Implementation of a Pain Management Protocol for Total Knee Arthroplasty

Health Sciences North Research Institute

Status and phase

Completed

Phase 4

Conditions

Knee Replacement, Total

Treatments

Drug: Fentanyl

Drug: Normal Saline

Drug: Bupivicaine

Drug: Ketorolac

Drug: Epimorphine

Drug: Ropivicaine with Epinephrine

Drug: Epinephrine

Drug: Ropivicaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02474654

15-009

Details and patient eligibility

About

Study question: Is there an ideal combination of intraoperative long acting analgesics (periarticular infiltration (PI), femoral nerve block (FB) and intrathecal opioids (IO)) to optimize post-operative functional recovery, decrease overall narcotic consumption and enable faster 'readiness to discharge' for patients undergoing primary total knee replacement (TKR)?

Full description

Our study design is a five-arm double blinded randomized control trial. In order to create a blinded study, each participant will have all three interventions (Femoral Nerve Block (FB), Periarticular Injection (PI) and Intrathecal Opioid (IO)) performed during their visit. Normal saline (NS) will be substituted for opioid or local anesthetic in cases where a control is required.

Specific 5 arms include:

Using all three anesthetics:

o PI + FB + IO (arm 1)
Using a combination of two anesthetics + normal saline substitute for control:
- NS + FB + IO (arm 2)
- PI + NS + IO (arm 3)
- PI + FB + NS (arm 4)
Control:
- NS + NS + IO (arm 5)

The control arm would include IO as the sole intervention as this is simply added to the spinal anesthetic used for the surgery itself. It is felt that having a study arm without any long-acting analgesic medication (opioid or local anesthetic) as the "control" arm following a spinal anesthetic would not meet current standard of care and cause harm to the participant

The investigators hypothesize that the combination of three forms of long acting analgesia (PI, FB, IO) will result in the greatest outcomes compared to a combination of any two or control. Our aim is to demonstrate that this optimal analgesic combination will have an additive pain control effect and will minimize side effects thus translating to less acute pain, improve patient mobility, and attaining "readiness to discharge" quicker.

Enrollment

220 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years or older
primary total knee replacement for osteoarthritis
agrees to a spinal anesthetic for TKR

Exclusion criteria

History of chronic pain or opioid tolerance (individuals requiring equivalent of 1 mg or more intravenous or 3 mg or more oral morphine per hour for greater than 1 month)
general anesthetic for TKR
major neurological deficit
allergy to local anesthetic
allergy to morphine or hydromorphone, anti-inflammatory, acetaminophen
renal insufficiency
liver failure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

220 participants in 5 patient groups

Arm 1: PI+FNB+IO

Experimental group

Description:

Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg

Treatment:

Drug: Ketorolac

Drug: Fentanyl

Drug: Ropivicaine with Epinephrine

Drug: Epinephrine

Drug: Epimorphine

Drug: Bupivicaine

Drug: Ropivicaine

Arm 2:NS+FNB+IO

Experimental group

Description:

Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml

Treatment:

Drug: Normal Saline

Drug: Fentanyl

Drug: Normal Saline

Drug: Ropivicaine with Epinephrine

Drug: Normal Saline

Drug: Epimorphine

Drug: Bupivicaine

Arm 3: PI+NS+IO

Experimental group

Description:

Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg

Treatment:

Drug: Normal Saline

Drug: Ketorolac

Drug: Fentanyl

Drug: Normal Saline

Drug: Epinephrine

Drug: Normal Saline

Drug: Epimorphine

Drug: Bupivicaine

Drug: Ropivicaine

Arm 4: PI+FNB+NS

Experimental group

Description:

Bupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg

Treatment:

Drug: Normal Saline

Drug: Ketorolac

Drug: Fentanyl

Drug: Normal Saline

Drug: Ropivicaine with Epinephrine

Drug: Epinephrine

Drug: Normal Saline

Drug: Bupivicaine

Drug: Ropivicaine

Arm 5:NS+NS+IO

Active Comparator group