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Analgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395990
Recruitment Status : Completed
First Posted : January 10, 2018
Results First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteo Arthritis Knee
Interventions Procedure: Active comparator: chloroprocaine
Procedure: Sham comparator: saline
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chloroprocaine Saline
Hide Arm/Group Description

15 ml of 2% chloroprocaine via a femoral nerve block technique

Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

15 ml of 0.9% saline via a femoral nerve block technique

Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

Period Title: Overall Study
Started 8 8
Completed 8 8
Not Completed 0 0
Arm/Group Title Chloroprocaine Saline Total
Hide Arm/Group Description

15 ml of 2% chloroprocaine via a femoral nerve block technique

Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

15 ml of 0.9% saline via a femoral nerve block technique

Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
68
(59 to 71)
68
(63 to 73)
68
(61 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
2
  25.0%
6
  75.0%
8
  50.0%
Male
6
  75.0%
2
  25.0%
8
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
8
 100.0%
8
 100.0%
16
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  12.5%
1
  12.5%
2
  12.5%
White
7
  87.5%
7
  87.5%
14
  87.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 16
1.Primary Outcome
Title Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
Hide Description Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable).
Time Frame Baseline, up to 30 minutes.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chloroprocaine Saline
Hide Arm/Group Description:

15 ml of 2% chloroprocaine via a femoral nerve block technique

Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

15 ml of 0.9% saline via a femoral nerve block technique

Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

Overall Number of Participants Analyzed 8 8
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Pre-block
7.0
(5.5 to 8.0)
6.0
(6.0 to 7.5)
5 minutes post-block
4.0
(2.5 to 6.0)
6.0
(5.5 to 7.0)
10 minutes post-block
4.0
(2.0 to 5.0)
6.5
(6.0 to 8.0)
15 minutes post-block
3.2
(2.0 to 4.5)
6.5
(4.5 to 7.0)
20 minutes post-block
3.0
(1.5 to 3.0)
6.0
(4.0 to 7.0)
25 minutes post-block
3.0
(1.5 to 3.0)
5.5
(4.0 to 7.0)
30 minutes post-block
2.0
(1.5 to 2.8)
5.5
(4.0 to 6.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chloroprocaine Saline
Hide Arm/Group Description

15 ml of 2% chloroprocaine via a femoral nerve block technique

Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

15 ml of 0.9% saline via a femoral nerve block technique

Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

All-Cause Mortality
Chloroprocaine Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
Chloroprocaine Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chloroprocaine Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeff Gadsden
Organization: Duke University Medical Center
Phone: 919-681-6437
EMail: jeff.gadsden@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03395990    
Other Study ID Numbers: PRO00067430
First Submitted: December 18, 2017
First Posted: January 10, 2018
Results First Submitted: June 2, 2020
Results First Posted: June 17, 2020
Last Update Posted: June 17, 2020