Pain Control After Total Knee Arthroplasty: Benefit In Adding Single Shot Adductor Canal Block to Existing Pain Regimen Protocol?

Pain Clinical Trial

Official title:

Pain Control After Total Knee Arthroplasty: A Prospective, Double-blind Randomized Controlled Trial Examining the Benefit of a Combined Adductor-canal Nerve Block With Periarticular Infiltration Versus Periarticular Injection Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02740192
• Other study ID #: 10221
• Status: Completed
• Phase: Early Phase 1
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring total knee arthroplasty will be eligible. The study compares pain control, opioid consumption, and physical exam findings in patients undergoing total knee arthroplasty between patients receiving adductor canal block and those who receiving periarticular injection alone.

Description:

The purpose of this project is to compare the effectiveness of two different but well accepted approaches to nerve blockade in order to improve pain control after total knee arthroplasty. Specifically, this study seeks to identify the if adductor canal blockade provides additional pain relief and decreased morphine consumption when used in addition to a local infiltration of anesthetic (periarticular injection).

Aims:

1. compare pain scores in the post operative period between the two groups.

2. compare morphine equivalent required in the postoperative period

3. compare patient satisfaction with pain control in the post operative period

4. compare physical exam findings such as joint range of motion in the post operative period

5. compare ability to participate with physical therapy in the post operative period

Total knee arthroplasty is associated with intense pain in the post operative period. Pain control is essential in this patient population. Beyond the ethical and humanitarian concerns, pain has been shown in the literature to affect outcomes after total knee replacement. Patients in pain tend to have worse range of motion, decreased participation with physical therapy, increased time to discharge, and downstream medical sequela as well. Pain has been shown to cause or exacerbate delirium in the postoperative period. Patients in pain ambulate less and stay in bed more, therefore increasing the risk of deep vein thrombosis and pulmonary embolism. Patients in pain consume more opioids, which have well known side effects, such as constipation, nausea, vomiting, pruritus, addiction, and altered mental status. Early joint range of motion prevents irreversible joint stiffness and pain, affecting long term outcomes. Pain control in patients undergoing total knee arthroplasty has improved in recent years. The current standard has become a multimodal approach, consisting of preoperative, intraoperative and post operative interventions. The multimodal approach works by preventing or addressing pain at multiple location and targets multiple different pain receptors and pain generators. There has been much attention given to injections and nerve blocks in addition to standard pain medications such as antiinflammatories, acetaminophen, and opioids. There have been many published studies investigating various medication regimens, periarticular injection cocktails, and post operative nerve blocks. These studies have shown that each modality works better than placebo. Several studies have shown that post operative blocks provide additional benefit when used in conjunction with a periarticular injection. These studies were done with femoral nerve catheters and adductor canal catheters that stay in place for several days post operative and require subsequent boluses. No studies in the literature have studied the additional benefit of a single shot adductor canal block. The rationale is that the injection given at the time of surgery should affect the same same local nerves and pain receptors as the adductor canal block, via a different technique. Therefore, the investigators believe the adductor canal block may prove to be of no additional benefit in the investigators patients.

The ultimate goal is identifying the best pain control protocol to decrease pain in the post operative period. Developing this protocol may require the addition or subtraction of various treatment modalities. This study is looking at the adductor canal block, which if found to be unnecessary will prevent patients from receiving unnecessary procedures. If found to be effective at reducing pain, then this study will provide direct evidence for using single shot adductor canal blockade in addition to the periarticular injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over the age of 18 scheduled for primary total knee arthroplasty by four fellowship trained surgeons will be eligible for inclusion.

Exclusion Criteria:

• Patients will be excluded if their medical history presents chronic opioid use (greater than 3 month use),

• pregnancy,

• history of intolerance to medications in the study, and substantial substance abuse.

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Adductor Canal Block
Post-op adductor canal block using Bupivacaine
• Periarticular Injection
Intra-op periarticular injection of Ropivacaine

Drug:
• Ropivacaine
Ropivacaine was used for the periarticular injection
• Bupivacaine
Bupivacaine was used for the periarticular injection

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain level (Visual Analog Scale)	Patients' pain levels will be recorded every 6 hours using VAS (Visual Analog Scale) by the nursing staff from when the patient arrives on the inpatient floor to when the patient is discharged from the hospital.	Through study completion, an average of 3 days
Primary	Knee flexion and extension Range of Motion (ROM)	Patients' knee ROM will be assessed every morning at 6:30am by the rounding physician on the inpatient floor until the patient is discharged from the hospital.	Through study completion, an average of 3 days
Primary	Distance Walked (meters)	Patients will work with Physical Therapists 2 times day (AM and PM). Distance walked (meters) will be recorded by the Physical Therapist from postoperative day #1 until the patient is discharged from the hospital.	Through study completion, an average of 3 days
Primary	Pain with Ambulation (VAS)	Patients will work with Physical Therapists 2 times day (AM and PM). Pain with ambulation (VAS) will be recorded by the Physical Therapist from postoperative day #1 until the patient is discharged from the hospital.	Through study completion, an average of 3 days
Secondary	Pain Medication Intake	Patients' opioid intake (oxycodone, morphine, ms contin, dilaudid, etc) will be calculated and converted to morphine equivalents. The values will be recorded by the rounding physician from when the patient arrives on the inpatient floor to when the patient is discharged from the hospital.	Through study completion, an average of 3 days
Secondary	Time to discharge readiness	Time to discharge readiness will be calculated in hours by the rounding physician from when the patient arrives on the inpatient floor to when the patient is discharged from the hospital.	Through study completion, an average of 3 days