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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Procedure: Ultrasound guided single injection modified 4 in 1 block technique; Drug: Bupivacaine 0.25%; Procedure: Ultrasound guided adductor canal block technique

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

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gehan A Trabeeh, MD; Phone Number: 00201061618512; Email: gehan_tarbeeh2011@hotmail.com
• Study Contact Backup: Name: Samah A Gouda, MD; Phone Number: 00201002262557; Email: Sk_20022000@yahoo.com

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Mansoura University
      • Contact: Gehan A Trabeeh, MD; Phone Number: 00201061618512; Email: gehan_tarbeeh2011@hotmail.com
      • Contact: Samah A Gouda, MD; Phone Number: 00201002262557; Email: Sk_20022000@yahoo.com
      • Sub-Investigator: Mohamed M Tawfik, MD
      • Principal Investigator: Samar A Alattar, M.Sec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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%	Procedure: 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.; Drug: Bupivacaine 0.25%; bupivacaine 0.25%
Active Comparator: Ultrasound guided adductor canal block technique; Patients in this group will receive ultrasound guided aduuctor canal block with 20 ml bupivacaine 0.25%	Drug: Bupivacaine 0.25%; bupivacaine 0.25%; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of postoperative analgesia in first 24 hours	calculate total amount of morphine hydrochloride which patient will need in first 24 hours postoperative.	in first 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of sensory block.	return of pinbrick sensation on the lateral aspect of the foot (S1)	3, 6, 12, 24 hours postoperative
Duration of motor block.	motor block is tested and recoded every 30 min till Bromage score is zero	3, 6, 12, 24 hours postoperative
Total distance patient will be able to ambulate on first postoperative day	the distance that patient will be able to walk on the first postoperative day (meters)	on first postoperative day
intraoperative non invasive blood pressure(NIBP) mmHg	NIBP will be measured and recorded.	every 10 minutes after spinal anesthesia till the end of the surgery
intraoperative heart rate beat per minute	heart rate will be monitored and recorded.	every 10 minutes after spinal anesthesia till the end of the surgery.
postoperative hypotension mmHg	blood pressure will be measured and recorded	at 1, 3, 6, 12 hours postoperative

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Gehan A Trabeeh, MD, Professor of Anesthesia and Surgical Intensive Care; Study Director: Samah A Gouda, MD, assistant professor of Anesthesia and Surgical Intensive Care; Principal Investigator: Samar A Alattar, M.Sec, Assistant lecturer of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: MFM-IRB: MD. 22.03.629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Yes, Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Supporting Information:
• IPD Sharing Time Frame: after completing the study and being accepted for publication.After six months after completing the study.
• IPD Sharing Access Criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No