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Combined Lumbar and Sacral Branches Block Through the Ilio-Psoas Muscle Spaces for Analgesia of Lower Limb Surgeries

The One-Point Puncture Anterior Approach of the Combined Lumbar and Sacral Plexuses Block for Analgesia of Lower Limb Orthopedic Surgeries

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06019754
Enrollment
56
Registered
2023-08-31
Start date
2023-09-10
Completion date
2024-09-04
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Fracture

Brief 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. 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.

Interventions

PROCEDUREone point combined Lumbar and sacral plexus block

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

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

Randomization assignments will be kept in sealed envelopes until all preprocedural measurements will be completed

Intervention model description

Using a point puncture approach instead of two punctures to perform lumbosacral plexuses block in the interventional group.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Total intraoperative and postoperative opioid consumptionTotal fentanyl used intraoperative and total morphine consumed up to 24 hours postoperativeThe total fentanyl doses consumed in the entire operative procedure and morphine consumed for 24 hours postoperative will be calculated.

Secondary

MeasureTime frameDescription
(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, hourspreoperative and postoperatively pain (NRS) score assessment for 24 hoursNumerical 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.
Block success assessment using perfusion index (PI) before and after performing the blockRecording Perfusion index readings at baseline and 10, 20, 30 min. post blockPerfusion index (PI) values rise with successful peripheral nerve blocks. If PI is not changed, this means block failure

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026