PENG BlockNCT05997940
Effectiveness Of The Pericapsular Nerve Group (PENG) Block In Hip Surgery
A study testing PENG block in people with PENG Block, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The target population of hip surgery is usually the elderly patients with systemic comorbidity. Especially hip fractures are common in society and cause high morbidity and mortality for geriatric patients . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PENG Block
- What is being tested?
- PENG block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with written informed consent
- Patients over 18 years old
- Patients with ASA score I-II-III
- Patients performed spinal anesthesia for surgery
Who cannot join
- Patients without written informed consent
- Patients with ASA score IV and above
- Patients who cannot be communicated
- Patients with infection at the block site
- Patients with coagulation disorders
- Patients not suitable for spinal anesthesia
Show all 9Show fewer
- Patients with liver and kidney failure
- Patients who are allergic to the drugs used
- Patients with major complications during the operation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adnan Menderes University Faculty of Medicine
Aydin
Kadir Berkay TAN, Resident Doctor, +905393506273, k.berkay.tan@adu.edu.tr
About this study
Official title: Evaluation Of The Postoperative Analgesic Effectiveness Of The Pericapsular Nerve Group Block Performed Before Spinal Anesthesia In Hip Surgery
The target population of hip surgery is usually the elderly patients with systemic comorbidity. Especially hip fractures are common in society and cause high morbidity and mortality for geriatric patients . Pain felt before and during surgery can cause metabolic and endocrine changes in the body, leading to sleep disorders, depression, delirium, dementia and persistent chronic pain. With effective postoperative analgesia, it is possible to reduce postoperative complications and mortality and accelerate post-surgical recovery. Pharmacological methods such as opioids and NSAIDs used for this may cause further deterioration and other side effects in geriatric patients with reduced renal and hepatic function, thus delaying post-surgical recovery and thus discharge. In order to avoid these side effects, regional anesthesia techniques can be preferred.
Regional anesthesia techniques are among the most effective methods of postoperative analgesia. Peripheral nerve blocks are also one of the regional anesthesia methods. Peripheral nerve blocks; They are the most ideal postoperative analgesia methods because they provide effective analgesia, reduce the need for opioids and consequently their side effects, are effective in the treatment of dynamic pain and facilitate recovery.
Read more
Patients undergoing hip surgery have very severe pain and need additional postoperative analgesics. Mobilization of patients is delayed due to pain . Depending on this , thromboembolism , deep vein The risk of nosocomial infection increases due to thrombosis , wound infection and increased length of stay.
Alleviating the pain around the hip joint capsule is an effective analgesia method in hip surgeries. The anterior capsule of the hip joint is innervated by the femoral , obturator , and accessory obturator nerves . Pericapsular nerve group (PENG) block also targets these nerves. Many studies have shown that PENG block provides adequate analgesia for more than 24 hours postoperatively. PENG block is a method that is frequently used in the world and in our clinic and has a low complication rate.
In this study, the investigators aimed to show that pericapsular nerve group block performed before spinal anesthesia in hip surgeries reduces postoperative pain and decreases total opioid consumption.
- Conditions
- PENG Block
- Being tested
- PENG block
- Keywords
- Pericapsular nerve group (PENG) block, Postoperative analgesia, Hip Surgery, Regional anesthesia, Spinal anesthesia
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG blockDrug
The PENG block was performed with the patient in the supine position at preoperative waiting room. A curvilinear low-frequency ultrasound probe (2-5 MHz) 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. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22 gauge, 100 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 was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL
| Study group | Role | What they receive |
|---|---|---|
| PENG | Active comparator | PENG block performed before spinal anesthesia Receives: Drug: PENG block |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Measured: Preoperative
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Measured: During the spinal anesthesia
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Measured: Postoperative 0. hour
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Measured: Postoperative 1. hour
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Measured: Postoperative 6. hour
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Measured: Postoperative 12. hour
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Measured: Postoperative 24. hour
Secondary outcomes (1)
Amounts of postoperative analgesic consumption
Postoperative analgesic consumption amounts will be compared between the patients performed PENG block and the control group.
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Oct 2022
- Primary completion15 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PENG BlockStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ogurlu, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997940
- Sponsor's protocol ID
- 2022/03
- Status last verified
- Aug 2023
- First submitted
- 11 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Postoperative Analgesic Effectiveness Of The Pericapsular Nerve Group Block Performed Before Spinal Anesthesia In Hip Surgery
- ClinicalTrials.gov ID
- NCT05997940
- Acronym / sponsor ID
- 2022/03
- Conditions
- PENG Block
- Keywords
- Pericapsular nerve group (PENG) block, Postoperative analgesia, Hip Surgery, Regional anesthesia, Spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 18 Aug 2023 (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 target population of hip surgery is usually the elderly patients with systemic comorbidity. Especially hip fractures are common in society and cause high morbidity and mortality for geriatric patients . Pain felt before and during surgery can cause metabolic and endocrine changes in the body, leading to sleep disorders, depression, delirium, dementia and persistent chronic pain. With effective postoperative analgesia, it is possible to reduce postoperative complications and mortality and accelerate post-surgical recovery. Pharmacological methods such as opioids and NSAIDs used for this may cause further deterioration and other side effects in geriatric patients with reduced renal and hepatic function, thus delaying post-surgical recovery and thus discharge. In order to avoid these side effects, regional anesthesia techniques can be preferred.
Regional anesthesia techniques are among the most effective methods of postoperative analgesia. Peripheral nerve blocks are also one of the regional anesthesia methods. Peripheral nerve blocks; They are the most ideal postoperative analgesia methods because they provide effective analgesia, reduce the need for opioids and consequently their side effects, are effective in the treatment of dynamic pain and facilitate recovery.
Patients undergoing hip surgery have very severe pain and need additional postoperative analgesics. Mobilization of patients is delayed due to pain . Depending on this , thromboembolism , deep vein The risk of nosocomial infection increases due to thrombosis , wound infection and increased length of stay.
Alleviating the pain around the hip joint capsule is an effective analgesia method in hip surgeries. The anterior capsule of the hip joint is innervated by the femoral , obturator , and accessory obturator nerves . Pericapsular nerve group (PENG) block also targets these nerves. Many studies have shown that PENG block provides adequate analgesia for more than 24 hours postoperatively. PENG block is a method that is frequently used in the world and in our clinic and has a low complication rate.
In this study, the investigators aimed to show that pericapsular nerve group block performed before spinal anesthesia in hip surgeries reduces postoperative pain and decreases total opioid consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG | Active comparator | Drug: PENG blockPENG block performed before spinal anesthesia |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with written informed consent
- Patients over 18 years old
- Patients with ASA score I-II-III
- Patients performed spinal anesthesia for surgery
Key exclusion criteria (9 listed)
- Patients without written informed consent
- Patients with ASA score IV and above
- Patients who cannot be communicated
- Patients with infection at the block site
- Patients with coagulation disorders
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 |
|---|---|---|
| PENG blockThe PENG block was performed with the patient in the supine position at preoperative waiting room. A curvilinear low-frequency ultrasound probe (2-5 MHz) 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. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22 gauge, 100 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 was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL | Drug | PENG |
Primary outcome
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time frame: Preoperative
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time frame: During the spinal anesthesia
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time frame: Postoperative 0. hour
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time frame: Postoperative 1. hour
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time frame: Postoperative 6. hour
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time frame: Postoperative 12. hour
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time frame: Postoperative 24. hour
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
1 secondary outcome
Amounts of postoperative analgesic consumption
Time frame: Postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG block in people with PENG Block, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 4 inclusion and 9 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 18 Aug 2023. 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 Turkey (Türkiye). 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?
Contact Kadir Berkay TAN, Resident Doctor (+905393506273, k.berkay.tan@adu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) for postoperative analgesic efficacy (time frame: Preoperative). The study lists 7 primary outcomes in all. 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 18 Aug 2023.