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

• Sponsor: Ain Shams University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05941221
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5.1
• Patients Per Site Per Month: 3.1

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures	Procedure: pericapsular nerve group (PENG) block	N/A

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%.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Pericapsular Nerve Group (PENG) Block for Perioperative Analgesia in Geriatric Patients With Hip Fractures
• Actual Study Start Date: Mar 30, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

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

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%.

Outcome Measures

Primary Outcome Measures

1. post operative analgesic effect of PENG block [24 hours]

   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

1. post operative complications [24 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospital	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Lydia edward aziz zakhary, Principal Investigator, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05941221
• Other Study ID Numbers: pericapsular nerve group block
• First Posted: Jul 12, 2023
• Last Update Posted: Jul 12, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fractures, Bone; Hip Fractures

Study Results

No Results Posted as of Jul 12, 2023