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

Sponsor

Aswan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04986878

Collaborator

(none)

Enrollment

Locations

Arms

15.5

Actual Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatism Knee	Procedure: single-shot adductor canal block	N/A

Detailed Description

Various approaches to the performance of peripheral nerve blocks for postoperative pain control in patients undergoing TKA have been described in the literature. These approaches include lumbar plexus block, femoral nerve block (FNB), with or without a sciatic nerve block, and most recently the ACB. FNB is a commonly used modality for postoperative analgesia after TKA. It is considered by some as the gold standard or the cornerstone of postoperative analgesia after TKA. However, FNB reduces quadriceps muscle strength essential for mobilization and active contribution in any physical rehabilitation program. Quadriceps weakness places the patients at risk of falling. which may be detrimental to postoperative recovery. The ACB has recently emerged as an appealing alternative to FNB as it is predominately a sensory nerve block of a more distal branch of the femoral nerve ( the saphenous nerve).

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Comparison Between the Analgesic Effects of Single Shot Versus Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty

Actual Study Start Date :

Mar 15, 2017

Actual Primary Completion Date :

Mar 31, 2018

Actual Study Completion Date :

Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single shot adductor canal block 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 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. Other Names: Saphenous nerve block
Active Comparator: Continuous adductor canal block 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 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. Other Names: Saphenous nerve block

Arm

Intervention/Treatment

Active Comparator: Single shot adductor canal block

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

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.

Other Names:

Saphenous nerve block

Active Comparator: Continuous adductor canal block

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

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.

Other Names:

Saphenous nerve block

Outcome Measures

Primary Outcome Measures

postoperative pain scores by visual analogue score [48 hours]
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).

Secondary Outcome Measures

time to up and go test (minutes) [48 hours]
determines how long it takes a person to get out of a chair
six-minute walking test [48 hours]
calculates the distance that can be walked in 6 minutes
the 30-Second Chair test [48 hours]
determines how many times a person can rise from a chair and sit down again in 30 seconds while keeping their arms crossed over their chest

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University Hospital	Aswan		Egypt	81511
2	Huda Fahmy	Aswan		Egypt	81511

Sponsors and Collaborators

Aswan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huda Fahmy Mahmoud, PhD, Assistant professor of Anesthesia and Intensive Care, Aswan University Hospital

ClinicalTrials.gov Identifier:

NCT04986878

Other Study ID Numbers:

24-10-15

First Posted:

Aug 3, 2021

Last Update Posted:

Aug 4, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rheumatic Diseases

Study Results

No Results Posted as of Aug 4, 2021