AnalgesiaNCT05023473
Comparison Between Pericapsular Nerve Group Block (PENG) and Morphine Infusion
A study testing Pericapsular nerve group block and Morphine Sulfate in people with Analgesia and Femur Fracture, run by Suez Canal University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Analgesia, Femur Fracture
- What is being tested?
- Pericapsular nerve group block and Morphine Sulfate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
Read the 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
- Conditions
- Analgesia, Femur Fracture
- Being tested
- Pericapsular nerve group block, Morphine Sulfate
- Medical subject headings
- Agnosia, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group blockProcedure or surgery
patients will receive pericapsular nerve group block
Morphine SulfateDrug
morphine will be given to both groups as patient-controlled analgesia PCA
| Study group | Role | What they receive |
|---|---|---|
| PENG block+ morhine | Active comparator | the participants will receive PENG block before being attached to morphine PCA Receives: Procedure: Pericapsular nerve group block; Drug: Morphine Sulfate |
| MORPHINE | Active comparator | The participants will be given morphine PCA without PENG block Receives: Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
compare the total morphine consumption in milligrams that is given by patient-controlled analgesia device (PCA)
Measured: immediately at the end of 24 hours
Secondary outcomes (2)
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
Measured: immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest
Incidence of nausea and vomiting
desire to vomit or actual vomiting as prescribed yeas or no
Measured: immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Apr 2022
- Primary completion15 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023473
- Sponsor's protocol ID
- PENG block
- Status last verified
- Sep 2022
- First submitted
- 14 Aug 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05023473
- Acronym / sponsor ID
- PENG block
- Conditions
- Analgesia, Femur Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG block+ morhine | Active comparator | Procedure: Pericapsular nerve group block, Drug: Morphine Sulfatethe participants will receive PENG block before being attached to morphine PCA |
| MORPHINE | Active comparator | Drug: Morphine SulfateThe participants will be given morphine PCA without PENG block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pericapsular nerve group blockpatients will receive pericapsular nerve group block | Procedure or surgery | PENG block+ morhine |
| Morphine Sulfatemorphine will be given to both groups as patient-controlled analgesia PCA | Drug | MORPHINE, PENG block+ morhine |
Primary outcome
morphine consumption
Time frame: immediately at the end of 24 hours
compare the total morphine consumption in milligrams that is given by patient-controlled analgesia device (PCA)
2 secondary outcomes
Numeric rating scale (NRS)
Time frame: immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest
Incidence of nausea and vomiting
Time frame: immediately after starting morphine infusion 0,2,4,6,8,10,12,14,16,18,20,22,24 hours at rest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular nerve group block and Morphine Sulfate in people with Analgesia and Femur Fracture, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine consumption (time frame: immediately at the end of 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.