Single-injection Modified 4 in 1 Block as Postoperative Analgesia in Total Knee Arthroplasty

NCT ID: NCT05447871

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2023-07-31

Brief Summary

Patients suffer from moderate to severe pain after TKA. Patients are asked to begin functional exercise as early as possible after surgery, and that requires adequate control of postoperative pain. Regional anesthesia divides into non-motor sparing peripheral nerve blocks as femoral n. block and sciatic n. block and motor sparing peripheral nerve block as adductor canal block and IPACK but these blocks have many drawbacks.

So new studies found that a modified 4 in-1 block blocks all these nerves and produces adequate analgesia without sparing areas.

Detailed Description

Total knee arthroplasty (TKA) is regarded as the most effective method to reduce knee pain and improve knee function in patients with advanced knee osteoarthritis. Postoperative pain is an unpleasant experience for TKA and this pain might greatly influence patients' early rehabilitation.

Almost 60% of patients suffer moderate to severe pain after TKA and 25% of them could even develop related complications, such as longer hospitalization stays, unanticipated hospital admissions, readmissions, etc.

With the development of enhanced recovery after surgery, patients are asked to begin exercise as early as possible after surgery, and that requires adequate control of postoperative pain.

Multimodal systemic analgesia plays an essential role in controlling postoperative pain after TKA by controlling the inflammatory process, dealing with the neuropathic component of pain, and thus reducing the severity of pain.

Multimodal analgesia includes more than one pain-control modality (systemic analgesia and regional anaesthesia). Systemic analgesia includes acetaminophen, nonsteroidal anti-inflammatory drugs, steroids and opioids. Regional anaesthesia includes epidural analgesia, femoral n. block, adductor canal block, sciatic n. block, IPACK, etc. Regional anaesthesia divides into non-motor sparing peripheral nerve blocks as femoral n. block and sciatic n. block and motor sparing peripheral nerve block as adductor canal block and IPACK.

But these blocks have many drawbacks. Femoral n. block is associated with quadriceps muscle weakness leading to delay in patient's mobility. Sciatic n. block also causes foot drop. The Adductor canal block does not cover the skin on the back of the knee. Surgeons refuse IPACK because of diffusion of local anaesthetics disturbs the anatomy of the surgical field.

The Modified 4 in 1 block technique aims to block four nerves (saphenous nerve, obturator nerve, nerve to vastus medialis and sciatic nerve) through a single injection point by spreading up to the adductor canal in midthigh and below to the popliteal fossa. The investigator will conduct this randomized clinical trial to evaluate the quality of postoperative analgesia produced by a single injection modified 4 in 1 block and midsartorius adductor canal block with regard to total analgesic consumption in the first 24 hours postoperatively

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Ultrasound guided single injection modified 4 in 1 block technique

Patients in this group will receive ultrasound guided single injection modified 4 in 1 block with 25 ml bupivacaine 0.25%

Group Type: EXPERIMENTAL

Ultrasound guided single injection modified 4 in 1 block technique

Intervention Type: PROCEDURE

A high-frequency ultrasound probe is placed over the femoral condyle and vastus medialis muscle is identified. The probe is slid proximally till the superficial femoral artery appeared. The probe is slid proximally till the descending genicular artery branching from the superficial femoral artery. The point of interest is 8-10 cm above the femoral condyle. The needle is guided into the Vastus medialis muscle till the nerve to Vastus medialis. At this point, 5-7 mL of the local anaesthetic drug is injected. The needle is guided further in-plane from lateral to medial side to reach the perivascular region and after negative aspiration 25 ml local anaesthetic drug is injected.

Bupivacaine 0.25%

Intervention Type: DRUG

bupivacaine 0.25%

Ultrasound guided adductor canal block technique

Patients in this group will receive ultrasound guided aduuctor canal block with 20 ml bupivacaine 0.25%

Group Type: ACTIVE_COMPARATOR

Ultrasound guided adductor canal block technique

Intervention Type: PROCEDURE

The Adductor canal is identified in the middle of the thigh beneath the sartorius muscle using a high-frequency ultrasonic transducer. the probe is slid till the superficial femoral artery appeared in the adductor canal between vastus medialis and adductor longus muscle. A 22-gauge spinal needle is inserted in a lateral to medial plane to reach the perivascular region and after negative aspiration 20 ml local anaesthetic drug is injected, visualised to push the femoral artery.

Bupivacaine 0.25%

Intervention Type: DRUG

bupivacaine 0.25%

Interventions

Ultrasound guided single injection modified 4 in 1 block technique

A high-frequency ultrasound probe is placed over the femoral condyle and vastus medialis muscle is identified. The probe is slid proximally till the superficial femoral artery appeared. The probe is slid proximally till the descending genicular artery branching from the superficial femoral artery. The point of interest is 8-10 cm above the femoral condyle. The needle is guided into the Vastus medialis muscle till the nerve to Vastus medialis. At this point, 5-7 mL of the local anaesthetic drug is injected. The needle is guided further in-plane from lateral to medial side to reach the perivascular region and after negative aspiration 25 ml local anaesthetic drug is injected.

Intervention Type: PROCEDURE

Ultrasound guided adductor canal block technique

The Adductor canal is identified in the middle of the thigh beneath the sartorius muscle using a high-frequency ultrasonic transducer. the probe is slid till the superficial femoral artery appeared in the adductor canal between vastus medialis and adductor longus muscle. A 22-gauge spinal needle is inserted in a lateral to medial plane to reach the perivascular region and after negative aspiration 20 ml local anaesthetic drug is injected, visualised to push the femoral artery.

Intervention Type: PROCEDURE

Bupivacaine 0.25%

bupivacaine 0.25%

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) of 19-30 kg/m2
• American Society of Anesthesiologists (ASA) functional status of I-III

Exclusion Criteria

• Drug hypersensitivity
• coagulopathy
• infection at the site of injection
• Traumatic arthirits

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gehan A Trabeeh, MD

Role: STUDY_CHAIR

Professor of Anesthesia and Surgical Intensive Care

Samah A Gouda, MD

Role: STUDY_DIRECTOR

Assistant Professor of Anesthesia and Surgical Intensive Care

Samar A Alattar, M.Sec

Role: PRINCIPAL_INVESTIGATOR

Assistant lecturer of Anesthesia and Surgical Intensive Care

Locations

Mansoura University

Al Mansurah, DK, Egypt

Countries

Egypt

Central Contacts

Gehan A Trabeeh, MD

Role: CONTACT

gehan_tarbeeh2011@hotmail.com

00201061618512

Samah A Gouda, MD

Role: CONTACT

Sk_20022000@yahoo.com

00201002262557

Facility Contacts

Gehan A Trabeeh, MD

Role: primary

gehan_tarbeeh2011@hotmail.com

00201061618512

Samah A Gouda, MD

Role: backup

Sk_20022000@yahoo.com

00201002262557

Other Identifiers

MFM-IRB: MD. 22.03.629

Identifier Type: -

Identifier Source: org_study_id