PENG and LFCN Block Versus Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty
Primary Purpose
Post Operative Pain, Regional Block
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pericapsular nerve group and lateral femoral cutaneous nerve block
lumbar plexus block
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Pain focused on measuring PENG, lumber plexus, hip surgery
Eligibility Criteria
Inclusion Criteria: (ASA) physical status I to III scheduled for hip surgery aged (30-70) years Exclusion Criteria: Drug allergy, Morbid obesity (BMI >40 kg/m2), Coagulopathy, Psychiatric disorder, Opioid dependence, Patient refusal to give informed consent.
Sites / Locations
- Minia UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PENG and LFCN
lumbar plexus
Arm Description
Outcomes
Primary Outcome Measures
Visual analogue scale pain scores
pain score from 0-10 which 0 mean no pain and 10 the worst pain
Secondary Outcome Measures
first analgesic request
time to demand nalbuphine
total analgesic consumption
total nalbuphine in mg consumed in the first day
First time to ambulate
first time to move
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05652075
Brief Title
PENG and LFCN Block Versus Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty
Official Title
Efficacy and Safety of Ultrasound Guided Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Versus Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty: Randomized Clinical Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia 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
Regional anesthesia for postoperative analgesia in THA includes epidural anesthesia and peripheral nerve blocks. However epidural anesthesia has a great role in THA, it has become restricted as perioperative antithrombotic drugs are generally used for orthopedic patients.
the study aim to evaluate and compare efficacy and safety of pericapsular nerve group block (PENG) block and lateral femoral cutaneous nerve versus Lumbar plexus block on postoperative analgesia in hip surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Regional Block
Keywords
PENG, lumber plexus, hip surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PENG and LFCN
Arm Type
Experimental
Arm Title
lumbar plexus
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
pericapsular nerve group and lateral femoral cutaneous nerve block
Intervention Description
Will undergo pericapsular nerve group block (PENG) combined with lateral femoral cutaneous nerve under ultrasound guided block with 20 mL of 0.25% bupivacaine.
Intervention Type
Procedure
Intervention Name(s)
lumbar plexus block
Intervention Description
Will undergo Lumbar plexus block (LPB) under ultrasound guided block with 20 mL of 0.25 % bupivacaine.
Primary Outcome Measure Information:
Title
Visual analogue scale pain scores
Description
pain score from 0-10 which 0 mean no pain and 10 the worst pain
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
first analgesic request
Description
time to demand nalbuphine
Time Frame
24 hour
Title
total analgesic consumption
Description
total nalbuphine in mg consumed in the first day
Time Frame
24 hour
Title
First time to ambulate
Description
first time to move
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(ASA) physical status I to III scheduled for hip surgery aged (30-70) years
Exclusion Criteria:
Drug allergy,
Morbid obesity (BMI >40 kg/m2),
Coagulopathy,
Psychiatric disorder,
Opioid dependence,
Patient refusal to give informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hassan m. hetta, lecturer
Phone
1010901114
Ext
0020
Email
hassan.hetta@mu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hassan m. hetta, lecturer
Organizational Affiliation
minia university/ faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minia University
City
Minya
State/Province
Minia
ZIP/Postal Code
61511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hassan M. Hetta, MSc
Phone
1204427271
Ext
0020
Email
Hassan.Hetta@mu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PENG and LFCN Block Versus Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty
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