- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06951204
Evaluation of the Role of Genicular Nerve Block When Combined With Adductor Canal Block for Pain Control Following Knee Arthroscopy
Study Overview
Status
Conditions
Detailed Description
A. Preoperative settings:
All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery.
Intraoperative and postoperative settings:
On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted, and IV Ringer's solution will be started, then induction of general anesthesia: Preoxygenation with 100% oxygen will be carried out for 2-3 minutes. Induction of anesthesia will be done using intravenous fentanyl 1-2 µg/kg and propofol 1-2 mg/kg. Endotracheal intubation will be facilitated with atracurium 0.4-0.5 mg/kg. Proper intubation will be confirmed by ETCO2 and bilateral auscultation of the chest. Anesthesia will be maintained with 60:40 oxygen mixed with air and isoflurane 1.2%. Lungs will be ventilated using volume-controlled ventilation with tidal volumes and respiratory rate adjusted to maintain end tidal CO2 at 35-40 MMGH.
After induction of general anesthesia and intubation:
Group A: • All patients will receive adductor canal block under complete aseptic conditions using a high-frequency ultrasound guidance (Sonosite turbo M, Bothell, Washington, USA ). while patient is laying supine lower limbs will slightly abducted at the hips and flexed at the knees , using linear ultrasound probe(2.5-7.5MHZ) on the anterior aspect of the patient's thigh, At the level of mid-thigh, by moving probe medially until the boat shaped Sartorius muscle is visualized , at which the adductor canal is identified beneath the sartorius muscle, a, 20ml bupivacaine (0.25%) will be injected in the canal after a careful negative aspiration. The spread of the drug lateral and around the femoral artery will be seen real time on ultrasound.
Group B: All patients will receive adductor canal block as described above under complete aseptic conditions then they will receive the genicular nerve block using a high-frequency ultrasound guidance (Sonosite turbo M, Bothell, Washington, USA ), genicular nerve block will be done at three locations, i.e., superomedial, superolateral, and inferomedial locations of the condyle-shaft junction, while patient is lying supine linear ultrasound probe(2.5-7.5MHZ) will be used to target the superomedial, superolateral, and inferomedial genicular nerves, 2ml bupivacaine (0.25%) will be injected in the 3 mentioned points after a careful negative aspiration.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11111
- Ain Shams University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Physical status: ASA 1 or 2 and candidates for knee arthroscopy.
- Age group: 18-50 years.
- No sex predilection.
Exclusion Criteria:
- Physical status: ASA III or above.
- Patients with a history of drug allergies to study drugs.
- Previous trauma or surgery to the leg.
- Opioids or alcohol abuse.
- Bleeding tendency.
- Dysesthesia, loss of sensation around the knee or medial aspect of the thigh.
- Inability to cooperate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Adductor canal block (ACB) only
This group will receive Adductor canal block only (control group)
|
All patients will receive adductor canal block under complete aseptic conditions using a high-frequency ultrasound guidance (Sonosite turbo M, Bothell, Washington,USA ). while patient is laying supine lower limbs will slightly abducted at the hips and flexed at the knees , using linear ultrasound probe(2.5-7.5MHZ) on the anterior aspect of the patient's thigh, At the level of mid-thigh, by moving probe medially until the boat shaped Sartorius muscle is visualized , at which the adductor canal is identified beneath the sartorius muscle, 20ml bupivacaine (0.25%) will be injected in the canal after a careful negative aspiration.
The spread of the drug lateral and around the femoral artery will be seen real time on ultrasound
|
|
Active Comparator: Adductor canal block (ACB) combined with Genicular nerve block (GNB)
This group will receive Adductor canal block and Genicular nerve block
|
All patients will receive adductor canal block as described above under complete aseptic conditions then they will receive the genicular nerve block using a high-frequency ultrasound guidance (Sonosite turbo M, Bothell, Washington,USA ), genicular nerve block will be done at three locations, i.e., superomedial, superolateral, and inferomedial locations of the condyle-shaft junction, while patient is lying supine linear ultrasound probe(2.5-7.5MHZ) will be used to target the superomedial, superolateral, and inferomedial genicular nerves,2ml bupivacaine (0.25%) will be injected in the 3 mentioned points after a careful negative aspiration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post-operative pain after 6 hours after the time of administration of the block according to VAS score.
Time Frame: During 24 hours
|
|
During 24 hours
|
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
- FMASU MS170/2024
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.
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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