Single Shot Versus Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty

NCT04986878 | Completed DMC

• 1 other identifier: 24-10-15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Adductor canal block (ACB) has emerged as an option for postoperative regional analgesia in patients undergoing total knee arthroplasty (TKA).

Conditions

Rheumatism Knee

Outcome Measures

Primary Outcomes (1)

• postoperative pain scores by visual analogue score

  visual analogue score is a straight, vertical 10-cm line with the bottom point representing "no pain" = (0cm) and the top point representing "the worst pain you could ever have" = (10 cm).

  48 hours

Secondary Outcomes (3)

• time to up and go test (minutes)

  48 hours

• six-minute walking test

  48 hours

• the 30-Second Chair test

  48 hours

Study Arms (2)

Single shot adductor canal block

ACTIVE COMPARATOR

Following sterile preparation and draping, an ultrasound survey of the medial thigh was performed, halfway between the superior anterior iliac spine and the patella. The superficial femoral artery has been identified beneath the sartorius muscle in a short-axis view, with the vein just inferior and the saphenous nerve just lateral to the artery. A 20 Gauge, 120 mm, non-cuttings tip echogenic needle (SonoPlex STIM, Germany) needle was introduced in-plane, and 2 to 3 mL of LA bolus (0.25 % Bupivacaine) was used to confirm proper needle placement in the adductor canal near the saphenous nerve. Then, a bolus of 20 ml of Bupivacaine 0.25 % was injected through the needle

Procedure: single-shot adductor canal block

Continuous adductor canal block

ACTIVE COMPARATOR

a catheter was secured in place using Tegaderm. The catheters were connected to a pump that infused local anesthetic, 20 mL of 0.25 % bupivacaine, followed by 48 hours of continuous infusion of 0.125 % bupivacaine at 5 mL/h.

Procedure: single-shot adductor canal block

Interventions

single-shot adductor canal block PROCEDURE

An ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe was used to perform the adductor canal block immediately postoperatively.

Also known as: Saphenous nerve block

Continuous adductor canal block; Single shot adductor canal block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for primary total knee arthroplasty with
• American Society of Anesthesiologists (ASA) physical status I -III,
• mentally competent and able to give consent for enrollment in the study.

You may not qualify if:

• Patient younger than 18 years old or older than 70 years old
• Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol.
• Revision surgeries were excluded.
• Impaired kidney functions and patients with coagulopathy were also excluded.
• Chronic pain syndromes and patients with chronic opioid use defined as the use of regular daily doses of systemic narcotics for the past 6 months prior to the surgery.
• BMI of 40 or more
• Pregnancy (positive urine pregnancy test result in Preop area on the morning of surgery)

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (2)

Aswan University Hospital

Aswān, 81511, Egypt

Location

Huda Fahmy

Aswān, 81511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A computer-generated randomization table will be used for patient allocation to one of the two study groups, The SACB group, and the CACB group. Randomization was done in blocks of 10 patients each. Patients' assignments were written in a sealed envelope that was only open after the patient consents to the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia and Intensive Care

Model Details: The target population of this study will be patients undergoing primary total knee arthroplasty at Aswan l and Assiut university hospitals

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 3, 2021
• Study Start: March 15, 2017
• Primary Completion: March 31, 2018
• Study Completion: June 30, 2018
• Last Updated: August 4, 2021

Record last verified: 2021-08

Locations

EG (2)