Comparison Between Pericapsular Nerve Group Block (PENG) and Morphine Infusion
Primary Purpose
Analgesia, Femur Fracture
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pericapsular nerve group block
Morphine Sulfate
Sponsored by
About this trial
This is an interventional supportive care trial for Analgesia
Eligibility Criteria
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
Sites / Locations
- Suez Canal University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PENG block+ morhine
MORPHINE
Arm Description
the participants will receive PENG block before being attached to morphine PCA
The participants will be given morphine PCA without PENG block
Outcomes
Primary Outcome Measures
morphine consumption
compare the total morphine consumption in milligrams that is given by patient-controlled analgesia device (PCA)
Secondary Outcome Measures
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
Incidence of nausea and vomiting
desire to vomit or actual vomiting as prescribed yeas or no
Full Information
NCT ID
NCT05023473
First Posted
August 14, 2021
Last Updated
September 12, 2022
Sponsor
Suez Canal University
1. Study Identification
Unique Protocol Identification Number
NCT05023473
Brief Title
Comparison Between Pericapsular Nerve Group Block (PENG) and Morphine Infusion
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University
4. Oversight
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
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Femur Fracture
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PENG block+ morhine
Arm Type
Active Comparator
Arm Description
the participants will receive PENG block before being attached to morphine PCA
Arm Title
MORPHINE
Arm Type
Active Comparator
Arm Description
The participants will be given morphine PCA without PENG block
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group block
Intervention Description
patients will receive pericapsular nerve group block
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Intervention Description
morphine will be given to both groups as patient-controlled analgesia PCA
Primary Outcome Measure Information:
Title
morphine consumption
Description
compare the total morphine consumption in milligrams that is given by patient-controlled analgesia device (PCA)
Time Frame
immediately at the end of 24 hours
Secondary Outcome Measure Information:
Title
Numeric rating scale (NRS)
Description
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
Time Frame
immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest
Title
Incidence of nausea and vomiting
Description
desire to vomit or actual vomiting as prescribed yeas or no
Time Frame
immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Suez Canal University
City
Ismailia
ZIP/Postal Code
41511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison Between Pericapsular Nerve Group Block (PENG) and Morphine Infusion
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