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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05941221
Other study ID # pericapsular nerve group block
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 30, 2023
Est. completion date September 2023

Study information

Verified date July 2023
Source Ain Shams University
Contact Lydia E Zakhary, MD
Phone 00201222555128
Email lydia_zakhary@med.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the goal of this clinical trial is to evaluate the analgesic effect of pericapsular nerve group (PENG) block in elderly patients with hip fractures undergoing hip surgery . and to evaluate its effect in reducing post operative complications .


Description:

all patients meeting the inclusion criteria will be informed about the study goal , methods and procedure in clear language. a written informed consent will be taken. All patients ,once arrived to the OR, monitor will be attached, spinal anesthesia will be performed as follows, after sterilization of the back with bovidon iodine, local anesthesia 3cc of lidocaine 20% will be injected at the level of L3-L4 spine , then injection of 17 mg bupivacaine 0.5% through a 25 spinal needle. At the end of surgery,all patients will receive PENG block through ultrasound. The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL bupivacaine 0.25%.


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date September 2023
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years to 100 Years
Eligibility Inclusion Criteria: - patients must age 60 years or more . - patients must belong to american society of anesthesiologists (ASA) classification class II or III Exclusion Criteria: - age < 60 years - ASA IIII - refusal of peripheral nerve block - infection at the site of injection - coagulopathy INR > 1.8 - platelets count < 50,000 - known allergy to used medications.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
pericapsular nerve group (PENG) block
patients will receive PENG block through ultrasound. The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed . A 22-gauge, 80-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL bupivacaine 0.25%.

Locations

Country Name City State
Egypt Ain Shams University Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2. — View Citation

Ying H, Chen L, Yin D, Ye Y, Chen J. Efficacy of pericapsular nerve group block vs. fascia iliaca compartment block for Hip surgeries: A systematic review and meta-analysis. Front Surg. 2023 Feb 10;10:1054403. doi: 10.3389/fsurg.2023.1054403. eCollection 2023. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary post operative analgesic effect of PENG block evaluate the analgesic effect of PENG block in the post operative period both at rest and with movement using the Visual analog scale for pain 24 hours
Secondary post operative complications evaluate the effect of PENG block in reducing post operative complications like incidence of delirium using RAMSAY score 24 hours
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