Lower Limb FractureNCT06019754
Combined Lumbar and Sacral Branches Block Through the Ilio-Psoas Muscle Spaces for Analgesia of Lower Limb Surgeries
A study testing one point combined Lumbar and sacral plexus block in people with Lower Limb Fracture, run by Zagazig University at 1 site in Egypt.
Trial summary
lumbosacral plexus block (LSPB) has been widely applied in orthopedics departments due to its advantages, including reduction in the application of opiates, decreasing the occurrence of acute pain, promoting early activation, and shortening the time of hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lower Limb Fracture
- What is being tested?
- one point combined Lumbar and sacral plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2023to 4 Sep 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II.
- patients scheduled for unilateral femur or tibial surgery necessitate knee joint intervention
- patients who have severe pain hindering changing their position or patients who have spinal fractures or refusing spinal anesthesia.
- patients with the capability of communication
Who cannot join
- puncture site infection
- patients with coagulation disorders
- patients who refuse to participate or withdraw due to personal reasons
- allergy to local anesthetics.
- past surgery at the site of the block
- hip ankylosis
Show all 12Show fewer
- drug abuse
- Body mass index ≥ 35 kg/m2
- peripheral vascular insufficiency
- use of alpha or beta blocker agents
- Nerve injury or neuropathy of the affected lower limb
- cardiovascular or respiratory decompansation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The One-Point Puncture Anterior Approach of the Combined Lumbar and Sacral Plexuses Block for Analgesia of Lower Limb Orthopedic Surgeries
lumbosacral plexus block (LSPB) has been widely applied in orthopedics departments due to its advantages, including reduction in the application of opiates, decreasing the occurrence of acute pain, promoting early activation, and shortening the time of hospital stay. LSPB is a peripheral regional technique of anesthesia and analgesia, that provides a block of the main components of the lumbosacral plexus.
Read the detailed description
Traditional ultrasound-guided lumbar plexus block combined with sacral plexus block requires separate blocks at different sites, requiring the lateral decubitus or prone position, which may be suboptimal in patients with severe pain. we present an anterior approach for combined lumbar and sacral plexus blocks with a one-point puncture.
- Conditions
- Lower Limb Fracture
- Being tested
- one point combined Lumbar and sacral plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one point combined Lumbar and sacral plexus blockProcedure or surgery
Also called No block intervention in control group
performing an ultrasound-guided one-point combined Lumbar and sacral plexus block using a one-point puncture. Block success will be assessed using the perfusion index (PI) before and after performing the block
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | patients who will be recruited in the control group will receive general anesthesia only Receives: Procedure: one point combined Lumbar and sacral plexus block |
| Interventional group | Active comparator | Patients who will be recruited in the Interventional will receive one point combined lumbar and sacral plexus block. then they will receive general anesthesia Receives: Procedure: one point combined Lumbar and sacral plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative and postoperative opioid consumption
The total fentanyl doses consumed in the entire operative procedure and morphine consumed for 24 hours postoperative will be calculated.
Measured: Total fentanyl used intraoperative and total morphine consumed up to 24 hours postoperative
Secondary outcomes (2)
(NRS) score assessment pre-block, 30 min post-block , and postoperatively in the recovery room, and then it will be repeated 3 h, 6h, 12h, and 24, hours
Numerical Pain Score (NRS) ranges from 0 to 10, where 0 is no pain, and 10 is the worst pain imaginable. Adequate pain control will be considered at Numerical Pain Score (NRS) < 4.
Pain will be assessed using (the NRS) score preoperatively before the block and 30 min post-block, then postoperatively in the recovery room, 3 h, 6h, 12h, and 24 hours.
Measured: preoperative and postoperatively pain (NRS) score assessment for 24 hours
Block success assessment using perfusion index (PI) before and after performing the block
Perfusion index (PI) values rise with successful peripheral nerve blocks. If PI is not changed, this means block failure
Measured: Recording Perfusion index readings at baseline and 10, 20, 30 min. post block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start10 Sep 2023
- Primary completion1 Sep 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb FractureStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using a point puncture approach instead of two punctures to perform lumbosacral plexuses block in the interventional group.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Naglaa Fathy Abdelhaleem Abdelhaleem, Zagazig University
- Investigators
- Naglaa Abdelhaleem, MD, Principal investigator, Faculty of medicine, Zagazig University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019754
- Sponsor's protocol ID
- IRB#10892
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2023
- Last updated
- 11 Aug 2025
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The One-Point Puncture Anterior Approach of the Combined Lumbar and Sacral Plexuses Block for Analgesia of Lower Limb Orthopedic Surgeries
- ClinicalTrials.gov ID
- NCT06019754
- Acronym / sponsor ID
- IRB#10892
- Conditions
- Lower Limb Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 31 Aug 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.
lumbosacral plexus block (LSPB) has been widely applied in orthopedics departments due to its advantages, including reduction in the application of opiates, decreasing the occurrence of acute pain, promoting early activation, and shortening the time of hospital stay. LSPB is a peripheral regional technique of anesthesia and analgesia, that provides a block of the main components of the lumbosacral plexus.
Detailed description
Traditional ultrasound-guided lumbar plexus block combined with sacral plexus block requires separate blocks at different sites, requiring the lateral decubitus or prone position, which may be suboptimal in patients with severe pain. we present an anterior approach for combined lumbar and sacral plexus blocks with a one-point puncture.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Using a point puncture approach instead of two punctures to perform lumbosacral plexuses block in the interventional group.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Procedure: one point combined Lumbar and sacral plexus blockpatients who will be recruited in the control group will receive general anesthesia only |
| Interventional group | Active comparator | Procedure: one point combined Lumbar and sacral plexus blockPatients who will be recruited in the Interventional will receive one point combined lumbar and sacral plexus block. then they will receive general anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I-II.
- patients scheduled for unilateral femur or tibial surgery necessitate knee joint intervention
- patients who have severe pain hindering changing their position or patients who have spinal fractures or refusing spinal anesthesia.
- patients with the capability of communication
Key exclusion criteria (12 listed)
- puncture site infection
- patients with coagulation disorders
- patients who refuse to participate or withdraw due to personal reasons
- allergy to local anesthetics.
- past surgery at the site of the block
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 |
|---|---|---|
| one point combined Lumbar and sacral plexus blockAlso: No block intervention in control groupperforming an ultrasound-guided one-point combined Lumbar and sacral plexus block using a one-point puncture. Block success will be assessed using the perfusion index (PI) before and after performing the block | Procedure or surgery | Control group, Interventional group |
Primary outcome
Total intraoperative and postoperative opioid consumption
Time frame: Total fentanyl used intraoperative and total morphine consumed up to 24 hours postoperative
The total fentanyl doses consumed in the entire operative procedure and morphine consumed for 24 hours postoperative will be calculated.
2 secondary outcomes
(NRS) score assessment pre-block, 30 min post-block , and postoperatively in the recovery room, and then it will be repeated 3 h, 6h, 12h, and 24, hours
Time frame: preoperative and postoperatively pain (NRS) score assessment for 24 hours
Block success assessment using perfusion index (PI) before and after performing the block
Time frame: Recording Perfusion index readings at baseline and 10, 20, 30 min. post block
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 11 Aug 2025.
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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.
Naglaa Abdelhaleem, MD principal investigator
Faculty of medicine, Zagazig University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one point combined Lumbar and sacral plexus block in people with Lower Limb Fracture, run by Zagazig 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 12 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 11 Aug 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. Some participants in this study may receive a placebo. 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?
Total intraoperative and postoperative opioid consumption (time frame: Total fentanyl used intraoperative and total morphine consumed up to 24 hours postoperative). 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 11 Aug 2025.