- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06916000
Assessment of PENG Block as a Part of Multimodal Analgesia Following Hip Surgeries.
Effect of Ultrasound Guided Pericapsular Nerve Group (PENG) Block on Perioperative Pain Management in Patients Undergoing Hip Arthroplasty
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo
-
Abbasia, Cairo, Egypt, 11517
- Faculty of medicine, Ain Shams university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Age group: 18 years and older.
- ASA classification I to III.
- BMI : 18-35 .
- Gender: both sex
Exclusion criteria:
- Patient refusal.
- Patients on long-term pain medications.
- History of allergic reactions to local anesthetics
- Patients who had mental illness or uncooperative patients.
- BMI > 35 .
- Patients having coagulopathies or on anticoagulant or antiplatelet therapy.
- Severe cardiopulmonary disease
- ASA IV or more
- Diabetic or other neuropathies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PENG block group (25 particiants)
For postoperative pain management, all patients of this arm will receive 20 ml of 0.25% bupivcacaine according to the technique described by Giron-Arango. In addition, multimodal analgesia will be given including IV paracetamol 1000 mg BID and oral celecoxib tablet 100 mg BID. Also if needed nalbuphine 5 mg IV will be given as demand dose and when the NRS pain score was equal to or greater than 4 points. |
As a part of multimodal analgesia patients will receive 20 ml of 0.25% bupivcacaine according to the technique described by Giron-Arango. All patients will receive the same analgesic protocol, which included IV paracetamol 1000 mg BID and NSAIDs if no contra-indication; PO celecoxib 100 mg BID. Also if needed nalbuphine 5 mg IV will be given as bolus demand dose and when the NRS pain score was equal to or greater than 4 points. |
|
Experimental: Group C: control group (25 participants)
Patients will receive only other multimodal analgesics
|
Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score: pain assessment using a Numeric Rating System (NRS) immediately in the postoperative period.
Time Frame: 24 hours
|
Pain score: pain intensity will be evaluated using a Numeric Rating System (NRS) immediately in the postoperative period, every 2 hours during the first 6 hours and then every 6 hours till 24 hours postoperatively.
Scores ranging from 0 to 10, with 0 indicating the absence of pain and 10 indicating the worst possible pain.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rescue analgesia timing and opioid consumption over 24 hours
Time Frame: 24 hours
|
Time to first opioid demand and total opioid consumed by each patient individually over 24 hours.
|
24 hours
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MS428/2024
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
product manufactured in and exported from the U.S.
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