Continuous Adductor Canal Blocks Vs. Low Dose Femoral Nerve Blocks For Early Rehabilitation After Total Knee Arthroplasty

NCT02453321 | Completed Phase 4 Results

• 1 other identifier: PRO13110481
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, several articles have suggested or reported that Adductor Canal Blocks (ACBs) offer adequate or equal analgesia and may promote better performance in early rehabilitation following Total Knee Arthroplasty (TKA) when compared to the more commonly used Femoral Nerve Block (FNB). A common feature of these studies has been the use of moderate to high concentration local anesthetics (e.g. 0.2% or 0.5% Ropivacaine respectively) which when injected by a large motor nerve will inevitably cause weakness. However, the practice at our institution has long been a continuous femoral nerve block (CFNB) with a lower concentration local anesthetic (0.0625% Bupivacaine). Over the past several years the investigators have performed several thousand CFNBs using this technique which has offered the advantage of minimal motor weakness and adequate analgesia. The primary goal of this study is to determine if our established practice of using a low concentration continuous FNB inserted about 5cm caudal to the groin crease (the apex of the femoral triangle) using a low infusion rate of 2ml/hr is comparable to the emerging practice of inserting a Continuous Peripheral Nerve Block (CPNB) in the anatomic adductor canal (AC) - infusing at 4ml/hr. A secondary goal is to study the effect of cumulative volume of local anesthetic infused through a FNB when at a rate of 2ml/hr compared to a rate of 4ml/hr in the 48-hour postoperative period. Definitions of the location of the adductor canal are debated heavily in literature, but they seem to agree that the middle 1/3 of the thigh contains the proximal AC while the distal 1/3 of the thigh contains the adductor hiatus - the terminal end of the AC. Our study will require placement of the continuous ACB no more distal than 20cm cephalad to the superior pole of the patella due to placement prior to surgery and the need to keep the dressing out of the operative field. The CACB catheter will also not be placed any more proximal than 20cm distal to the ASIS. In addition to other exclusion criteria, these measurements will create an exclusion for patients with an iliac-to-patella distance less than 40cm. Iliac to Patella distance (IPD) will be measured at the pre-operative interview on the day of surgery with a measuring tape. External palpable landmarks of the Anterior superior iliac spine and the superior pole of the patella will be used. The primary outcome is based upon the ability to perform rehabilitation exercises postoperatively to the extent that criteria for discharge can be met. The primary outcome measured is the time at which a patient gains the ability to successfully perform a 75-feet unassisted walk. On the Day of Surgery (DOS), prior to any walking attempt, a secondary outcome measure will be to perform a 5-second sustained straight leg raise. Other secondary outcomes will be the number of days admitted prior to discharge, and average pain scores on DOS, Postoperative Day (POD) #1, and POD#2. The Day of discharge will also be used as a secondary outcome. Earlier discharge is becoming a goal of almost all healthcare systems to minimize costs.

Conditions

Pain, Postoperative; Total Knee Arthroplasty (TKA)

Keywords

Continuous Femoral Nerve Block; Continuous Adductor Canal Block

Outcome Measures

Primary Outcomes (1)

• Time to Achieve Physical Therapy Discharge Criteria as Measured by 75-feet Walk Test. {Number of Hours After Conclusion of Surgery}

  Ability to walk 75 feet if performed on POD#2 is usually considered the main criterion for discharge at UPMC Passavant. The patient is accompanied/supervised by physical therapist using a walker but without active intervention by therapist, unless necessary. The earliest day on which the patient achieves the 75-feet unassisted walk will be recorded for comparison among the arms/groups.

  Participants will be followed for the duration of hospital stay, an average of 4 days

Secondary Outcomes (3)

• Average Length of Stay (to be Reported in Hours After Surgery)

  Participants will be followed for the duration of hospital stay; No patients will be discharged on the day of surgery; The earliest discharge would be at 24 hours. Those hospitalized beyond 96 hours will be excluded.

• Postoperative Pain, Average Reported Score 11-point Scale

  postoperative day one

• Sustained Straight Leg Raise

  Day of Surgery (DOS) - In Postoperative Recovery Unit, prior to any walking atempt

Study Arms (3)

Cont. Femoral Block - Low Dose Group

ACTIVE COMPARATOR

Arm is named by the intervention the group receives. Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.

Procedure: Continuous Femoral Nerve Block; Procedure: Continuous Sciatic Nerve Block; Drug: Bupivacaine

Cont. Femoral Block - Higher Dose

EXPERIMENTAL

Place the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy

Procedure: Continuous Femoral Nerve Block; Procedure: Continuous Sciatic Nerve Block; Drug: Bupivacaine

Continuous Adductor Canal

EXPERIMENTAL

Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.

Procedure: Nerve Block, Continuous Adductor Canal; Procedure: Continuous Sciatic Nerve Block; Drug: Bupivacaine

Interventions

Continuous Femoral Nerve Block PROCEDURE

A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty

Also known as: Continuous Nerve Block, Femoral, Continuous Peripheral Nerve Block

Cont. Femoral Block - Higher Dose; Cont. Femoral Block - Low Dose Group

Nerve Block, Continuous Adductor Canal PROCEDURE

A 27g plastic catheter placed on the anterior medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty

Also known as: Continuous Nerve Block, Adductor Canal, Continuous Peripheral Nerve Block, Adductor Canal

Continuous Adductor Canal

Continuous Sciatic Nerve Block PROCEDURE

A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.

Also known as: Nerve Block, Sciatic Continuous

Cont. Femoral Block - Higher Dose; Cont. Femoral Block - Low Dose Group; Continuous Adductor Canal

Bupivacaine DRUG

The concentration of the continuous infusion of bupivacaine though the peripheral nerve catheters will be 0.0625% for the femoral and adductor canal blocks and the concentration for the sciatic continuous catheter will be 0.03%.

Cont. Femoral Block - Higher Dose; Cont. Femoral Block - Low Dose Group; Continuous Adductor Canal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to consent to regional anesthesia and having primary total knee arthroplasty/replacement

You may not qualify if:

• Body-Mass Index \>40
• Iliac to Patella Distance (IPD) \<40cm
• Pre-existing quadriceps weakness of involved surgical side Chronic opioid use (if using opioids within 4 weeks of surgery: excluded)

Sponsors & Collaborators

• Kevin King, DO: lead

Study Sites (1)

University of Pittsburgh Medical Center - Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Nerve Block; Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Kevin King, DO - Clinical Asst. Professor
• Organization: University of Pittsburgh Medical Center

kingkk@upmc.edu

412 748-5589

Study Officials

• Waters Jonathan, MD

  University of Pittsburgh

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 25, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 31, 2016
• Last Updated: March 27, 2018
• Results First Posted: March 27, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)