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Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk?

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mL
Drug injection at Anterior soft tissue (25 mL)+Medial gutter area (25 mL)+Lateral gutter area (25 mL)+Posterior capsular infiltration (25 mL)
Drug injection at Anterior soft tissue (34 mL)+Medial gutter area (33 mL)+Lateral gutter area (33 mL
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Local anesthetic infiltration, Posterior capsular infiltration, Multimodal anesthesia, Knee arthroplasty, Pain control, Osteoarthritis, Knee

Eligibility Criteria

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

Inclusion Criteria:

  • Primary OA of the knee, aged less than 80 years old, and able to understand and comply with the study procedures.

Exclusion Criteria:

  • Previous drug dependency
  • Inability to undergo a spinal block
  • Allergy to study drugs
  • Renal insufficiency
  • Abnormal liver function
  • History of stroke
  • History of coronary artery disease

Sites / Locations

  • Thammasat university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LAI with PCI

LAI without PCI

Arm Description

Local anesthetic infiltration with posterior capsular injection (Drug inject at Anterior soft tissue, Medial gutter area, Lateral gutter area and Posterior capsular area)

Local anesthetic infiltration without posterior capsular injection (Drug inject at Anterior soft tissue, Medial gutter area and Lateral gutter area)

Outcomes

Primary Outcome Measures

The visual analogue scale (VAS) for pain

Secondary Outcome Measures

Morphine consumption from patient controlled analgesia (PCA)
The visual analogue scale (VAS) for satisfaction

Full Information

First Posted
July 24, 2016
Last Updated
October 22, 2016
Sponsor
Thammasat University
Collaborators
Boontanapibul, Krit, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT02860949
Brief Title
Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk?
Official Title
Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk? A Prospective, Double-Blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
Collaborators
Boontanapibul, Krit, M.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Multimodal local anesthetic infiltration (LAI) provides effective pain control in patients undergoing total knee arthroplasty (TKA). Some surgeons avoid posterior capsular infiltration (PCI) for fear of damaging posterior neurovascular structures. Data are limited on the added benefits of PCI using different combinations of local anesthetic agents. Therefore, the investigator wanted to know the effectiveness of pain control in LAI with and without PCI. Half of participants received LAI with PCI, while the other half received LAI without PCI during total knee arthroplasty.
Detailed Description
Analgesic agents were bupivacaine, morphine, ketorolac and epinephrine. All patients received spinal anesthesia and patient controlled analgesia (PCA) for 24 hours post surgery. The surgical technique and postoperative medication protocols were identical in both groups. The visual analogue scale (VAS) for pain during activity and at rest, and morphine consumption were recorded at 6, 12, 18 and 24 hours postoperatively. LAI-related side effects, blood loss, length of hospital stay, and VAS for satisfaction were monitored. The reviewer was blinded to treatment groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Local anesthetic infiltration, Posterior capsular infiltration, Multimodal anesthesia, Knee arthroplasty, Pain control, Osteoarthritis, Knee

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
LAI with PCI
Arm Type
Experimental
Arm Description
Local anesthetic infiltration with posterior capsular injection (Drug inject at Anterior soft tissue, Medial gutter area, Lateral gutter area and Posterior capsular area)
Arm Title
LAI without PCI
Arm Type
Active Comparator
Arm Description
Local anesthetic infiltration without posterior capsular injection (Drug inject at Anterior soft tissue, Medial gutter area and Lateral gutter area)
Intervention Type
Drug
Intervention Name(s)
0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mL
Intervention Type
Procedure
Intervention Name(s)
Drug injection at Anterior soft tissue (25 mL)+Medial gutter area (25 mL)+Lateral gutter area (25 mL)+Posterior capsular infiltration (25 mL)
Intervention Type
Procedure
Intervention Name(s)
Drug injection at Anterior soft tissue (34 mL)+Medial gutter area (33 mL)+Lateral gutter area (33 mL
Primary Outcome Measure Information:
Title
The visual analogue scale (VAS) for pain
Time Frame
24 hours after the operation
Secondary Outcome Measure Information:
Title
Morphine consumption from patient controlled analgesia (PCA)
Time Frame
24 hours after the operation
Title
The visual analogue scale (VAS) for satisfaction
Time Frame
24 hours after the operation

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: Primary OA of the knee, aged less than 80 years old, and able to understand and comply with the study procedures. Exclusion Criteria: Previous drug dependency Inability to undergo a spinal block Allergy to study drugs Renal insufficiency Abnormal liver function History of stroke History of coronary artery disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piya Pinsornsak, MD
Organizational Affiliation
Faculty of Medicine, Thammasat university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thammasat university hospital
City
Pathumthani
State/Province
Klongluang
ZIP/Postal Code
12120
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk?

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