Impact of Adductor Canal Block on Functional Recovery

Total Knee Replacement Clinical Trial

Official title:

Adductor Canal Block Versus Periarticular Infiltration Effect on Functional Outcome In Patients Undergoing Total Knee Replacement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04814303
• Other study ID #: Adductor canal block in TKR
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: August 2022

Study information

• Verified date: March 2021
• Source: Assiut University
• Contact: Shimaa A Hassan, M.D.
• Phone: 01002953253
• Email: shimaa.abbas[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TKA involves extensive bone resection as well as soft tissue excision and therefore is associated with profound postoperative pain. Adequate analgesia after TKA is therefore considered paramount to facilitate early hospital discharge and effective functional recovery.

Description:

Osteoarthritis (OA) of the knee has become a major public health issue and imposes a significant healthcare burden and accounts for high annual hospitalizations. Chronic OA of the knee may lead to reduced physical fitness, mobility disability with a resultant increased risk of cardio-metabolic comorbidity and early mortality. Total knee arthroplasty (TKA) is indicated in severe cases to improve long-term pain and function. (1) TKA involves extensive bone resection as well as soft tissue excision and therefore is associated with profound postoperative pain. (2) Inadequate perioperative pain control may prolong hospitalization, hinder early rehabilitation, and is also a strong predictor of persistent pain beyond 3 months. (3) Adequate analgesia after TKA is therefore considered paramount to facilitate early hospital discharge and effective functional recovery. (4) The recently introduced adductor canal block (ACB) typically covers the anterio-medial aspect of the knee and preserves quadriceps function, which presumably enhances postoperative rehabilitation by allowing patients to actively participate in knee movement. The relative effectiveness of this ACB technique added to intrathecal morphine is limited to a single study (1) in which assessment of short-term functional recovery was done and dexamethasone was neither included in the LIA solution nor perineurally in the ACB. Thus, we hypothesize that adductor canal block as an adjunct to intrathecal morphine will have a better impact on functional recovery than peri-articular infiltration.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologist class ( ASA) I - III

• BMI 18-35 kg/m2

• Scheduled for primary unilateral TKR

Exclusion Criteria:

• Known allergy to local anesthetics

• Contraindication to adductor canal block e.g. infection at the site of injection

• Contraindication to spinal anesthesia e.g. coagulopathy.

• Patients with pre-existing motor or sensory deficits in lower extremities.

• Patients who are morbidly obese (BMI=35) because ultrasound-guided regional anesthesia could be technically difficult.

• Bilateral or revision total knee replacement

• Insulin or noninsulin-dependent diabetes mellitus.

• systemic corticosteroid use within 30-days of surgery

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Procedure:
• Intrathecal morphine
After applying standard monitoring of pulse oximetry, ECG, NIBP; while the patient in the sitting position following complete sterile aseptic condition after sterilization bovine bethidine spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral levels using a 25- gauge Whitacre needle. Intrathecal morphine 150 µg will be added to patients of both groups. Supplemental oxygen will be administered via a simple face mask.
• Adductor Canal block
The block will be performed in the mid adductor canal to block both the saphenous and the nerve to vastus medialis. After skin infiltration with 1 to 2 mL of 2% lidocaine, an 80-mm, 22-gauge, short-bevel echogenic needle is advanced in plane with the ultrasound beam in an anterior-to-posterior direction until the tip is located within the adductor canal deep to the vastoadductor membrane. After negative aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection plane. The study solution will be injected within the canal adjacent to the femoral artery. Patients in group 1 received 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine and 4 mg dexamethasone.
• Peri-articular Infilteration
the surgeon will perform the PAI intra-operatively; 150 mL of 0.25% bupivacaine with 1:400,000 epinephrine, 30 mg of ketorolac, and 8 mg dexamethasone. Half of the solution will be administered into the posterior capsule and posterior soft tissues of the knee under direct vision after osteotomy but before insertion of the implants. The remaining half of the solution will be administered into the anterior soft tissues after placement of the implants and before skin closure. All local infiltration will be carried out while a thigh tourniquet (used to limit surgical bleeding) was inflated at a pressure of 300 to 350 mm Hg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Timed Up and Go" test (TUG)	reflects the time it takes a subject to stand up from a standard-height armchair, walk 3 m, walk back to the chair, and sit down.	48 hours
Secondary	Visual analogue scale (VAS) at rest	will be used to assess knee pain intensity	72 hours
Secondary	Visual analogue scale (VAS) at movement	will be used to assess knee pain intensity	72 hours
Secondary	Time to first analgesic request	the first time the patient ask for analgesia	72 hours
Secondary	Total analgesic consumption	Total consumption of postoperative rescue analgesics (total of paracetamol doses) will be recorded	72 hours