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

Primary Purpose

Rheumatism Knee

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
single-shot adductor canal block
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatism Knee

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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:

  1. Patient younger than 18 years old or older than 70 years old
  2. Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol.
  3. Revision surgeries were excluded.
  4. Impaired kidney functions and patients with coagulopathy were also excluded.
  5. 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.
  6. BMI of 40 or more
  7. Pregnancy (positive urine pregnancy test result in Preop area on the morning of surgery)

Sites / Locations

  • Aswan University Hospital
  • Huda Fahmy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single shot adductor canal block

Continuous adductor canal block

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

time to up and go test (minutes)
determines how long it takes a person to get out of a chair
six-minute walking test
calculates the distance that can be walked in 6 minutes
the 30-Second Chair test
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

Full Information

First Posted
June 30, 2021
Last Updated
August 3, 2021
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04986878
Brief Title
Single Shot Versus Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty
Official Title
Comparison Between the Analgesic Effects of Single Shot Versus Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatism Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The 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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single shot adductor canal block
Arm Type
Active Comparator
Arm Description
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
Arm Title
Continuous adductor canal block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
single-shot adductor canal block
Other Intervention Name(s)
Saphenous nerve block
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative pain scores by visual analogue score
Description
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).
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
time to up and go test (minutes)
Description
determines how long it takes a person to get out of a chair
Time Frame
48 hours
Title
six-minute walking test
Description
calculates the distance that can be walked in 6 minutes
Time Frame
48 hours
Title
the 30-Second Chair test
Description
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
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81511
Country
Egypt
Facility Name
Huda Fahmy
City
Aswan
ZIP/Postal Code
81511
Country
Egypt

12. IPD Sharing Statement

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

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