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

NCT05447871 | Unknown DMC

• 1 other identifier: MFM-IRB: MD. 22.03.629
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of sensory block.

  3, 6, 12, 24 hours postoperative

• Duration of motor block.

  3, 6, 12, 24 hours postoperative

• Total distance patient will be able to ambulate on first postoperative day

  on first postoperative day

• intraoperative non invasive blood pressure(NIBP) mmHg

  every 10 minutes after spinal anesthesia till the end of the surgery

• intraoperative heart rate beat per minute

  every 10 minutes after spinal anesthesia till the end of the surgery.

Study Arms (2)

Ultrasound guided single injection modified 4 in 1 block technique

EXPERIMENTAL

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; Drug: Bupivacaine 0.25%

Ultrasound guided adductor canal block technique

ACTIVE COMPARATOR

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

Procedure: Ultrasound guided adductor canal block technique; Drug: Bupivacaine 0.25%

Interventions

Ultrasound guided single injection modified 4 in 1 block technique 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.

Ultrasound guided single injection modified 4 in 1 block technique

Ultrasound guided adductor canal block technique 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.

Ultrasound guided adductor canal block technique

Bupivacaine 0.25% DRUG

bupivacaine 0.25%

Ultrasound guided adductor canal block technique; Ultrasound guided single injection modified 4 in 1 block technique

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

Study Officials

• Gehan A Trabeeh, MD

  Professor of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

• Samah A Gouda, MD

  Assistant Professor of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

• Samar A Alattar, M.Sec

  Assistant lecturer of Anesthesia and Surgical Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gehan A Trabeeh, MD

CONTACT

00201061618512; gehan_tarbeeh2011@hotmail.com

Samah A Gouda, MD

CONTACT

00201002262557; Sk_20022000@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind (participant) study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 7, 2022
• Study Start: July 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after completing the study and being accepted for publication.After six months after completing the study.
• Access Criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients.

Locations

EG (1)