Genicular Nerve Block Versus Its Combination With Infiltration Between Popliteal Artery and Capsule of Posterior Knee

Study Overview
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Brief Summary
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comparing Genicular Nerve Block with its combination with infiltration Between Popliteal Artery and Capsule of Posterior Knee for Enhanced Recovery After total Knee Arthroplasty

Detailed Description
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comparing the use of Genicular Nerve Block versus its combination with infiltration Between Popliteal Artery and Capsule of Posterior Knee as a preemptive analgesia for Enhanced Recovery After total Knee Arthroplasty

Official Title
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Genicular Nerve Block Versus Its Combination With Infiltration Between Popliteal Artery and Capsule of Posterior Knee for Enhanced Recovery After Total Knee Arthroplasty

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: genicular nerve block plus standard analgesia
* Procedure: genicular nerve block plus infiltration Between Popliteal Artery and Capsule of Posterior Knee plus standard analgesia
* Drug: standard analgesia (paracetamol and meloxicam)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adult patients aged between 21 to 60 years undergoing primary unilateral elective total knee arthroplasty under spinal anesthesia Having informed consents patients with physical status ASA I & II both genders body mass index between 25 and 30 kg/m2. Exclusion criteria patients with Peripheral vascular disease patients with history of allergy to local anesthesia or opioid analgesia, those on anti-platelet, anticoagulant or B blocker drugs Patients with acute decompensated heart failure Patients with hypertension Patients with heart block Patients with coronary disease Patients with bronchial asthma Patients with bleeding disorders Patients with compromised renal or hepatic function pregnant female.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C group<br>the patients will take standard analgesia (paracetamol 1 gm thrice daily and meloxicam (15 mg) every 24). ,with no nerve block | Drug: standard analgesia (paracetamol and meloxicam)<br>* (paracetamol 1 gm thrice daily and meloxicam (15 mg) every 24).<br>* Other names: standard analgesia with no nerve block;|
| Active Comparator: G group<br>the patients will take standard analgesia plus genicular nerves block | Procedure: genicular nerve block plus standard analgesia<br>* In supine position with a pillow under the popliteal fossa, a 12 MHz linear transducer (XarioTM SSA-660A, Toshiba Medical Systems Corporation, Otawara, Japan) will be placed parallel to the shaft of long bones of the legs. The target points will be next to superior lateral, superior medial, and inferior medial genicular arteries to block the superior lateral, superior medial, and inferior medial branches of genicular nerve. Identification will be done using color Doppler near the periosteal areas (the junctions of the epicondyle and the shafts of the femur and tibia, accordingly). The needle will be inserted in the plane of the ultrasound probe in the long-axis view. After confirming the placement of the needle-tip next to the genicular arteries, a 2.5 mL of bupivacaine (5%) will be injected at each target points.<br>* Other names: genicular block and standard analgesia;Drug: standard analgesia (paracetamol and meloxicam)<br>* (paracetamol 1 gm thrice daily and meloxicam (15 mg) every 24).<br>* Other names: standard analgesia with no nerve block;|
| Active Comparator: GI group<br>the patients will take standard analgesia plus genicular nerves block plusinfiltration Between Popliteal Artery and Capsule of Posterior Knee | Procedure: genicular nerve block plus infiltration Between Popliteal Artery and Capsule of Posterior Knee plus standard analgesia<br>* IPACK block will be performed in supine position with flexion of the knee in 45o. low frequency transducer at a depth of 3.5-4 cm will be placed transversely over the medial aspect of the knee, 2-3 cm above the patella, with sliding the transducer proximally and distally to identify the distal part of the shaft of the femur and the popliteal artery ( If the two femoral condyles appear first, proximal sliding of the probe until the humps of the femoral condyles disappeared and the flat metaphysis appeared). Advance the needle in plane toward the space between the popliteal artery and the femur then 15 ml of bupivacaine 0.5% will be injected plus genicular nerve block<br>* Other names: genicular bock and IPACK block and standard analgesia;Drug: standard analgesia (paracetamol and meloxicam)<br>* (paracetamol 1 gm thrice daily and meloxicam (15 mg) every 24).<br>* Other names: standard analgesia with no nerve block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 hours visual analogue scale | pain intensity at rest and with motion using visual analogue scale from  horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10. | at1hour after recovery from spinal anesthesia. | 
| 4 hours visual analogue score | pain intensity at rest and with motion using visual analogue scale from  horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10. | at 4 hours after recovery from spinal anesthesia | 
| 6 hours visual analogue score | pain intensity at rest and with motion using visual analogue scale from  horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10. | at 6 hours after recovery from spinal anesthesia | 
| 12 hours visual analogue score | pain intensity at rest and with motion using visual analogue scale from  horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10. | at 12 hours after recovery from spinal anesthesia | 
| 24 hours visual analogue score | pain intensity at rest and with motion using visual analogue scale from  horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10. | at 24 hours after recovery from spinal anesthesia | 
| 48 hours visual analogue score | pain intensity at rest and with motion using visual analogue scale from  horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10. | at 48 hours after recovery from spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Time of performance of block | defined as time from putting of U.S probe till the end of block procedure. | from putting of U.S probe till the end of block procedure | 
| • Total morphine consumption | Total morphine consumption | at 24, 48 hours postoperatively | 
| •incidence of Anticipated side effect | nausea, vomiting, itching, hemorrhage, bradycardia and hypotension. | at 24,48 hours postoperative | 
| blood presure | measured by noninvasive blood pressure monitoring | measured every 15 minutes from beginning of surgery until the end of surgery then every hour during the 1st 48 hours post operative | 
| heart rate | heart rate measured by electrocardiography | measured every 15 minutes from beginning of surgery until the end of surgery then every hour during the 1st 48 hours post operative | 
| oxygen saturation | measured by pulse oximeter | measured every 15 minutes from beginning of surgery until the end of surgery then every hour during the 1st 48 hours post operative | 
| degree of maximum active flexion of the knee | degree of maximum active flexion of the knee comparing to the preoperative state | at 24 and 48 hours post operative | 
| time of first mobilization after surgery | the first time when the patient start to walk( measured by hours ) | at 24 and 48 hours post operative | 
| walk test | walking distance in meters that patients can wake during 2 min) | at 24 and 48 hours post operative | 
| walking more than 3 meters | number of patients capable to walk more than 3 meters | at 24 and 48 hours post operative | 
| holding quadriceps muscle | number of patients capable to hold quadriceps muscle more than 5 seconds. | at 24 and 48 hours post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genicular ,IPACK, total knee