Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee

Unilateral Knee Arthroplasty Clinical Trial

— IVAM  

Official title:

Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee Arthroplasty (TKA). Prospective, Randomized, Open-label Trial to Determine if Switching From Oral to Intravenous Acetaminophen and Orphenadrine for 48 Hours After TKA Improves Outcomes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449369
• Other study ID #: 521770
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2015
• Last updated: August 29, 2017
• Start date: April 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2017
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Hypotonia
• Unilateral Knee Arthroplasty

Intervention

Drug:
• Preop acetaminophen IV

• Preop orphenadrine IV

• Postop oral oxycodone & acetaminophen

• Postop hydromorphone IV

• Postop oral orphenadrine

• Postop oral oxycodone

• Postop acetaminophen IV

• Postop orphenadrine IV

Locations

Country	Name	City	State
United States	Florida Hospital Winter Park	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida Hospital	Sagent Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (11)

Gombotz H, Lochner R, Sigl R, Blasl J, Herzer G, Trimmel H. Opiate sparing effect of fixed combination of diclophenac and orphenadrine after unilateral total hip arthroplasty: A double-blind, randomized, placebo-controlled, multi-centre clinical trial. Wi — View Citation

Hidalgo DA, Pusic AL. The role of methocarbamol and intercostal nerve blocks for pain management in breast augmentation. Aesthet Surg J. 2005 Nov-Dec;25(6):571-5. doi: 10.1016/j.asj.2005.09.003. — View Citation

Korkmaz Dilmen O, Tunali Y, Cakmakkaya OS, Yentur E, Tutuncu AC, Tureci E, Bahar M. Efficacy of intravenous paracetamol, metamizol and lornoxicam on postoperative pain and morphine consumption after lumbar disc surgery. Eur J Anaesthesiol. 2010 May;27(5): — View Citation

Looke TD, Kluth CT. Effect of preoperative intravenous methocarbamol and intravenous acetaminophen on opioid use after primary total hip and knee replacement. Orthopedics. 2013 Feb;36(2 Suppl):25-32. doi: 10.3928/01477447-20130122-54. — View Citation

Málek J, Nedelová I, Lopourová M, Stefan M, Kostál R. [Diclofenac 75mg. and 30 mg. orfenadine (Neodolpasse) versus placebo and piroxicam in postoperative analgesia after arthroscopy]. Acta Chir Orthop Traumatol Cech. 2004;71(2):80-3. Czech. — View Citation

Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2. — View Citation

Schneider MS. Methocarbamol: adjunct therapy for pain management in breast augmentation. Aesthet Surg J. 2002 Jul;22(4):380-1. doi: 10.1067/maj.2002.126750. — View Citation

Schneider MS. Pain reduction in breast augmentation using methocarbamol. Aesthetic Plast Surg. 1997 Jan-Feb;21(1):23-4. — View Citation

Sinatra RS, Jahr JS, Reynolds L, Groudine SB, Royal MA, Breitmeyer JB, Viscusi ER. Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis. Pain Pract. 2012 Jun;12(5):357-65. doi: 10.1111/j.1533-2500.2011.00514.x. Epub 2011 — View Citation

Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesth — View Citation

Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Routine Pain Intensity Scores	verbal subjective assessment by patient reported to nursing at standard assessment times as an ordinal number between 0 and 10 (inclusive) where 0 is no pain and 10 is the maximum pain imaginable	48 hours
Primary	Abbreviated Pain Intensity Scores	Verbal subjective assessment by patient reported to nursing at standard assessment times as either "mild", "moderate", or "severe".	48 hours
Primary	Opioid Consumption,	recorded by nursing with dose and time. Cumulative and total opioid consumption will be analyzed.	48 hours
Primary	Physical therapy metrics/goals	measured and recorded by physical therapist in daily chart notes quantifying ability to get out of bed, range of motion (in flexion/extension degrees) and average and maximum ambulation (in feet) during postoperative days 0 to 2.	48 hours
Secondary	PACU discharge	Time to discharge from the PACU will be measured from PACU arrival to time of PACU discharge criteria met in minutes.	48 hours
Secondary	Hospital Discharge	Time to discharge from the hospital will be measured from time/date of surgical incision to time/date that hospital discharge criteria is met, measured in hours.	48 hours
Secondary	Patient satisfaction	19 point validated questionnaire of perioperative satisfaction with items for regional anesthesia	48 hours
Secondary	Cost as measured by	study medication acquisition cost reported by pharmacy, study medication administration cost reported by pharmacy and nursing, length of stay cost reported by hospital accounting.	48 hours