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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03395990
Other study ID # PRO00067430
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 27, 2016
Est. completion date October 19, 2016

Study information

Verified date June 2020
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date October 19, 2016
Est. primary completion date October 19, 2016
Accepts healthy volunteers No
Gender All
Age group 56 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Duke University Hospital Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. 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). Baseline, up to 30 minutes.
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