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Efficacy of Adrenaline in Periarticular Analgesic Injection on Postoperative Pain Control After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03549221
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Chaturong Pornrattanamaneewong, Mahidol University

Brief Summary:
Multimodal anesthetic drug injection has been used extensively and the results of many studies suggest that postoperative pain can relief and improve the postoperative satisfaction of patients. Adrenaline is a combination of multimodal anesthetic cocktail to relieve pain. It is believed that Adrenaline causes vasoconstriction, reduces absorption of anesthetic drug into the system circulation. Currently, a comparative study on the effect of pain reduction of Adrenaline injection in the anesthetic cocktail is relatively low. There are different doses in each institution. In addition, the use of new anesthetic is Levobupivacaine that has more vasoconstrictive effect compare with traditional Bupivacaine. It also reduces the side effects of systemic and cardiotoxic effect. Therefore, the investigators think that It may not be necessary to mix Adrenaline in the multimodal anesthetic drug. Levobupivacaine already to avoid the potential side effects of Adrenaline.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: 0.6 mg 1:1000 epinephrine (0.6 ml) Phase 2

Detailed Description:

The patients will be divided into two groups. In group 1, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL) and 30 mg ketorolac (1 ml). In group 2, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL), 30 mg ketorolac (1 ml) and 0.6 mg 1:1000 epinephrine (0.6 ml). Both groups were mixed with a 0.9% normal saline solution to a total volume of 100 ml. The outcome research assistant who collects data was blinded to the treatment groups. Patients will be treated with the routine standard regimen for total knee arthroplasty. Surgeons will use same surgical techniques through a standard medial parapatellar approach. In addition, standardized posterior-stabilized TKA (Zimmer Nexgen LPS flex) was used in all patients. After bone cutting before inserting the actual implant, the assistant scrub nurse in the operating room will open the envelope that the patient was classified in group 1 or group 2 and perform mixing according to the prescribed medication. The doctor who undergoes surgery was blinded. The anesthetic cocktail was divided into 4 parts 25 ml each and it was injected into 4 areas. First 25 ml cocktail was injected into the posterior capsule (P), posteromedial (PM) and posterolateral capsule (PL). The second part was injected into the medial gutter (M). The third part was injected into the lateral gutter and the forth part was injected into quadriceps muscle, retinacula tissues, pes anserinus, suprapatellar and infrapatellar fat pads (A). During the first 48 hours, all patients received intravenous morphine prn for pain, as well as dynastat, Tylenol with codeine, as required, for control of pain. After 48 hours, the pain was controlled by oral intravenous morphine and medication as requires until the patient was discharged from the hospital.

The primary outcome measure was the severity of postoperative pain during the first 48 hours after surgery. The pain was assessed by a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain) every 6 hours postoperatively. Secondary outcome measures compared the consumption of intravenous morphine, which was measured every six hours in 48 hours after surgery. Additionally, blood loss in the drain at 24, 48 hours was recorded. Any complications following surgery were recorded.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Adrenaline in Periarticular Analgesic Injection on Postoperative Pain Control After Total Knee Arthroplasty: A Randomized Controlled Trial
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2018


Arm Intervention/treatment
Experimental: MAC with adrenaline
the multimodal anesthetic cocktail (MAC) consisted of 100 mg Levobupivacaine (0.5%, 20 mL) 30 mg ketorolac (1 ml) and 0.6 mg 1:1000 epinephrine (0.6 ml). They were mixed with a 0.9% normal saline solution to a total volume of 100 ml.
Drug: 0.6 mg 1:1000 epinephrine (0.6 ml)
In group 1, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL) 30 mg ketorolac (1 ml) and 0.6 mg 1:1000 epinephrine (0.6 ml). In group 2, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL) and 30 mg ketorolac (1 ml). Both groups were mixed with a 0.9% normal saline solution to a total volume of 100 ml.
Other Names:
  • 100 mg Levobupivacaine (0.5%, 20 mL)
  • 30 mg ketorolac (1 ml)

No Intervention: MAC without adrenaline
the multimodal anesthetic cocktail (MAC) consisted of 100 mg Levobupivacaine (0.5%, 20 mL) and 30 mg ketorolac (1 ml). They were mixed with a 0.9% normal saline solution to a total volume of 100 ml.



Primary Outcome Measures :
  1. the severity of postoperative pain [ Time Frame: The first 48 hours after surgery ]
    The pain was assessed by a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain) every 6 hours postoperatively.


Secondary Outcome Measures :
  1. the consumption of intravenous morphine [ Time Frame: The first 48 hours after surgery ]
    the consumption of intravenous morphine, which was measured every six hours

  2. blood loss in the drain [ Time Frame: at 24, 48 hours after surgery ]
    blood loss in the radivac drain



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with primary knee osteoarthritis
  • Aged between 40 and 80 years
  • Must be able to understand and willing to follow instructions

Exclusion Criteria:

  • Patients unable to undergo anesthesia during surgery by spinal block or adductor block
  • Patients with the history of levobupivacaine, etoricoxib drug allergy
  • Patients with the history of allergic or nausea vomiting severely when receiving morphine
  • Patients with kidney disease who have a creatinine clearance of less than 50 ml/min, cirrhosis, cardiovascular disease, stroke, poorly controlled hypertension
  • Patients with the history of venous thrombosis
  • Patients with complications during surgery such as torn ligaments
  • Patients who refuse to participate in the research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549221


Contacts
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Contact: Chaturong Pornrattanamaneewong, MD 6681-7553977 toonchaturong@gmail.com
Contact: Suphawat Tantithawornwat, MD 6686-9088084 dr.suphawat@gmail.com

Locations
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Thailand
Chaturong Pornrattanamaneewong Recruiting
Bangkok, Thailand, 10700
Contact: Rapeepat Narkbunnam, MD    6681-9351669    mai_parma@hotmail.com   
Contact: Keerati Chareancholvanivh, MD    6681-8188568    keesi93@gmail.com   
Sub-Investigator: Suphawat Tantithawornwat, MD         
Sub-Investigator: Chaturong Pornrattanamaneewong, MD         
Principal Investigator: Keerati Chareancholvanich, MD         
Sub-Investigator: Rapeepat Narkbunnam, MD         
Sponsors and Collaborators
Mahidol University
Investigators
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Study Chair: Keerati Chareancholvanich, MD Mahidol University

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Responsible Party: Chaturong Pornrattanamaneewong, Assistant Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT03549221     History of Changes
Other Study ID Numbers: 696/2560
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chaturong Pornrattanamaneewong, Mahidol University:
total knee arthroplasty
multimodal anesthetic cocktail
adrenaline
morphine consumption
blood loss
Levobupivacaine

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics
Levobupivacaine
Analgesics
Ketorolac
Ketorolac Tromethamine
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics