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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05447871
• Other study ID #: MFM-IRB: MD. 22.03.629
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: July 2023

Study information

• Verified date: July 2022
• Source: Mansoura University
• Contact: Gehan A Trabeeh, MD
• Phone: 00201061618512
• Email: gehan_tarbeeh2011[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

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.
• 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.

Drug:
• Bupivacaine 0.25%
bupivacaine 0.25%

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of sensory block.	return of pinbrick sensation on the lateral aspect of the foot (S1)	3, 6, 12, 24 hours postoperative
Secondary	Duration of motor block.	motor block is tested and recoded every 30 min till Bromage score is zero	3, 6, 12, 24 hours postoperative
Secondary	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
Secondary	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
Secondary	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.
Secondary	postoperative hypotension mmHg	blood pressure will be measured and recorded	at 1, 3, 6, 12 hours postoperative