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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
0.6 mg 1:1000 epinephrine (0.6 ml)
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring total knee arthroplasty, multimodal anesthetic cocktail, adrenaline, morphine consumption, blood loss, Levobupivacaine

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chaturong PornrattanamaneewongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MAC with adrenaline

MAC without adrenaline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

the consumption of intravenous morphine
the consumption of intravenous morphine, which was measured every six hours
blood loss in the drain
blood loss in the radivac drain

Full Information

First Posted
May 25, 2018
Last Updated
June 8, 2018
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT03549221
Brief Title
Efficacy of Adrenaline in Periarticular Analgesic Injection on Postoperative Pain Control After Total Knee Arthroplasty
Official Title
Efficacy of Adrenaline in Periarticular Analgesic Injection on Postoperative Pain Control After Total Knee Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
October 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
total knee arthroplasty, multimodal anesthetic cocktail, adrenaline, morphine consumption, blood loss, Levobupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MAC with adrenaline
Arm Type
Experimental
Arm Description
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.
Arm Title
MAC without adrenaline
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
0.6 mg 1:1000 epinephrine (0.6 ml)
Other Intervention Name(s)
100 mg Levobupivacaine (0.5%, 20 mL), 30 mg ketorolac (1 ml)
Intervention Description
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.
Primary Outcome Measure Information:
Title
the severity of postoperative pain
Description
The pain was assessed by a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain) every 6 hours postoperatively.
Time Frame
The first 48 hours after surgery
Secondary Outcome Measure Information:
Title
the consumption of intravenous morphine
Description
the consumption of intravenous morphine, which was measured every six hours
Time Frame
The first 48 hours after surgery
Title
blood loss in the drain
Description
blood loss in the radivac drain
Time Frame
at 24, 48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chaturong Pornrattanamaneewong, MD
Phone
6681-7553977
Email
toonchaturong@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suphawat Tantithawornwat, MD
Phone
6686-9088084
Email
dr.suphawat@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keerati Chareancholvanich, MD
Organizational Affiliation
Mahidol University
Official's Role
Study Chair
Facility Information:
Facility Name
Chaturong Pornrattanamaneewong
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rapeepat Narkbunnam, MD
Phone
6681-9351669
Email
mai_parma@hotmail.com
First Name & Middle Initial & Last Name & Degree
Keerati Chareancholvanivh, MD
Phone
6681-8188568
Email
keesi93@gmail.com
First Name & Middle Initial & Last Name & Degree
Suphawat Tantithawornwat, MD
First Name & Middle Initial & Last Name & Degree
Chaturong Pornrattanamaneewong, MD
First Name & Middle Initial & Last Name & Degree
Keerati Chareancholvanich, MD
First Name & Middle Initial & Last Name & Degree
Rapeepat Narkbunnam, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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