducer (MyLab 70 Xvision, Esaote SpA, Florence, Italy) was positioned in the parasagittal plane 2 cm lateral to the T4 vertebra. Once the transverse process and the overlying erector spinae muscle were visible on the ultrasound, the needle was introduced using the in-plane technique. The needle was inserted in the cranial-to-caudal direction until it reached the tip of the transverse process. Following a negative aspiration and a successful hydro dissection, the local anesthetic solution was injected beneath the erector spinae muscle's fascia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or older.
- Patients had an American Society of Anesthesiology (ASA) physical score of I-II.
- Patients undergoing unilateral elective breast surgery.
Key exclusion criteria (5 listed)
- Patients had a contraindication to an ESPB (including coagulopathy, recent anticoagulant medication usage, or infection at the needle puncture site).
- Patients had a history of opioid addiction, preoperative opioid use, and allergies to study medications.
- Obesity (body mass index exceeding 35 kg/m²).
- If the placement of ESPB was not completed due to technique difficulties.
- Patients who expressed a lack of willingness to participate in the study were not considered eligible for participation.
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 |
|---|---|---|
| Ultrasound-guided ESPBThe ESPB is a truncal block guided by ultrasound, involving the injection of local anesthetic beneath the erector spinae muscle (ESM), positioned between the ESM and the transverse process (TP) of the vertebra. | Procedure or surgery | ultrasound-guided ESPB technique |
| Anatomical landmark-guided ESPBThe ESPB is a truncal block guided by anatomical landmarks, involving the injection of local anesthetic beneath the erector spinae muscle (ESM), positioned between the ESM and the transverse process (TP) of the vertebra. | Procedure or surgery | landmark guided ESPB technique |
Primary outcome
To compare the success rate of both landmark-guided ESPB and ultrasound-guided ESPB techniques for analgesia in breast surgery
Time frame: 30 minutes after regional block procedure
The primary outcome was the binary outcome: therapeutic success or failure of ESPB techniques in achieving cutaneous sensory block for breast surgery (from T1 to T6).
5 secondary outcomes
To compare the dermatomal block spread in both groups
Time frame: 30 minutes after regional block procedure.
To compare the analgesic effectiveness in both groups
Time frame: The first 24 hours postoperatively at 1, 3, 6, 12, and 24 hours.
To compare the technique-related complications in both groups
Time frame: During the regional block procedure.
To compare the analgesic effectiveness in both groups
Time frame: The first 24 hours postoperatively.
To compare the analgesic effectiveness in both groups
Time frame: intra- and 24 hours postoperatively
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 30 Jul 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. This study is not recruiting at the moment.
Islam elbardan, Dr. principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided ESPB and Anatomical landmark-guided ESPB in people with Nerve Block, run by Alexandria University at 1 site in Egypt.
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 3 inclusion and 5 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 30 Jul 2024. 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 Egypt. 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?
To compare the success rate of both landmark-guided ESPB and ultrasound-guided ESPB techniques for analgesia in breast surgery (time frame: 30 minutes after regional block procedure). 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 30 Jul 2024.