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Clinical Trials/NCT06423339
NCT06423339CompletedNot Applicable

A Comparative Study Between Ultrasound Guided Genicular Nerve Block Combined With Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee Block Versus Adductor Canal Block in Total Knee Replacement

Ain Shams University1 site in 1 country50 target enrollmentStarted: May 10, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
The primary outcome will be the total postoperative morphine consumption during the first two postoperative days.

Study Overview

Brief Summary

The patients will be randomized into 2 groups, named group A, B.

Group A: The patients will receive Ultrasound guided Genicular nerves block combined with Ultrasound guided IPACK block.

Group B: The patients will receive Adductor canal block which will be the control group.

The Numerical Rating Scale (NRS) will be used to assess pain intensity. Preoperatively, all study subjects will be trained to use NRS pain scores.

The spinal block will be performed.

In group A, 15 mL of bupivacaine 0.25% with 2.5 g/mL adrenaline at a concentration 1:4,00,000 will be administered immediately following skin closure. GNB will be performed by using the linear ultrasound probe (10-15 MHz) Sono site M-turbo ultrasonography to scan the long bone shaft with up and down movement to recognize the epicondyle of the tibia and femur. The junctions between the epicondyle and the shafts of the femur and tibia are where the genicular arteries are located; these junctions will be defined as the periosteal areas. The superior lateral, superior medial and inferior medial genicular arteries accompany each genicular nerve. After confirmation of the genicular artery by color Doppler, the needle will be introduced using the in-plane approach and presented in the long axis view. The target point of the needle insertion will be the needle tip beside a genicular artery. Then, a 5 mL volume will be administered after gentle aspiration to prevent a faulty intra-arterial injection at 3 target locations: the superior lateral, superior medial and inferior medial genicular nerves.

This will be Followed by the procedure for the IPACK block.

In group B, A 22 Gauge 80 mm needle will be guided from lateral to medial to this area called the adductor canal using in-plane technique. 20 mL of 0.5% bupivacaine will be injected with peri-arterial spread after negative aspiration under sterile conditions. TKA will be performed by an orthopedic surgeon by placing three-compartment prostheses with a minimally invasive mini-midvastus approach and using hand-mixed cementing techniques.

Detailed Description

The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B. An independent data manager of computer generated software will be responsible for randomization, assigning the patients to the groups using sequentially numbered, sealed, opaque envelopes containing computer generated random numbers, accessible only to the anesthesiologist performing the block. The subjects will be randomly allocated to one of the two groups.

Group A: The patients will receive Ultrasound guided Genicular nerves block combined with Ultrasound guided IPACK block.

Group B: The patients will receive Adductor canal block which will be the control group.

History taking, clinical examination and routine laboratory investigation will be performed preoperatively, and the patients will be instructed to fast for 8 hours preoperative for solids and 2 hours for clear fluids. On arrival to the operation room, intravenous access will be established and acetated ringer will be infused by rate 10ml/kg. ECG, noninvasive blood pressure and arterial oxygen saturation will be monitored routinely. The Numerical Rating Scale (NRS) will be used to assess pain intensity. Preoperatively, all study subjects will be trained to use NRS pain scores.

In the operating room, a peripheral 20 G intravenous (IV) cannula will be inserted. The baseline parameters of five lead electrocardiogram (ECG), non invasive blood pressure and peripheral oxygen saturation will be recorded. IV midazolam 0.02 mg/kg will be administered. The spinal block will be performed using either a 25 or 27 G spinal needle in the sitting position at the L3-L4 or L4-L5 intervertebral space with a 2.5-3 mL hyperbaric bupivacaine 0.5%. The sensory block (to cold and pinprick) to the 10th thoracic dermatome or above will be the target of the spinal block to start the surgery. Hypotension will be defined as ≥20% decrease in blood pressure from baseline measurements and managed by IV Ephedrine6 mg boluses.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients American Society of anesthesiologists' physical status (ASA) I to III.
  • Aged 40 to 70 years.
  • Both sexes.
  • Patients scheduled for unilateral total knee replacement.

Exclusion Criteria

  • Patients with spinal malformation
  • Patients with liver impairment
  • Patients with renal impairment
  • Patients younger than 40 years or older than 70 years
  • Patients with hypersensitivity to one of the used drugs
  • Patients with neuromuscular disorders and
  • Coagulopathy disorders
  • Patients scheduled for revision knee arthroplasty or those who had a past history of previous surgery or trauma to the knee

Arms & Interventions

Group A

Experimental

Group A will receive genicular nerve block combined with interspace between the popliteal artery and the capsule of the posterior knee block(IPACK)

Intervention: Ultrasound guided Genicular nerve block (Procedure)

Group A

Experimental

Group A will receive genicular nerve block combined with interspace between the popliteal artery and the capsule of the posterior knee block(IPACK)

Intervention: Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior knee (Procedure)

Group A

Experimental

Group A will receive genicular nerve block combined with interspace between the popliteal artery and the capsule of the posterior knee block(IPACK)

Intervention: Bupivacaine Hydrochloride (Drug)

Group B

Experimental

Group B will receive ultrasound guided sub-sartorial Adductor canal block (ACB)

Intervention: Adductor canal block (Procedure)

Group B

Experimental

Group B will receive ultrasound guided sub-sartorial Adductor canal block (ACB)

Intervention: Bupivacaine Hydrochloride (Drug)

Outcomes

Primary Outcomes

The primary outcome will be the total postoperative morphine consumption during the first two postoperative days.

Time Frame: 48 hours

The primary outcome will be the total postoperative morphine consumption during the first two postoperative days.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

riham fathy galal

Lecturer

Ain Shams University

Study Sites (1)

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