Post Operative Pain ManagementNCT03783247
Peri-capsular Nerve Group Block Versus Fascia Iliaca Block for Hip Arthroplasty
A study testing Pericapsular nerve group block and Fascia Iliaca BLock in people with Post Operative Pain Management, run by Cairo University at 1 site in Egypt.
Trial summary
In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG) block in hip surgeries as a post-operative pain management technique in comparison with fascia Iliaca block in hip surgeries Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Operative Pain Management
- What is being tested?
- Pericapsular nerve group block and Fascia Iliaca BLock
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2019to 20 Jun 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for hip replacement surgeries e.g. hip hemiarthroplasty, total hip arthroplasty under subarachnoid block (SAB)
Who cannot join
- Coagulopathy
- infection at the injection site
- allergy to local anesthetics
- severe cardiopulmonary disease (≥ASA IV)
- diabetic or other neuropathies
- patients receiving opioids for chronic analgesic therapy
- contraindication to spinal anesthesia
- inability to comprehend visual analog scale (VAS).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Hip Arthroplasty: a Randomized Controlled Trial
In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG) block in hip surgeries as a post-operative pain management technique in comparison with fascia Iliaca block in hip surgeries
Read the detailed description
Hip fracture is a common orthopedic emergency in the elderly, and it is associated with significant morbidity and mortality.1 Surgical reduction and fixation are the definitive treatment in most patients.2 Effective perioperative analgesia that minimizes the need for opioids and related adverse effects (such as delirium) is essential in this patient population.
Regional analgesic techniques, including femoral nerve (FN) block, fascia iliaca block (FIB), and 3-in-1 FN block, are popular analgesic strategies, due mainly to their opioid-sparing effects and reduction in opioid-related adverse effects. The effect size of analgesia from these blocks is only moderate, and literature suggests that the obturator nerve (ON) is not covered.
The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as reported by previous anatomic studies. The anterior capsule is the most richly innervated section of the joint, suggesting these nerves should be the main targets for hip analgesia. A recent anatomical study by Short et al15 confirmed the innervation of the anterior hip by these 3 main nerves but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported. This study also identified the relevant landmarks for those articular branches. The high articular branches from FN and AON are consistently found between the anterior inferior iliac spines (AIIS) and the iliopubic eminence (IPE), whereas the ON , close to the inferomedial acetabulum. Using this information, the investigator developed an ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (PEricapsular Nerve Group) block. In this study, the investigator will examine the efficacy of PENG block in hip surgeries as a post-operative pain management technique in comparison with fascia Iliaca block in hip surgeries
- Conditions
- Post Operative Pain Management
- Being tested
- Pericapsular nerve group block, Fascia Iliaca BLock
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
Also called PENG
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 (Figs. 2, 3). 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 (20ml of bupivacaine 0.25%) was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 30 mL
Fascia Iliaca BLockProcedure or surgery
Also called FIB
In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest \& iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.
| Study group | Role | What they receive |
|---|---|---|
| FIB | Experimental | hip fracture with fascia Iliaca block Receives: Procedure: Fascia Iliaca BLock |
| PENG | Experimental | Hip fracture with Pericapsular nerve group block Receives: Procedure: Pericapsular nerve group block |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
total morphine consumption over 24 hours
Measured: 24 hours
Secondary outcomes (2)
pain scale Visual analogue Scale
Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 24hours
muscle power
Assessment of quadriceps femoris muscle strength: For motor block assessment, the patient will be in supine position and the patient's knee will be fully flexed, and the patient will be asked to extend it. The motor block is classified as follows: grade 0; normal muscle power, grade I; motor weakness, grade II; complete motor paralysis
Measured: 24 HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start15 Feb 2019 (estimated)
- Primary completion31 May 2019 (estimated)
- Study completion20 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain ManagementStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized double-blinded
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mohamed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783247
- Sponsor's protocol ID
- Swelam PENG block
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2018
- Last updated
- 21 Dec 2018
- 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 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Hip Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03783247
- Acronym / sponsor ID
- Swelam PENG block
- Conditions
- Post Operative Pain Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 20 Jun 2019 (estimated)
- First posted
- 21 Dec 2018 (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.
In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG) block in hip surgeries as a post-operative pain management technique in comparison with fascia Iliaca block in hip surgeries
Detailed description
Hip fracture is a common orthopedic emergency in the elderly, and it is associated with significant morbidity and mortality.1 Surgical reduction and fixation are the definitive treatment in most patients.2 Effective perioperative analgesia that minimizes the need for opioids and related adverse effects (such as delirium) is essential in this patient population.
Regional analgesic techniques, including femoral nerve (FN) block, fascia iliaca block (FIB), and 3-in-1 FN block, are popular analgesic strategies, due mainly to their opioid-sparing effects and reduction in opioid-related adverse effects. The effect size of analgesia from these blocks is only moderate, and literature suggests that the obturator nerve (ON) is not covered.
The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as reported by previous anatomic studies. The anterior capsule is the most richly innervated section of the joint, suggesting these nerves should be the main targets for hip analgesia. A recent anatomical study by Short et al15 confirmed the innervation of the anterior hip by these 3 main nerves but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported. This study also identified the relevant landmarks for those articular branches. The high articular branches from FN and AON are consistently found between the anterior inferior iliac spines (AIIS) and the iliopubic eminence (IPE), whereas the ON , close to the inferomedial acetabulum. Using this information, the investigator developed an ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (PEricapsular Nerve Group) block. In this study, the investigator will examine the efficacy of PENG block in hip surgeries as a post-operative pain management technique in comparison with fascia Iliaca block in hip surgeries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double-blinded
| Arm | Type | Receives |
|---|---|---|
| FIB | Experimental | Procedure: Fascia Iliaca BLockhip fracture with fascia Iliaca block |
| PENG | Experimental | Procedure: Pericapsular nerve group blockHip fracture with Pericapsular nerve group block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for hip replacement surgeries e.g. hip hemiarthroplasty, total hip arthroplasty under subarachnoid block (SAB)
Key exclusion criteria (8 listed)
- Coagulopathy
- infection at the injection site
- allergy to local anesthetics
- severe cardiopulmonary disease (≥ASA IV)
- diabetic or other neuropathies
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 blockAlso: PENGThe 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 (Figs. 2, 3). 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 (20ml of bupivacaine 0.25%) was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 30 mL | Procedure or surgery | PENG |
| Fascia Iliaca BLockAlso: FIBIn supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest \& iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml. | Procedure or surgery | FIB |
Primary outcome
morphine consumption
Time frame: 24 hours
total morphine consumption over 24 hours
2 secondary outcomes
pain scale Visual analogue Scale
Time frame: 24hours
muscle power
Time frame: 24 HOURS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- 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 Fascia Iliaca BLock in people with Post Operative Pain Management, run by Cairo 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 Dec 2018. 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?
Results are not available in the source record.
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: 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 21 Dec 2018.