LumbosacralNCT06580704
Lumbosacral Erector Spinae Plane Block Versus Psoas Muscle Compartment With Sciatic Nerve Block for Anesthesia for Unilateral Lower Limb Operations in Critically Ill Patients
A study testing Lumbosacral Erector Spinae Plane Block and Psoas Muscle Compartment With Sciatic Nerve Block in people with Lumbosacral and Erector Spinae Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare lumbosacral erector spinae plane block and psoas muscle compartment with sciatic nerve block in unilateral lower limb operations in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbosacral, Erector Spinae Plane Block, Psoas Muscle Compartment Block
- What is being tested?
- Lumbosacral Erector Spinae Plane Block and Psoas Muscle Compartment With Sciatic Nerve Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Aug 2024to 26 Mar 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of allergy to local anesthetics.
- Bleeding tendency.
- Coagulopathy.
- Anticoagulant therapy.
- Pre-existing psychological, neurologic, and spinal cord diseases.
- Previous back surgery.
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- Infection or mass at the site of the block.
- Chronic analgesic therapy.
- Severe cardiac or renal diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lumbosacral Erector Spinae Plane Block Versus Psoas Muscle Compartment With Sciatic Nerve Block for Anesthesia for Unilateral Lower Limb Operations in Critically Ill Patients: A Randomized Clinical Study
This study aims to compare lumbosacral erector spinae plane block and psoas muscle compartment with sciatic nerve block in unilateral lower limb operations in critically ill patients.
Read the detailed description
The lower limb surgeries are associated with acute postoperative pain and require long-term analgesia. Regional anesthesia is often used to prevent postoperative pain. Ultrasound-guided regional anesthetic approaches provide a simple intraoperative pathway that lowers pain scores with less impact on the respiratory or cardiovascular system.
Psoas compartment block (PCB) is a peripheral regional technique of anesthesia, which provides a block of the main components of the lumbar plexus - the femoral, lateral cutaneous nerve of the femur and sciatic nerve. In combination with the sciatic nerve block, the psoas compartment block provides effective anesthesia of the entire lower extremity, with better hemodynamic stability.
The erector Spinae plane block (ESPB) is a novel regional block technique primarily introduced in 2016 for managing severe neuropathic pain.
- Conditions
- Lumbosacral, Erector Spinae Plane Block, Psoas Muscle Compartment Block, Sciatic Nerve Block, Anesthesia, Unilateral
- Being tested
- Lumbosacral Erector Spinae Plane Block, Psoas Muscle Compartment With Sciatic Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbosacral Erector Spinae Plane BlockDrug
Patients will receive ultrasound-guided lumbosacral erector spinae plane block.
Psoas Muscle Compartment With Sciatic Nerve BlockDrug
Patients will receive ultrasound-guided psoas muscle compartment with sciatic nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Lumbosacral Erector Spinae Plane Block | Experimental | Patients will receive ultrasound-guided lumbosacral erector spinae plane block. Receives: Drug: Lumbosacral Erector Spinae Plane Block |
| Psoas Muscle Compartment With Sciatic Nerve Block | Experimental | Patients will receive ultrasound-guided psoas muscle compartment with sciatic nerve block. Receives: Drug: Psoas Muscle Compartment With Sciatic Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of failure
Incidence of failure will be recorded. After 30minutes, the pinprick test will be performed. If pain persists, the patient will be excluded.
Measured: Intraoperatively
Secondary outcomes (6)
Hear rate
Hear rate will be recorded preoperative, before performing of block, and every 15 minutes till the end of surgery.
Measured: Every 15 minutes till the end of surgery (up to 2 hours)
Mean arterial pressure
Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 minutes till the end of surgery.
Measured: Every 15 minutes till the end of surgery (up to 2 hours)
Duration of analgesia
Duration of analgesia (time from the injection of anesthetic solution to the first request of rescue analgesic drug) will be assessed.
Measured: Till the first request of rescue analgesic drug (up to 24 hours after surgery)
Degree of pain
Each patient will be instructed about postoperative pain assessment with the visual analogue scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at PACU, 2, 4, 6, 8, 12, and 24 h postoperatively.
Measured: 24 hours postoperatively
Degree of patient satisfaction
The degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, postoperative nausea and vomiting (PONV), hematoma, or any other complication will be recorded.
Measured: 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 posted30 Aug 2024
- Study start31 Aug 2024
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LumbosacralStudies of the same condition, open and under way.
- More trials run by Tanta 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
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580704
- Sponsor's protocol ID
- 36264PR761/7/24
- Status last verified
- Apr 2025
- First submitted
- 24 Aug 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbosacral Erector Spinae Plane Block Versus Psoas Muscle Compartment With Sciatic Nerve Block for Anesthesia for Unilateral Lower Limb Operations in Critically Ill Patients: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06580704
- Acronym / sponsor ID
- 36264PR761/7/24
- Conditions
- Lumbosacral, Erector Spinae Plane Block, Psoas Muscle Compartment Block, Sciatic Nerve Block, Anesthesia, Unilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 30 Aug 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.
This study aims to compare lumbosacral erector spinae plane block and psoas muscle compartment with sciatic nerve block in unilateral lower limb operations in critically ill patients.
Detailed description
The lower limb surgeries are associated with acute postoperative pain and require long-term analgesia. Regional anesthesia is often used to prevent postoperative pain. Ultrasound-guided regional anesthetic approaches provide a simple intraoperative pathway that lowers pain scores with less impact on the respiratory or cardiovascular system.
Psoas compartment block (PCB) is a peripheral regional technique of anesthesia, which provides a block of the main components of the lumbar plexus - the femoral, lateral cutaneous nerve of the femur and sciatic nerve. In combination with the sciatic nerve block, the psoas compartment block provides effective anesthesia of the entire lower extremity, with better hemodynamic stability.
The erector Spinae plane block (ESPB) is a novel regional block technique primarily introduced in 2016 for managing severe neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbosacral Erector Spinae Plane Block | Experimental | Drug: Lumbosacral Erector Spinae Plane BlockPatients will receive ultrasound-guided lumbosacral erector spinae plane block. |
| Psoas Muscle Compartment With Sciatic Nerve Block | Experimental | Drug: Psoas Muscle Compartment With Sciatic Nerve BlockPatients will receive ultrasound-guided psoas muscle compartment with sciatic nerve block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- History of allergy to local anesthetics.
- Bleeding tendency.
- Coagulopathy.
- Anticoagulant therapy.
- Pre-existing psychological, neurologic, and spinal cord diseases.
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 |
|---|---|---|
| Lumbosacral Erector Spinae Plane BlockPatients will receive ultrasound-guided lumbosacral erector spinae plane block. | Drug | Lumbosacral Erector Spinae Plane Block |
| Psoas Muscle Compartment With Sciatic Nerve BlockPatients will receive ultrasound-guided psoas muscle compartment with sciatic nerve block. | Drug | Psoas Muscle Compartment With Sciatic Nerve Block |
Primary outcome
Incidence of failure
Time frame: Intraoperatively
Incidence of failure will be recorded. After 30minutes, the pinprick test will be performed. If pain persists, the patient will be excluded.
6 secondary outcomes
Hear rate
Time frame: Every 15 minutes till the end of surgery (up to 2 hours)
Mean arterial pressure
Time frame: Every 15 minutes till the end of surgery (up to 2 hours)
Duration of analgesia
Time frame: Till the first request of rescue analgesic drug (up to 24 hours after surgery)
Degree of pain
Time frame: 24 hours postoperatively
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 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 15 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbosacral Erector Spinae Plane Block and Psoas Muscle Compartment With Sciatic Nerve Block in people with Lumbosacral and Erector Spinae Plane Block, run by Tanta 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 0 inclusion and 9 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 15 Apr 2025. 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?
Incidence of failure (time frame: Intraoperatively). 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 15 Apr 2025.