- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04336059
Pericapsular Nerve Group Block in Hip Arthroplasty
Peripheral nerve blocks are becoming increasingly popular for hip surgery anesthesia. Modern regional anesthesia for major hip surgery includes the use of a single shot and continuous epidural or spinal injections, continuous lumbar plexus blockade and continuous peripheral blockade of the femoral nerve (FN), fascia iliaca (FI) block, 3-in-1 FN block and sciatic nerve. The use of either single shot or continuous peripheral nerve blocks are becoming increasingly popular.
This study will be conducted to evaluate the effect of ultrasound guided pericapsular nerve group block in hip arthroplasty surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
El Gharbyia
-
Tanta, El Gharbyia, Egypt, 31527
- Tarek Abdel Hay
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients will involve in the research if they will schedule for unilateral hip arthroplasty (THA) surgery.
- aged more than 50 years of both genders.
- have American society of anesthiologists physical status I-II and III.
Exclusion Criteria:
- Revision hip arthroplasty.
- hip arthroplasty. combined with subtrochanteric shortening osteotomy.
- drug allergy.
- regular narcotic use.
- renal &/ or hepatic impairments.
- coagulopathy disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: group 1
will receive sham PENG block with normal saline in total volume of 20 ml.
|
The regional block will be performed with the patient in the supine position under complete sterile technique. A low frequency curvilinear ultrasound probe will be initially placed in a transverse plane over the anterior inferior iliacspine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminance(IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will observed. A 22-gauge, 80-mm needle will be 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 after local infiltration of the site of the block with 3 ml lidocaine 2%. Following negative aspiration,the normal saline solution will injected in 5-mL increments while observing for adequate fluid spread in this plane. |
Experimental: group 2
will receive real PENG block with bupivacaine (0.25%) in total volume of 20 ml.
|
The regional block will be performed with the patient in the supine position under complete sterile technique. A low frequency curvilinear ultrasound probe will be initially placed in a transverse plane over the anterior inferior iliacspine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminance(IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will observed. A 22-gauge, 80-mm needle will be 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 after local infiltration of the site of the block with 3 ml lidocaine 2%. Following negative aspiration,the normal saline solution will injected in 5-mL increments while observing for adequate fluid spread in this plane. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
first time of rescue analgesia.
Time Frame: postoperative first day
|
first time of rescue morphine analgesia.
|
postoperative first day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative morphine consumption
Time Frame: postoperative first day
|
postoperative morphine consumption as rescue analgesia
|
postoperative first day
|
pain score
Time Frame: postoperative first day
|
pain score by numerical rating score
|
postoperative first day
|
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- hip arthroplasty
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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