Adductor Canal Nerve Block Following Total Knee Arthroplasty

NCT01939379 | Withdrawn

• 1 other identifier: 5130183
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-op Pain

Keywords

Total knee arthroplasty; nerve block; Pain control after surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient satisfaction with pain control

  We will look at the secondary outcome measure beginning every six hours for 48 hours after surgery

Study Arms (2)

15ml ropivacaine

ACTIVE COMPARATOR

Depending on what dose of ropivacaine the subject is randomized to he/she could receive the 15ml dose injected into the catheter every 6 hours

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

30ml ropivacaine

ACTIVE COMPARATOR

If the subject is randomized to 30ml ropivacaine he/she will be injected through the catheter every 6 hours.

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

Interventions

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

15ml ropivacaine

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

30ml ropivacaine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is the subject undergoing primary unilateral total knee arthroplasty?
• Is the subject 18 to 99 years of age?
• Is the subject ASA class 1, 2, or 3?
• Does the subject have a BMI less than 35?
• Can the subject consent in the English language?

You may not qualify if:

• Does subject have an allergy to drugs used in this study;
• Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone?
• Does subject have a history of alcohol or drug abuse
• Has subject had a previous total knee arthroplasty?
• Has subject had any neurologic deficits in the lower extremity being studied?

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center East Campus Hospital

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 11, 2013
• Study Start: September 1, 2013
• Primary Completion: July 25, 2017
• Study Completion: July 25, 2017
• Last Updated: April 20, 2021

Record last verified: 2021-04

Locations

US (1)