Comparison Between Pericapsular Nerve Group Block (PENG) and Morphine Infusion

Analgesia Clinical Trial

Official title:

Comparison Between Pericapsular Nerve Group Block (Peng) and Morphine Infusion in Reducing the Pain of Proximal Femur Fracture in the Emergency Department, a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05023473
• Other study ID #: PENG block
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The pericapsular nerve group block (PENG) is a regional anaesthetic technique that was developed in 2018, primarily for total hip arthroplasties (THA) as a postoperative analgesia modality with motor sparing benefits.

The block is thought to provide more complete analgesia to the hip by depositing local anaesthetic within the myofascial plane of the psoas muscle and superior pubic ramus.

In this study, the investigators will assess the effect of pericapsular nerve group (PENG) block on pain control in patients with proximal femur fracture in the emergency department.

The Control group will receive morphine as regular patient control analgesia (PCA) The interventional group will receive PENG block before being attached to regular morphine PCA

Description:

The pericapsular nerve group block (PENG) is a regional anaesthetic technique that was developed in 2018, primarily for total hip arthroplasties (THA) as a postoperative analgesia modality with motor sparing benefits.

The block is thought to provide more complete analgesia to the hip by depositing local anaesthetic within the myofascial plane of the psoas muscle and superior pubic ramus.

The indications for THA often include degenerative hip disease and traumatic hip fractures. These indications for surgery are relatively common in the elderly population and are associated with significant morbidity and mortality.

Operative intervention, such as THA, has also been associated with significant pain.

Historically, the most commonly performed peripheral nerve blocks include a lumbar plexus block, a femoral nerve block, or a fascia iliaca compartment block to manage post-operative analgesia.

With the understanding that additional articular branches (i.e., from the sciatic nerve) these blocks will provide incomplete analgesia to the hip and may also predispose the patient to fall due to weakness of the quadriceps muscles.

Therefore the ideal block technique should provide complete analgesia of the hip joint and without muscle weakness.

The PENG has been described for postoperative pain control for surgery at the hip joint or the management of post-traumatic pain associated with fractures of the proximal femur/ femoral head.

There are currently no unique contraindications that are specific to the PENG block. Therefore, similar guidelines applicable to most peripheral nerve blocks would apply and include:

• Lack of patient consent

• Skin infection at the site of injection

• Systemic bacteremia or sepsis

• Anticoagulation and antithrombotic medications precautions as detailed by the American society of regional anaesthesia for peripheral nerve blocks The hip joint has a complex innervation, and the pain following hip fractures or total hip arthroplasties is particularly severe. An appropriate plan for perioperative analgesia is challenging, but a multimodal approach including acetaminophen, cox-2 selective NSAIDs, regional anaesthesia, and periarticular infiltration techniques improves patient outcomes.

The ultrasound-guided PENG block allows for coverage of the hip joint, targeting the proximal articular branches that innervate the joint capsule. This proximal approach via ultrasound guidance can confer several advantages over a femoral nerve block by providing more complete analgesia to the hip joint. Additionally, the motor function of the involved extremity should be spared. The PENG block can be used alone as a primary analgesic or in conjunction with other forms of anaesthesia during surgery or in the perioperative period. For lateral surgical incisions, a supplemental lateral femoral cutaneous nerve block provides additional coverage.

With the patient in the supine position, the ultrasound probe is placed on a transverse plane over the anterior superior iliac spine (ASIS). Once the ASIS is identified, the transducer is aligned with the pubic ramus and rotated at approximately 45 degrees, parallel to the inguinal crease. The transducer is then slid medially along this axis until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and the psoas tendon is identified, serving as anatomic landmarks.

Sliding the probe distally or gently tilting the caudal will expose the head of the femur. Returning to the initial starting position, a standard 20-22 gauge 100mm needle is inserted in-plane, from lateral to medial, in the plane between the psoas tendon and the pubic ramus. 15-20ml of a long-lasting local anaesthetic ((i.e., 0.5% ropivacaine) is then deposited in this plane, lifting the psoas tendon. Care should be taken to avoid puncturing the psoas tendon. In this study, the investigators will assess the effect of pericapsular nerve group (PENG) block on pain control in patients with proximal femur fracture in the emergency department.

The Control group will receive morphine as regular patient control analgesia (PCA) The interventional group will receive PENG block before being attached to regular morphine PCA

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 1, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients are aged 18-70 years.

• Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status grade II) = (patients with mild systemic disease and no functional limitations).

• Patients having post-traumatic pain associated with fractures of the proximal femur or femoral head.

Exclusion Criteria:

• Patient refusal to participate in the study

• Known allergy to LA.

• Body mass index (BMI) more than 40 kg/m2

• Heart block greater than first degree

• Renal, and hepatic dysfunction

• Underlying coagulopathies

Related Conditions & MeSH terms

• Analgesia
• Femoral Fractures
• Femur Fracture

Intervention

Procedure:
• Pericapsular nerve group block
patients will receive pericapsular nerve group block

Drug:
• Morphine Sulfate
morphine will be given to both groups as patient-controlled analgesia PCA

Locations

Country	Name	City	State
Egypt	Suez Canal University	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption	compare the total morphine consumption in milligrams that is given by patient-controlled analgesia device (PCA)	immediately at the end of 24 hours
Secondary	Numeric rating scale (NRS)	A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable	immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest
Secondary	Incidence of nausea and vomiting	desire to vomit or actual vomiting as prescribed yeas or no	immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest