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 : Unknown

Verified June 2018 by Chaturong Pornrattanamaneewong, Mahidol University.
Recruitment status was: Recruiting

First Posted : June 7, 2018

Last Update Posted : June 12, 2018

Sponsor:

Information provided by (Responsible Party):

Chaturong Pornrattanamaneewong, Mahidol University

Study Description

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.

Study Design

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine Ketorolac

U.S. FDA Resources

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures :

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 :

the consumption of intravenous morphine [ Time Frame: The first 48 hours after surgery ]
the consumption of intravenous morphine, which was measured every six hours
blood loss in the drain [ Time Frame: at 24, 48 hours after surgery ]
blood loss in the radivac drain

Eligibility Criteria

Information from the National Library of Medicine

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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.

Contacts and Locations

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

More Information

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Responsible Party:	Chaturong Pornrattanamaneewong, Assistant Professor, Mahidol University
ClinicalTrials.gov Identifier:	NCT03549221
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 Ketorolac Epinephrine Levobupivacaine Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-Agonists	Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors

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