Lumbar Erector Spinae Plane BlockNCT06573931
Lumbar Erector Spinae Plane Block vs Fascia Iliaca Block vs Lumbar Plexus Block for Postoperative Analgesia for Total Hip Arthroplasty
A study testing Lumbar Erector Spinae Plane Block, Fascia Iliaca Block and Lumbar Plexus Block in people with Lumbar Erector Spinae Plane Block and Fascia Iliaca Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare lumbar erector spinae plane block, fascia iliaca block, and lumbar plexus block for postoperative analgesia for hip surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Erector Spinae Plane Block, Fascia Iliaca Block, Lumbar Plexus Block
- What is being tested?
- Lumbar Erector Spinae Plane Block, Fascia Iliaca Block and Lumbar Plexus Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Aug 2024to 15 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Undergoing total hip arthroplasty under spinal anesthesia.
Who cannot join
- Obesity (Body Mass Index > 30 kg/m2).
- Allergy to any drug used in the study.
- Contraindications to spinal anesthesia (such as Thrombocytopenia (platelets <100,000/mCL) and coagulopathy (INR >1.4 or insufficient time since stopping systemic anticoagulation)).
- Epilepsy.
- Psychiatric disease.
- Pre-existing neurologic deficits or neuropathies.
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- Pregnancy.
- Pre-existing alcohol/opioid use disorder.
- Previously diagnosed with chronic pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lumbar Erector Spinae Plane Block vs Fascia Iliaca Block vs Lumbar Plexus Block for Postoperative Analgesia for Total Hip Arthroplasty: A Randomized Clinical Trial
This study aims to compare lumbar erector spinae plane block, fascia iliaca block, and lumbar plexus block for postoperative analgesia for hip surgery.
Read the detailed description
Approximately 500,000 hip arthroplasties are performed each year in the United States. Traditionally, this procedure has been performed under general anesthesia. However, neuraxial and regional anesthesia have become more commonly utilized to aid in postoperative analgesia and reduce the side effects of opioids, namely sedation, nausea, and vomiting. Postoperative pain control has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and overall patient satisfaction.
Lumbar erector spinae plane block (LESPB) was reported to lead to effective postoperative analgesia in hip and proximal femoral surgery.
The fascia iliaca block (FIB) is an established and effective technique, especially when US guidance and proximal approaches are used.
lumbar plexus block (LPB) could be safe because of the targeted somatic nerve block in the psoas region which prevents dispensable sympathetic block even in cardiovascular-compromised patients.
- Conditions
- Lumbar Erector Spinae Plane Block, Fascia Iliaca Block, Lumbar Plexus Block, Analgesia, Total Hip Arthroplasty
- Being tested
- Lumbar Erector Spinae Plane Block, Fascia Iliaca Block, Lumbar Plexus Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Erector Spinae Plane BlockOther
Patients will receive lumbar erector spinae plane block at the end of surgery.
Fascia Iliaca BlockOther
Patients will receive fascia iliaca block at the end of surgery.
Lumbar Plexus BlockOther
Patients will receive lumbar plexus block at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Erector Spinae Plane Block | Experimental | Patients will receive lumbar erector spinae plane block at the end of surgery. Receives: Other: Lumbar Erector Spinae Plane Block |
| Fascia Iliaca Block | Experimental | Patients will receive fascia iliaca block at the end of surgery. Receives: Other: Fascia Iliaca Block |
| Lumbar Plexus Block | Experimental | Patients will receive lumbar plexus block at the end of surgery. Receives: Other: Lumbar Plexus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia (time from end of block to first dose of morphine administrated) will be recorded.
Measured: 24 hours postoperatively
Secondary outcomes (3)
Total morphine consumption in the 1st 24h
Rescue analgesia will be provided by patient-controlled analgesia (PCA) with intravenous morphine (no basal rate; bolus 1 mg, lockout 10 minutes, maximum dose 20 mg in 4 h), which will be started if the numeric rating scale (NRS)> 3. NRS will be assessed at PACU, 4, 8, 16, and 24 h postoperatively.
Measured: 24 hours postoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at PACU, 4, 8, 16, and 24 h postoperatively.
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as Bradycardia, hypotension, postoperative nausea and vomiting (PONV), 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 posted27 Aug 2024
- Study start29 Aug 2024
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Erector Spinae Plane BlockStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 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
- NCT06573931
- Sponsor's protocol ID
- 36264PR760/7/24
- Status last verified
- Apr 2025
- First submitted
- 24 Aug 2024
- Last updated
- 18 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Erector Spinae Plane Block vs Fascia Iliaca Block vs Lumbar Plexus Block for Postoperative Analgesia for Total Hip Arthroplasty: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06573931
- Acronym / sponsor ID
- 36264PR760/7/24
- Conditions
- Lumbar Erector Spinae Plane Block, Fascia Iliaca Block, Lumbar Plexus Block, Analgesia, Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 27 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 lumbar erector spinae plane block, fascia iliaca block, and lumbar plexus block for postoperative analgesia for hip surgery.
Detailed description
Approximately 500,000 hip arthroplasties are performed each year in the United States. Traditionally, this procedure has been performed under general anesthesia. However, neuraxial and regional anesthesia have become more commonly utilized to aid in postoperative analgesia and reduce the side effects of opioids, namely sedation, nausea, and vomiting. Postoperative pain control has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and overall patient satisfaction.
Lumbar erector spinae plane block (LESPB) was reported to lead to effective postoperative analgesia in hip and proximal femoral surgery.
The fascia iliaca block (FIB) is an established and effective technique, especially when US guidance and proximal approaches are used.
lumbar plexus block (LPB) could be safe because of the targeted somatic nerve block in the psoas region which prevents dispensable sympathetic block even in cardiovascular-compromised patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumbar Erector Spinae Plane Block | Experimental | Other: Lumbar Erector Spinae Plane BlockPatients will receive lumbar erector spinae plane block at the end of surgery. |
| Fascia Iliaca Block | Experimental | Other: Fascia Iliaca BlockPatients will receive fascia iliaca block at the end of surgery. |
| Lumbar Plexus Block | Experimental | Other: Lumbar Plexus BlockPatients will receive lumbar plexus block at the end of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Undergoing total hip arthroplasty under spinal anesthesia.
Key exclusion criteria (9 listed)
- Obesity (Body Mass Index > 30 kg/m2).
- Allergy to any drug used in the study.
- Contraindications to spinal anesthesia (such as Thrombocytopenia (platelets <100,000/mCL) and coagulopathy (INR >1.4 or insufficient time since stopping systemic anticoagulation)).
- Epilepsy.
- Psychiatric disease.
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 |
|---|---|---|
| Lumbar Erector Spinae Plane BlockPatients will receive lumbar erector spinae plane block at the end of surgery. | Other | Lumbar Erector Spinae Plane Block |
| Fascia Iliaca BlockPatients will receive fascia iliaca block at the end of surgery. | Other | Fascia Iliaca Block |
| Lumbar Plexus BlockPatients will receive lumbar plexus block at the end of surgery. | Other | Lumbar Plexus Block |
Primary outcome
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Time to the first request for the rescue analgesia (time from end of block to first dose of morphine administrated) will be recorded.
3 secondary outcomes
Total morphine consumption in the 1st 24h
Time frame: 24 hours postoperatively
Degree of pain
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 18 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 Lumbar Erector Spinae Plane Block, Fascia Iliaca Block and Lumbar Plexus Block in people with Lumbar Erector Spinae Plane Block and Fascia Iliaca 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 4 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 18 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?
Time to the 1st rescue analgesia (time frame: 24 hours postoperatively). 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 18 Apr 2025.