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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05672784
• Other study ID #: 9577/19-9-2022
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: August 2023
• Source: Zagazig University
• Contact: Heba M Fathi, MD
• Phone: 01000143938
• Email: heba_elgendi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: October 30, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• genicular nerve block plus standard analgesia
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.
• genicular nerve block plus infiltration Between Popliteal Artery and Capsule of Posterior Knee plus standard analgesia
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

Drug:
• standard analgesia (paracetamol and meloxicam)
(paracetamol 1 gm thrice daily and meloxicam (15 mg) every 24).

Locations

Country	Name	City	State
Egypt	Heba M Fathi	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	• 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
Secondary	• Total morphine consumption	Total morphine consumption	at 24, 48 hours postoperatively
Secondary	•incidence of Anticipated side effect	nausea, vomiting, itching, hemorrhage, bradycardia and hypotension.	at 24,48 hours postoperative
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	walk test	walking distance in meters that patients can wake during 2 min)	at 24 and 48 hours post operative
Secondary	walking more than 3 meters	number of patients capable to walk more than 3 meters	at 24 and 48 hours post operative
Secondary	holding quadriceps muscle	number of patients capable to hold quadriceps muscle more than 5 seconds.	at 24 and 48 hours post operative