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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06019754
Other study ID # IRB#10892
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 10, 2023
Est. completion date June 1, 2024

Study information

Verified date May 2024
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. LSPB is a peripheral regional technique of anesthesia and analgesia, that provides a block of the main components of the lumbosacral plexus.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 56
Est. completion date June 1, 2024
Est. primary completion date May 25, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - ASA I-II. - patients diagnosed with lower limb fracture by X-ray or CT examination necessitate intraoperative tourniquet application - patients with any contraindications to spinal anesthesia - patients who have severe pain hindering changing their position or patients who have spinal fractures - 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 - drug abuse - peripheral vascular insufficiency - use of alpha or beta blocker agents - Nerve injury of the affected lower limb

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
one 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

Locations

Country Name City State
Egypt Faculty of Medicine - Zagazig University Zagazig

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Total fentanyl used intraoperative and total morphine consumed up to 24 hours postoperative
Secondary (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.
preoperative and postoperatively pain (NRS) score assessment for 24 hours
Secondary 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 Recording Perfusion index readings at baseline and 10, 20, 30 min. post block
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