- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07046377
- Original Trial
Comparison Between Two Blocks in Analgesia After Knee Arthroplasty
Comparative Study Between Adductor Canal Block Combined With (IPACK) Block Versus Genicular Nerves Block Combined With (IPACK) Block Regarding Postoperative Analgesic Effect After Knee Replacement Surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patient informed written consent and ethical committee approval of Faculty of Medicine; Ain Shams University will be obtained before patient allocation.
• Study procedures: Supervisors and experts will do all the study procedures.
Patients undergoing unilateral Total knee replacement (TKR) will be randomly assigned into one of the following groups using computer generated codes (15 patients in each group):
Group 1 (ACB - IPACK group): will receive spinal anesthesia and ultrasound-guided Adductor canal nerve block, as well as infiltration of the space between the popliteal artery and the capsule of the posterior knee (IPACK) block.
Group 2 (GNB - IPACK group): will recieve spinal anesthesia and US guided Genicular nerves block and IPACK block.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Ain shams university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 30-85 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical Status Class I to III.
- Patients scheduled for unilateral TKA under spinal anesthesia.
Exclusion Criteria:
- Patient's refusal.
- American Society of Anesthesiologists (ASA) Physical Status Class above III.
- local infection.
- History of allergy to the medications used in the study. 5. Psychiatric disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1
Adductor canal block + IPACK group
|
will receive spinal anesthesia and ultrasound-guided Adductor canal nerve block, as well as infiltration of the space between the popliteal artery and the capsule of the posterior knee (IPACK) block.
|
|
Active Comparator: Group 2
Genicular nerves block + IPACK block.
|
will recieve spinal anesthesia and US guided Genicular nerves block and IPACK block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1- Comparing both groups regarding the time needed ( in hours) for the first call rescue analgesia post operatively.
Time Frame: 5 minutes after ending of operation
|
Total knee replacement (TKR) is a well-known popular surgical procedure for knee diseases, including end-stage knee osteoarthritis that causes severe postoperative pain and prolonged immobility. Acute pain control can be provided with multimodal analgesia, including non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. However, NSAIDs cause many side effects as peptic ulcer and gastritis, also opioids have gastrointestinal side effects as constipation, nausea and vomiting as well as respiratory depression. Regional analgesia has been used as another modality to provide sufficient perioperative pain relief with minimal opioid consumption to avoid it's adverse effects peripheral nerve blocks (PNBs) is a common practice in orthopedic surgery. PNBs provide excellent pain management after TKA, promote early mobilization, and reduce the consumption of opioids, the incidence of opioid-related adverse effects, and the hospital stay |
5 minutes after ending of operation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mai Ma Abd ElAziz, MBBCH, Ain shams university
- Principal Investigator: Mai Ma Abd ElAziz Ibrahim, MBBCH, Ain shams university
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 (Estimated)
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
- FMASU MS64/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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