- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05997940
Effectiveness Of The Pericapsular Nerve Group (PENG) Block In Hip Surgery
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.
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 Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kadir Berkay TAN, Resident Doctor
- Phone Number: +905393506273
- Email: k.berkay.tan@adu.edu.tr
Study Contact Backup
- Name: Mustafa OGURLU, Professor Doctor
- Phone Number: +905326056932
- Email: mogurlu@adu.edu.tr
Study Locations
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-
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Aydın, Turkey
- Recruiting
- Adnan Menderes University Faculty of Medicine
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Contact:
- Kadir Berkay TAN, Resident Doctor
- Phone Number: +905393506273
- Email: k.berkay.tan@adu.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with written informed consent
- Patients over 18 years old
- Patients with ASA score I-II-III
- Patients performed spinal anesthesia for surgery
Exclusion Criteria:
- 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
- Patients with liver and kidney failure
- Patients who are allergic to the drugs used
- Patients with major complications during the operation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
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Active Comparator: PENG
PENG block performed before spinal anesthesia
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
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Preoperative
|
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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).
|
During the spinal anesthesia
|
|
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).
|
Postoperative 0. hour
|
|
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).
|
Postoperative 1. hour
|
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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).
|
Postoperative 6. hour
|
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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).
|
Postoperative 12. hour
|
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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).
|
Postoperative 24. hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amounts of postoperative analgesic consumption
Time Frame: Postoperative 24 hours
|
Postoperative analgesic consumption amounts will be compared between the patients performed PENG block and the control group.
|
Postoperative 24 hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022/03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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-
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Clinical Trials on PENG block
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Ospedale Edoardo BassiniRecruitingRegional Anesthesia Morbidity | Arthropathy of Hip | Opioid Consumption | Hip Arthropathy | Complication of Anesthesia | Locoregional Anesthesia | Hospital Stay, Length of Stay in Hospital From Time of Surgery Till DischargeItaly
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Mansoura UniversityCompleted
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Ankara City Hospital BilkentRecruiting
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Diskapi Teaching and Research HospitalCompleted
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Karaman Training and Research HospitalCompleted
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Fayoum University HospitalRecruitingPostoperative Pain | Femoral Neck Fractures | Hip Arthroplasty | Hip Fracture SurgeriesEgypt