Impact of Adductor Canal Block on Functional Recovery

NCT04814303 | Unknown

• 1 other identifier: Adductor canal block in TKR
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• "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 Outcomes (4)

• Visual analogue scale (VAS) at rest

  72 hours

• Visual analogue scale (VAS) at movement

  72 hours

• Time to first analgesic request

  72 hours

• Total analgesic consumption

  72 hours

Study Arms (3)

ITM

ACTIVE COMPARATOR

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 and Intrathecal morphine 150 μg will be added.

Procedure: Intrathecal morphine

ACB

ACTIVE COMPARATOR

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 and Intrathecal morphine 150 μg will be added. 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, the 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 this group received 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine and 4 mg dexamethasone.

Procedure: Intrathecal morphine; Procedure: Adductor Canal block

PAI

ACTIVE COMPARATOR

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 and Intrathecal morphine 150 μg will be added. PAI intra-operatively will be performed with 150 mL of 0.25% bupivacaine with 1:400,000 epinephrine, 30 mg of ketorolac, and 8 mg dexamethasone.

Procedure: Intrathecal morphine; Procedure: Peri-articular Infilteration

Interventions

Intrathecal morphine PROCEDURE

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.

ACB; ITM; PAI

Adductor Canal block PROCEDURE

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.

ACB

Peri-articular Infilteration PROCEDURE

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.

PAI

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologist class ( ASA) I - III
• BMI 18-35 kg/m2
• Scheduled for primary unilateral TKR

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Central Study Contacts

Shimaa A Hassan, M.D.

CONTACT

01002953253; shimaa.abbas@med.aun.edu.eg

Amira M Gad, M.B.B.CH

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lectrure of Anesthesia

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 24, 2021

Record last verified: 2021-03