Pericapsular Nerve Group Block in Hip Arthroplasty
Primary Purpose
Post Operative Pain After Hip Arthroplasty
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pericapsular nerve group block
Sponsored by
About this trial
This is an interventional supportive care trial for Post Operative Pain After Hip Arthroplasty
Eligibility Criteria
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.
Sites / Locations
- Tarek Abdel Hay
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
group 1
group 2
Arm Description
will receive sham PENG block with normal saline in total volume of 20 ml.
will receive real PENG block with bupivacaine (0.25%) in total volume of 20 ml.
Outcomes
Primary Outcome Measures
first time of rescue analgesia.
first time of rescue morphine analgesia.
Secondary Outcome Measures
postoperative morphine consumption
postoperative morphine consumption as rescue analgesia
pain score
pain score by numerical rating score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04336059
Brief Title
Pericapsular Nerve Group Block in Hip Arthroplasty
Official Title
Pericapsular Nerve Group Block in Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
Hip joint is richly innervated, and the pain following hip arthroplasty is particularly severe. Effective postoperative analgesic technique especially in an elderly with significant comorbidities is challenging. (1) 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. (2) These techniques have shown effective and safe postoperative pain control, resulting in lower opioid consumption, improved earlier rehabilitation and high patient satisfaction. (3) Pericapsular nerve group (PENG) block has been recently recommended by Giron-Arango et al. for use as postoperative analgesia in hip surgeries. It is a new regional anesthesia method based on blocking the articular branches of femoral nerve (FN) and accessory obturator nerve(AON) and obturator nerve in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence (IPE).The anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia. (4)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain After Hip Arthroplasty
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Other
Arm Description
will receive sham PENG block with normal saline in total volume of 20 ml.
Arm Title
group 2
Arm Type
Experimental
Arm Description
will receive real PENG block with bupivacaine (0.25%) in total volume of 20 ml.
Intervention Type
Procedure
Intervention Name(s)
pericapsular nerve group block
Intervention Description
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.
Primary Outcome Measure Information:
Title
first time of rescue analgesia.
Description
first time of rescue morphine analgesia.
Time Frame
postoperative first day
Secondary Outcome Measure Information:
Title
postoperative morphine consumption
Description
postoperative morphine consumption as rescue analgesia
Time Frame
postoperative first day
Title
pain score
Description
pain score by numerical rating score
Time Frame
postoperative first day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tarek Abdel Hay
City
Tanta
State/Province
El Gharbyia
ZIP/Postal Code
31527
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Pericapsular Nerve Group Block in Hip Arthroplasty
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