- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06806865
Comparison of Continuous Fascia Iliaca Compartment Block With Continuous PENG Block in Total Hip Replacement Cases (PENG)
Adequate pain management after total hip arthroplasty (THA) is crucial for early ambulation and patient satisfaction. However, due to the hip joint's innervation complexity, the optimal regional analgesia technique for THA remains controversial.
Total hip arthroplasties are critical surgeries that can take steps to improve the quality of life and functional status of patients who do not respond to conservative treatments. However, patients may present with intense pain in the immediate postoperative period, resulting in inactivity, increased risk of complications, and greater opioid consumption, resulting in adverse effects and prolonged hospital stay. The challenging management of pain is explained by the complex innervation of the hip joint, in which the articular branches of the femoral, obturator, and accessory obturator nerves are responsible for the sensory innervation of the anterior capsule.
This randomized clinical trial compares the analgesic efficacy of FICB and PENG block following THA. Our preliminary results will be postoperative pain scores. As our anesthesia clinic, we routinely perform these known methods after surgery in these cases. Traditional intravenous analgesia methods cause many undesirable side effects depending on the type of opioid used, and they are insufficient compared to regional anesthesia methods.
Study Overview
Status
Detailed Description
The pericapsular nerve group (PENG) block has been reported as the first method to target the nerves that supply the hip capsule. Later, several studies said it was more effective than traditional peripheral nerve blocks at treating THA-related postoperative pain. However, a single-injection PENG block is only effective for a limited time. Little evidence supports the efficacy of continuous PENG block for postoperative pain management in THA.
Additional anesthetic techniques, such as peripheral nerve blocks, are part of the multimodal analgesic strategy and are often used to manage acute pain better. Inadequate treatment can lead to a persistent painful condition. Although numerous nerve blocks are available for this purpose, some may fail because they cover only some of the innervation of the anterior hip capsule. The trial hypothesizes that with continuous infusion of the pericapsular nerve group block (PENG block), defined in 2018, the four lateral cutaneous nerve blocks local anesthetic between the thigh-associated psoas muscle tendon plane, and the iliopubic eminence will provide adequate analgesia without causing a motor block. Compared to the infrainguinal approach, the fascia iliaca compartment block (FICB) provides better dissemination under the fascia iliaca, while the local anesthetic is administered more cranially. Desmet et al. showed that supra-inguinal FICB reduced morphine consumption and pain scores following THA. However, despite these promising results, obturator nerve block has not been clinically proven.
Total hip arthroplasties are necessary surgeries that can take steps to improve the quality of life and functional status of patients who do not respond to conservative treatments. However, patients may present with intense pain in the immediate postoperative period, resulting in inactivity, increased risk of complications, and greater opioid consumption, resulting in adverse effects and prolonged hospital stay. The challenging management of pain is explained by the complex innervation of the hip joint, in which the articular branches of the femoral, obturator, and accessory obturator nerves are responsible for the sensory innervation of the anterior capsule.
This randomized clinical trial hypothesizes that PENG block will provide better analgesia and result in fewer quadriceps muscle weakness than FICB following THA. Our preliminary results will be postoperative pain scores. Most anesthesia clinics routinely do this by diversifying these methods known after surgery. Traditional intravenous analgesia methods cause many undesirable side effects depending on the type of opioid used, and they are insufficient compared to regional anesthesia methods.
Since THA patients are generally elderly and with comorbidities, regional anesthesia techniques are safer and more effective.
This study focuses on two routine regional anesthesia techniques that can be safely applied. The trial aims to show which of these two methods is more effective.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Süleymanpasa
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Tekirdağ, Süleymanpasa, Turkey, 59030
- namık kemal üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients undergoing hip replacement for the first time
- Patients aged 18-65 years, ASAI-II (American Society of Anesthesiology classification)
- Patients without primary cancer and/or patients without metastatic bone fractures
- Patients without allergy to local anaesthetics
- Patients with an intellectual level that can use patient-controlled analgesia devices
- Patients with a standard bleeding profile
- Patients who gave written consent to participate in the study
Exclusion Criteria:
- patients who have had a hip replacement and/or revision
- patients who have primary cancer and/or fractures due to bone metastasis
- patients who have a local anaesthetic allergy and/or a history of it
- patients who are not intellectually competent enough to use a patient-controlled anesthesia device
- patients who have undergone reoperation due to any surgical complication (bleeding, etc.) within 24 hours after surgery
- patients who did not give written consent to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PENG Group (periarticular nerve group)
Continuous PENG block is the group to be applied.
|
The pericapsular nerve group (PENG) block targets the nerves that supply the hip capsule.
The continuous PENG block will be applied immediately after general anesthesia is given to the participants under ultrasound guidance.
30 ml of 0.25% bupivacaine will be used.
|
|
Active Comparator: SIFICB Group (supra-inguinal fascia iliaca compartment block)
Continuous supra-inguinal fascia iliaca compartment block is the group to be applied.
|
The supra-inguinal fascia iliaca compartment block (SIFICB) targets the femoral, lateral femoral cutaneous, and obturator nerves.
Under ultrasound guidance, 30 mL of 0.25% bupivacaine is administered, followed by catheter placement for continuous infusion at 5 mL/h.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS scores
Time Frame: up to 24 hours after recovery unit
|
The Visual Analogue Scale (VAS) measures pain intensity.
It consists of a 10 cm line with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be').
Ask the patient to rate their current level of pain by placing a mark on the line.
VAS scores at rest and during movement will be recorded at 0 hours (PACU), and subsequently at 2, 6, 12, and 24 hours while the patient is in the orthopedic clinic.
|
up to 24 hours after recovery unit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total patient-controlled analgesia (PCA) consumption for 24 hours postoperatively
Time Frame: Up to 24 hours
|
A patient-controlled analgesia (PCA) pump is a safe way for people in pain to administer intravenous (I.V.) pain medicine (analgesia) when they need it.
The pump holds a container filled with pain medicine, allowing the patient to control their pain.
A total of 300 mg of tramadol will be used.
3mg/cc.
|
Up to 24 hours
|
|
intraoperative blood pressure
Time Frame: from the beginning of anesthesia induction to the leaving the recovery unit
|
Blood pressure will be monitored and recorded intermittently throughout the surgery.
These parameters may be signs of pain.
|
from the beginning of anesthesia induction to the leaving the recovery unit
|
|
need for additional analgesia or rescue analgesia
Time Frame: up to 24 hours after surgery
|
In cases where pain control is inadequate, when the PCA is locked and the VAS score is five or above, additional analgesics are administered.
Paracetamol 15 mg/kg will be administered as rescue analgesia in the study.
|
up to 24 hours after surgery
|
|
intraoperative heart rate
Time Frame: from the beginning of anesthesia induction up to leaving the recovery unit
|
Heart rate will be monitored and recorded intermittently throughout the surgery.
These parameters may be signs of pain.
|
from the beginning of anesthesia induction up to leaving the recovery unit
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023.06.01.06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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