Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee (IVAM)

AdventHealth

Status and phase: Completed; Phase 4

Conditions: Unilateral Knee Arthroplasty

Treatments: Drug: Postop orphenadrine IV; Drug: Preop acetaminophen IV; Drug: Postop acetaminophen IV; Drug: Postop oral orphenadrine; Drug: Postop hydromorphone IV; Drug: Postop oral oxycodone & acetaminophen; Drug: Preop orphenadrine IV; Drug: Postop oral oxycodone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02449369

521770

Details and patient eligibility

About

This is a prospective, three-arm, randomized, open-label trial to determine if a new pain control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces average pain scores.

Full description

This research will be a prospective, three-arm, randomized, open-label trial to assess opioid use and patient reported outcomes after 48 hours of regular IV acetaminophen and muscle relaxant (IVAM) orphenadrine administration following total knee replacement surgery. 180 patients (60 in each arm) will be randomized to receive the standard group treatment, the IVAM group treatment, or to the control grouptreatment.

Standard Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours) as requested by the surgeon; preoperative (single dose) intravenous acetaminophen (1000 mg) and orphenadrine (60 mg); intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; postoperative oral oxycodone (5 mg) with acetaminophen (325 mg) (PRN dosing), oral orphenadrine (100 mg) every 12 hours for 3 doses, and intravenous hydromorphone (PRN dosing) for breakthrough pain.

Control Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours); preoperative (single dose) intravenous acetaminophen (1000 mg) intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; and postoperative oral oxycodone and acetaminophen (PRN dosing), and intravenous hydromorphone (PRN dosing) for breakthrough pain.

IVAM Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours); preoperative intravenous acetaminophen (1000 mg) and orphenadrine (60 mg); intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; postoperative intravenous acetaminophen (1000 mg) every 6 hours routine for total of 8 doses and intravenous orphenadrine (60 mg) every 12 hours for total of 4 doses; oral oxycodone (5 mg) (PRN dosing), and intravenous hydromorphone (PRN dosing) for breakthrough pain.

Enrollment: 180 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18-85
2. Primary, unilateral total knee arthroplasty
3. American Society of Anesthesiologist (ASA) physical status I, II, or III

Exclusion criteria

1. Chronic pain (as determined by regular opioid use in the month preceding surgery)
2. Preoperative use of centrally acting muscle relaxants in the 24 hours preceding surgery
3. Peripheral regional anesthesia procedures other than femoral nerve injections or catheters for postoperative pain control (such as popliteal block)
4. Severe renal dysfunction, creatinine > 2.0
5. Allergy or other contraindications to use of orphenadrine and/or acetaminophen
6. Pregnant or breast feeding
7. Abnormal Liver Function Tests(LFT) and / or history of chronic/excessive alcohol abuse.
8. History of Hepatitis, B or C,
9. History of cirrhosis or hepatic insufficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 3 patient groups

Control

Active Comparator group

Description:

Preop acetaminophen IV 1000 mg, Postop oral oxycodone \& acetaminophen (5/325 mg) 1 to 2 tabs every 4 hours PRN, and Postop hydromorphone IV 0.5 mg every 4 hours PRN

Treatment:

Drug: Postop oral oxycodone & acetaminophen

Drug: Postop hydromorphone IV

Drug: Preop acetaminophen IV

Standard

Active Comparator group

Description:

Preop acetaminophen IV 1000 mg, Preop orphenadrine IV 60 mg, Postop oral orphenadrine 100 mg every 12 hours for 3 doses, Postop oral oxycodone \& acetaminophen (5/325 mg) 1 to 2 tabs every 4 hours PRN, Postop hydromorphone IV 0.5 mg every 4 hours PRN

Treatment:

Drug: Preop orphenadrine IV

Drug: Postop oral oxycodone & acetaminophen

Drug: Postop hydromorphone IV

Drug: Postop oral orphenadrine

Drug: Preop acetaminophen IV

IVAM

Experimental group

Description:

Preop acetaminophen IV 1000 mg, Preop orphenadrine IV 60 mg, Postop acetaminophen IV 1000 mg every 6 hours for 7 doses, Postop orphenadrine IV 60 mg every 12 hours for 3 doses, Postop oral oxycodone 5 mg 1 to 2 tabs every 4 hours PRN, Postop hydromorphone IV 0.5 mg every 4 hours PRN

Treatment:

Drug: Postop oral oxycodone

Drug: Preop orphenadrine IV

Drug: Postop hydromorphone IV

Drug: Postop acetaminophen IV

Drug: Preop acetaminophen IV

Drug: Postop orphenadrine IV