AnalgesiaPhase 4NCT05905510
Lumbar Erector Spinae Plane Block and Fascia Iliaca Compartment Block After Total Hip Arthroplasty
A Phase 4 study testing Lumbar Erector spinae plane block (L-ESPB), Fascia iliaca compartment block (FICB) and spinal anesthesia plane block in people with Analgesia, run by Tanta University at 1 site in Egypt.
Trial summary
Compare the analgesic efficacy of ultrasound-guided lumbar erector spinae plane block (L-ESPB) versus fascia iliaca compartment block (FICB) in patients scheduled for total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Lumbar Erector spinae plane block (L-ESPB), Fascia iliaca compartment block (FICB) and spinal anesthesia plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2023to 1 Dec 2023
- Phase
- Phase 4
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 30-75 years from both sexes.
- ASA I-III scheduled for unilateral hip surgery under spinal anesthesia.
Who cannot join
- Patients' refusal.
- Patients who were unable to co-operate with researchers.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- Patients with bleeding and coagulation disorders.
- Patients with renal, hepatic, cardiac decompensation, or spine deformities.
- Patients receiving opioids for chronic analgesic therapy
- Body mass index > 35 kg/m2
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Elgharbia, 31527
Ahmed A Zahran, MBBCh, +20 101 997 6377, ahmad162088@med.tanta.edu.eg
About this study
Official title: Comparative Study Between Ultrasound-Guided Lumbar Erector Spinae Plane Block and Fascia Iliaca Compartment Block for Postoperative Analgesia After Total Hip Arthroplasty
Compare the analgesic efficacy of ultrasound-guided lumbar erector spinae plane block (L-ESPB) versus fascia iliaca compartment block (FICB) in patients scheduled for total hip arthroplasty.
Read the detailed description
Ultrasound-guided erector spinae plane (ESP) block is a recent regional anesthetic technique. It was first described by Forero et al. in 2016 for acute and chronic thoracic pain management. Local anesthetic (LA) is injected between the erector spinae muscle and the vertebra's transverse process, leading to the spread of LA cephalad, caudally, and through the paravertebral space.
- Conditions
- Analgesia
- Being tested
- Lumbar Erector spinae plane block (L-ESPB), Fascia iliaca compartment block (FICB), spinal anesthesia plane 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 block (L-ESPB)Drug
The fourth lumbar vertebral level will be determined using the conventional method (the imaginary line between two crista iliacas). The convex transducer will be placed at the mid-vertebral line in the sagittal plane. The transducer will be shifted from the midline, 3.5-4 cm laterally, to the side of the surgery to visualize the erector spinae muscle and transverse process. Using the out-of-plane technique, a 22G/80-mm block needle will be advanced until it reached the transverse process. 0.5-1 ml of the prepared local anesthesia solution (30 ml bupivacaine 0.25%) will be administered, leading to hydro dissection to confirm the correct location. The needle will be repositioned by pulling back a few millimeters if resistance occurred when administering local anesthesia. All local anesthesia will be administered to this location between the transverse process and the erector spinae muscle
Fascia iliaca compartment block (FICB)Drug
The transducer will be placed laterally to the femoral nerve. It then rotated 90 degrees to the sagittal plane, under ultrasound guidance, a regional block needle (22 G, 80 mm) will be introduced in the cranial direction. Once good needle alignment with the ultrasound beam is achieved, the needle will be inserted deep into the tissues until an optimal position of the needle tip is obtained. Needle location will be additionally verified by injecting 0.5-1 ml of the prepared local anesthesia solution and observing the solution spread within the tissues. Once the correct position of the needle tip is confirmed, the local anesthetic will be deposited under the iliac fascia to force its flow towards the lumbar plexus. 30 ml of bupivacaine 0.25% solution will be used for the block. local anesthesia will be administered as 5 mL boluses with a 20 second interval.
spinal anesthesia plane blockDrug
Patients will receive spinal anesthesia alone
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients will receive spinal anesthesia alone (30 ml bupivacaine 0. 25%). Receives: Drug: spinal anesthesia plane block |
| Lumbar Erector spinae plane block (L-ESPB) | Active comparator | Patients will receive spinal anesthesia and then ipsilateral lumbar erector spinae plane block (30 ml bupivacaine 0. 25%) at the level of the lumbar region in the operating room after the end of the surgery. Receives: Drug: Lumbar Erector spinae plane block (L-ESPB) |
| Fascia iliaca compartment block (FICB) | Active comparator | Patients will receive spinal anesthesia and then ipsilateral suprainguinal fascia iliaca compartment block (30 ml bupivacaine 0. 25%) in the operating room after the end of the surgery. Receives: Drug: Fascia iliaca compartment block (FICB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postoperative pain
Assessment of postoperative pain using the Numeric rating scale (NRS), NRS is a valid and simple approach to pain assessment (0= no pain and 10= worst possible pain)
Measured: UP to 24 hour postoperatively
Secondary outcomes (3)
Time required for the first rescue analgesia.
Morphine sulfate 0.03 mg/kg will be administered intravenous as a rescue analgesic if Numeric rating scale is ≥ 4
Measured: Up to 24 hours postoperatively
The total postoperative rescue analgesic
The total amount of morphine consumption
Measured: first 24 hours postoperatively
Adverse effects
Any complications or undesirable side effects will be observed and treated.
Measured: Up to 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 posted15 Jun 2023
- Study start15 Jun 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ahmed Zahran, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905510
- Sponsor's protocol ID
- 35153/12/21
- Status last verified
- Jun 2023
- First submitted
- 18 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author from one year after study completion
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Ultrasound-Guided Lumbar Erector Spinae Plane Block and Fascia Iliaca Compartment Block for Postoperative Analgesia After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05905510
- Acronym / sponsor ID
- 35153/12/21
- Conditions
- Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 15 Jun 2023 (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.
Compare the analgesic efficacy of ultrasound-guided lumbar erector spinae plane block (L-ESPB) versus fascia iliaca compartment block (FICB) in patients scheduled for total hip arthroplasty.
Detailed description
Ultrasound-guided erector spinae plane (ESP) block is a recent regional anesthetic technique. It was first described by Forero et al. in 2016 for acute and chronic thoracic pain management. Local anesthetic (LA) is injected between the erector spinae muscle and the vertebra's transverse process, leading to the spread of LA cephalad, caudally, and through the paravertebral space.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: spinal anesthesia plane blockPatients will receive spinal anesthesia alone (30 ml bupivacaine 0. 25%). |
| Lumbar Erector spinae plane block (L-ESPB) | Active comparator | Drug: Lumbar Erector spinae plane block (L-ESPB)Patients will receive spinal anesthesia and then ipsilateral lumbar erector spinae plane block (30 ml bupivacaine 0. 25%) at the level of the lumbar region in the operating room after the end of the surgery. |
| Fascia iliaca compartment block (FICB) | Active comparator | Drug: Fascia iliaca compartment block (FICB)Patients will receive spinal anesthesia and then ipsilateral suprainguinal fascia iliaca compartment block (30 ml bupivacaine 0. 25%) in the operating room after the end of the surgery. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 30-75 years from both sexes.
- ASA I-III scheduled for unilateral hip surgery under spinal anesthesia.
Key exclusion criteria (8 listed)
- Patients' refusal.
- Patients who were unable to co-operate with researchers.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- Patients with bleeding and coagulation disorders.
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 block (L-ESPB)The fourth lumbar vertebral level will be determined using the conventional method (the imaginary line between two crista iliacas). The convex transducer will be placed at the mid-vertebral line in the sagittal plane. The transducer will be shifted from the midline, 3.5-4 cm laterally, to the side of the surgery to visualize the erector spinae muscle and transverse process. Using the out-of-plane technique, a 22G/80-mm block needle will be advanced until it reached the transverse process. 0.5-1 ml of the prepared local anesthesia solution (30 ml bupivacaine 0.25%) will be administered, leading to hydro dissection to confirm the correct location. The needle will be repositioned by pulling back a few millimeters if resistance occurred when administering local anesthesia. All local anesthesia will be administered to this location between the transverse process and the erector spinae muscle | Drug | Lumbar Erector spinae plane block (L-ESPB) |
| Fascia iliaca compartment block (FICB)The transducer will be placed laterally to the femoral nerve. It then rotated 90 degrees to the sagittal plane, under ultrasound guidance, a regional block needle (22 G, 80 mm) will be introduced in the cranial direction. Once good needle alignment with the ultrasound beam is achieved, the needle will be inserted deep into the tissues until an optimal position of the needle tip is obtained. Needle location will be additionally verified by injecting 0.5-1 ml of the prepared local anesthesia solution and observing the solution spread within the tissues. Once the correct position of the needle tip is confirmed, the local anesthetic will be deposited under the iliac fascia to force its flow towards the lumbar plexus. 30 ml of bupivacaine 0.25% solution will be used for the block. local anesthesia will be administered as 5 mL boluses with a 20 second interval. | Drug | Fascia iliaca compartment block (FICB) |
| spinal anesthesia plane blockPatients will receive spinal anesthesia alone | Drug | Control Group |
Primary outcome
Assessment of postoperative pain
Time frame: UP to 24 hour postoperatively
Assessment of postoperative pain using the Numeric rating scale (NRS), NRS is a valid and simple approach to pain assessment (0= no pain and 10= worst possible pain)
3 secondary outcomes
Time required for the first rescue analgesia.
Time frame: Up to 24 hours postoperatively
The total postoperative rescue analgesic
Time frame: first 24 hours postoperatively
Adverse effects
Time frame: Up to 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author from one year after study completion
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lumbar Erector spinae plane block (L-ESPB), Fascia iliaca compartment block (FICB) and spinal anesthesia plane block in people with Analgesia, 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 2 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Ahmed Zahran, MBBCH (+20 101 997 6377, ahmad162088@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of postoperative pain (time frame: UP to 24 hour 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 22 Jun 2023.