Coupling of IPACK Block With Adductor Canal Block Versus Adductor Canal Block Alone on Pain, Functional Recovery and Inflammatory Response After Knee Replacement

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorAin Shams University

About this trial

The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement as well as Functional Recovery and Inflammatory Response and range of motion postoperatively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing total knee replacement.

ASA physical status I to III

Sex (males and females).

Age 20 - 70 years.

Disqualifiers

Patients undergoing bilateral or revision total knee replacement.

ASA physical status more than III

Age less than 20 or older than 70

severe renal insufficiency ( Estimated Glomerular filtration rate eGFR < 15 mL/min/1.73 m2 ).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adductor Canal Block (ACB) + iPACK Block

    Procedure/Surgery

    Adductor Canal Block (ACB) in the immediate preoperative period under a high-frequency ultrasound guidance in which the adductor canal is identified beneath the sartorius muscle and 20 ml of bupivacaine 0.25% will be injected in the canal using a 22-gaugusing a 22-gauge 100-mm short-bevelled regional block needle. IPACK Block which the patient will be placed in a supine position and knee will be placed in position of 90° flexion. A low-frequency ultrasound probe will be positioned in the popliteal crease, and a spinal needle will be inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 15 ml of bupivacaine 0.25% will be injected after negative aspiration.

  • Adductor Canal Block (ACB) + iPACK Block (sham injection)

    Procedure/Surgery

    All patients will receive Adductor Canal Block in the immediate preoperative period under a high-frequency ultrasound guidance in which the adductor canal is identified beneath the sartorius muscle and 20 ml of bupivacaine 0.25% will be injected in the canal using a 22-gauge 100-mm short-bevelled regional block needle IPACK block which the patient will be placed in a supine position and knee will be placed in position of 90° flexion. A low-frequency ultrasound probe will be positioned in the popliteal crease, and a spinal needle will be inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 15 ml of normal saline will be injected after negative aspiration.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Adductor canal block (ACB) + IPACK blockActive comparator 1 intervention
Group B: Adductor Canal Block (ACB) + IPACK (sham injection)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement.

Total cumulative dose of used morphine (mg) to control pain will be recorded at 0 hour -6 hours, 6 hours -12 hours and 12 hours - 24 hours after surgery from postoperative in post anaesthesia care unit and in orthopaedic wards as primary outcome of the study.

Time frame
At 0 hour -6 hours, 6 hours-12 hours and 12 hours - 24 hours after surgery

Secondary outcomes

1

The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively

Assessment of pain ( by 11 point numeric pain rating scale) after completing the surgical procedure and wear off of spinal analgesia that will be confirmed by modified Bromage scale and cold sensation. Assessment of pain scores at rest and during active flexion 45◦ will be recorded at 8 hours, 12 hours and 24 hours postoperatively, patients will be asked to rate perceived pain using an 11-point Numeric Pain Rating Scale (NRS: 0= no pain and 10= worst pain) experienced at rest and during active flexion 45◦.

Time frame
Postoperative Pain scores at rest and during active flexion 45◦ will be recorded at 8 hours, 12 hours and 24 hours postoperative.
2

The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively

Range of motion and quadriceps strength (by extent of knee extension) will be measured to grade the functional recovery of the knee joint after surgery after the first 10 hours postoperatively. The extent of knee extension will be used to quantify the range of motion (ROM). The interval of activities will be recorded three times a day with 6 hours apart.

Time frame
Range of motion and quadriceps strength will be measured after first 10 hours, three times a day with 6 hours apart.
3

The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively.

Blood samples for neutrophil-lymphocytic ratio (NLR) (normal range in normal male and female are 0.43 - 2.75 and 0.37 - 2.87 respectively) and platelet-lymphocytic ratio (PLR) (normal range in male and female are 36.63 - 149.13 and 43.36 - 172.68 respectively) will be collected at 12 hours and 24 hours postoperative.

Time frame
Neutrophil-lymphocytic ratio and Platelet-lymphocytic ratio will be collected at 12 hours and 24 hours postoperative.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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