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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03395990
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.8
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

An observational study of the effect of femoral nerve block in addition to an adductor canal block for pain following total knee arthroplasty.

Condition or Disease	Intervention/Treatment	Phase
Osteo Arthritis Knee	Procedure: Active comparator: chloroprocaine; Procedure: Sham comparator: saline	N/A

Detailed Description

Subjects undergoing total knee arthroplasty will receive a preoperative adductor canal block with continuous catheter. Following a standardized general anesthetic for the procedure, subjects will be asked to rate their pain using the NRS-11 pain scale in the recovery room. Once the pain is reported at a 5/10 or above, a femoral nerve block will be performed using either 2% chloroprocaine or saline placebo (randomized). Pain scores are then evaluated over the next 30 minutes by a blinded investigator to determine if the femoral block adds any additional analgesic benefit over an adductor canal block.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized, blinded observational studyrandomized, blinded observational study
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: Group allocation by sealed envelope; unblinded investigator prepared syringes of study drug (chloroprocaine vs. saline), which look identical to blinded investigator and assessor.
• Primary Purpose: Treatment
• Official Title: Evaluation of the Comparative Analgesic Value of Adductor Canal Block Versus Femoral Block Following Total Knee Arthroplasty
• Actual Study Start Date: Mar 27, 2016
• Actual Primary Completion Date: Oct 19, 2016
• Actual Study Completion Date: Oct 19, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: chloroprocaine 15 ml of 2% chloroprocaine via a femoral nerve block technique	Procedure: Active comparator: chloroprocaine; 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.; Other Names: femoral nerve block with chloroprocaine
Sham Comparator: saline 15 ml of 0.9% saline via a femoral nerve block technique	Procedure: Sham comparator: saline; 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.; Other Names: femoral nerve block with normal saline

Outcome Measures

Primary Outcome Measures

1. Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. [Baseline, up to 30 minutes.]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 56 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients scheduled for elective total knee arthroplasty

• ASA Physical Status I-III

• BMI 18-40 kg/m2

Exclusion Criteria:

• Inability to cooperate with protocol

• Inability to understand or speak English

• Allergy to any local anesthetic

• Chronic opioid consumption/abuse (30 or more morphine mg equivalents/day)

• Contraindication to adductor canal or femoral nerve block

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Hospital	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Jeff Gadsden, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03395990
• Other Study ID Numbers: PRO00067430
• First Posted: Jan 10, 2018
• Last Update Posted: Jun 17, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Duke University: femoral nerve block; adductor canal block; analgesia
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chloroprocaine; Procaine

Study Results

Participant Flow

Arm/Group Title	Chloroprocaine	Saline
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

Baseline Characteristics

Arm/Group Title	Chloroprocaine	Saline	Total
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 Participants	8	8	16
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	68	68	68
Sex: Female, Male (Count of Participants)
Female	2 25%	6 75%	8 50%
Male	6 75%	2 25%	8 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	8 100%	8 100%	16 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	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%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	8 100%	8 100%	16 100%

Outcome Measures

1. Primary Outcome

Title	Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine	Saline
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.
Measure Participants	8	8
Pre-block	7.0	6.0
5 minutes post-block	4.0	6.0
10 minutes post-block	4.0	6.5
15 minutes post-block	3.2	6.5
20 minutes post-block	3.0	6.0
25 minutes post-block	3.0	5.5
30 minutes post-block	2.0	5.5

Adverse Events

Arm/Group Title	Chloroprocaine		Saline
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Serious Adverse Events
	Chloroprocaine		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Chloroprocaine		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.