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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01939379
Other study ID # 5130183
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date July 25, 2017

Study information

Verified date April 2021
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.The investigators will be comparing the amount of pain relief following knee replacement surgery when you have a nerve block in place. There will be approximately 66 subjects participating in this study. After surgery subjects will receive numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours around the clock with the option to receive more pain medication if needed. Subjects will participate in the study up to 3 days.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 25, 2017
Est. primary completion date July 25, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: 1. Is the subject undergoing primary unilateral total knee arthroplasty? 2. Is the subject 18 to 99 years of age? 3. Is the subject ASA class 1, 2, or 3? 4. Does the subject have a BMI less than 35? 5. Can the subject consent in the English language? Exclusion Criteria: 1. Does subject have an allergy to drugs used in this study; 2. Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone? 3. Does subject have a history of alcohol or drug abuse 4. Has subject had a previous total knee arthroplasty? 5. Has subject had any neurologic deficits in the lower extremity being studied?

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed.

For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.


Locations

Country Name City State
United States Loma Linda University Medical Center East Campus Hospital Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Opiate pain medication At the end of the 48 hours period the total opiate pain medication taken will be collected and used for comparison as our primary outcome The total amount of opiate pain medication will be recorded at 6 hour intervals for 48 hours after surgery.
Secondary Patient satisfaction with pain control Secondary outcome measures will include demographic characteristics, pain scores, medication administration,patient satisfaction with pain control and any complications that may have arisen. We will also record the location of the adductor canal catheter on the final bolus dose. We will look at the secondary outcome measure beginning every six hours for 48 hours after surgery
See also
  Status Clinical Trial Phase
Completed NCT02244619 - PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement Phase 4
Not yet recruiting NCT02123979 - Study to Assess Dopamine Receptor Modulation With Rotigotine to Enhance Morphine Analgesia in the Dental Model Phase 2