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

Sponsor
Suez Canal University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05023473
Collaborator
(none)
60
1
2
5
11.9

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pericapsular nerve group block
  • Drug: Morphine Sulfate
N/A

Detailed 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Aug 15, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PENG block+ morhine

the participants will receive PENG block before being attached to morphine PCA

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

Active Comparator: MORPHINE

The participants will be given morphine PCA without PENG block

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

Outcome Measures

Primary Outcome Measures

  1. morphine consumption [immediately at the end of 24 hours]

    compare the total morphine consumption in milligrams that is given by patient-controlled analgesia device (PCA)

Secondary Outcome Measures

  1. Numeric rating scale (NRS) [immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest]

    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

  2. Incidence of nausea and vomiting [immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest]

    desire to vomit or actual vomiting as prescribed yeas or no

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Suez Canal University Ismailia Egypt 41511

Sponsors and Collaborators

  • Suez Canal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abdelrhman Alshawadfy, Lecturer of anesthesia and intensive care, Suez Canal University
ClinicalTrials.gov Identifier:
NCT05023473
Other Study ID Numbers:
  • PENG block
First Posted:
Aug 26, 2021
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022