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

NCT03549221 | Unknown Phase 2

• 1 other identifier: 696/2560
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

total knee arthroplasty; multimodal anesthetic cocktail; adrenaline; morphine consumption; blood loss; Levobupivacaine

Outcome Measures

Primary Outcomes (1)

• the severity of postoperative pain

  The pain was assessed by a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain) every 6 hours postoperatively.

  The first 48 hours after surgery

Secondary Outcomes (2)

• the consumption of intravenous morphine

  The first 48 hours after surgery

• blood loss in the drain

  at 24, 48 hours after surgery

Study Arms (2)

MAC with adrenaline

EXPERIMENTAL

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)

MAC without adrenaline

NO INTERVENTION

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.

Interventions

0.6 mg 1:1000 epinephrine (0.6 ml) DRUG

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.

Also known as: 100 mg Levobupivacaine (0.5%, 20 mL), 30 mg ketorolac (1 ml)

MAC with adrenaline

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Chaturong Pornrattanamaneewong

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Hemorrhage

Interventions

Epinephrine; Levobupivacaine; Ketorolac

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Bupivacaine; Anilides; Amides; Aniline Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Keerati Chareancholvanich, MD

  Mahidol University

  STUDY CHAIR

Central Study Contacts

Chaturong Pornrattanamaneewong, MD

CONTACT

6681-7553977; toonchaturong@gmail.com

Suphawat Tantithawornwat, MD

CONTACT

6686-9088084; dr.suphawat@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 7, 2018
• Study Start: January 26, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: June 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)