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Effect of Pericapsular Nerve Group (PENG) Block for Perioperative Analgesia in Geriatric Patients With Hip Fractures

Primary Purpose

Hip Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pericapsular nerve group (PENG) block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Fractures

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study group

Arm Description

patients will receive pericapsular nerve group (PENG )block through ultrasound at the end of the surgery.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

post operative complications
evaluate the effect of PENG block in reducing post operative complications like incidence of delirium using RAMSAY score

Full Information

First Posted
June 24, 2023
Last Updated
July 3, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05941221
Brief Title
Effect of Pericapsular Nerve Group (PENG) Block for Perioperative Analgesia in Geriatric Patients With Hip Fractures
Official Title
Effect of Pericapsular Nerve Group (PENG) Block for Perioperative Analgesia in Geriatric Patients With Hip Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 .
Detailed 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
patients will receive pericapsular nerve group (PENG )block through ultrasound at the end of the surgery.
Intervention Type
Procedure
Intervention Name(s)
pericapsular nerve group (PENG) block
Intervention Description
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%.
Primary Outcome Measure Information:
Title
post operative analgesic effect of PENG block
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
post operative complications
Description
evaluate the effect of PENG block in reducing post operative complications like incidence of delirium using RAMSAY score
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lydia E Zakhary, MD
Phone
00201222555128
Email
lydia_zakhary@med.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
samuel H Daniel, MD
Phone
00201224394897
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lydia E zakhary
Phone
01222555128
Email
lydia_zakhary@med.asu.edu.eg

12. IPD Sharing Statement

Citations:
PubMed Identifier
35933328
Citation
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.
Results Reference
background
PubMed Identifier
36843984
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.
Results Reference
background

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Effect of Pericapsular Nerve Group (PENG) Block for Perioperative Analgesia in Geriatric Patients With Hip Fractures

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