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Adductor Canal Versus Femoral Nerve Block for Analgesia Post Total Knee Arthroscopy

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Changi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total knee arthroplasty, Total knee replacement, Femoral Nerve Block, Adductor Canal Block

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ages 45-85
  • American Society of Anaesthesiologists physical status 1-3
  • BMI 18-35 kg/m2

Exclusion Criteria:

  • inability to give consent, communicate, cooperate
  • Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids
  • Patients with allergy to local anaesthetics or any drugs included in the study
  • Patients with lower limb surgery in the preceding year
  • Patients with pre-existing neurological deficits
  • Patients who are unsuitable for general anaesthetics (eg difficult airway)

Sites / Locations

  • Changi General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Femoral Nerve Block

Adductor Canal block

Arm Description

Femoral Nerve block performed with 0.5% Ropivacaine 30mls (150mg)

Adductor Canal block performed with 0.5% Ropivacaine 30mls (150mg)

Outcomes

Primary Outcome Measures

Morphine consumption

Secondary Outcome Measures

Pain scores
Morphine consumption
Side effects of opioids- sedation, nausea and vomiting
Quadriceps strength, ability to mobilise

Full Information

First Posted
January 9, 2014
Last Updated
December 31, 2014
Sponsor
Changi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02033603
Brief Title
Adductor Canal Versus Femoral Nerve Block for Analgesia Post Total Knee Arthroscopy
Official Title
A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Femoral Nerve Block for Analgesia Post Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changi General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Total knee arthroplasty or replacement (TKA) is a surgery performed for osteoarthritis of the knee which is increasingly performed as the population ages. It is a painful surgery and one of the methods to reduce post-operative pain is performing a regional anaesthesia technique. The current practice is to perform a femoral nerve block (FNB) which blocks the nerves supplying the knee joint and the thigh muscles (quadriceps). This provides effective analgesia. However, it also results in weakness of the quadriceps and may result in falls post-operatively. Adductor canal block (ACB) is a new, alternative regional anaesthesia technique which is hypothesised to provide as effective analgesia, with less quadriceps weakness compared to FNB, hence potentially reducing the risk of falls post-operatively. Investigators aim to study if the analgesia provided by ACB is as good as FNB while preserving quadriceps strength.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Total knee arthroplasty, Total knee replacement, Femoral Nerve Block, Adductor Canal Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Femoral Nerve Block
Arm Type
Active Comparator
Arm Description
Femoral Nerve block performed with 0.5% Ropivacaine 30mls (150mg)
Arm Title
Adductor Canal block
Arm Type
Active Comparator
Arm Description
Adductor Canal block performed with 0.5% Ropivacaine 30mls (150mg)
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
naropin
Intervention Description
30mls of 0.5% ropivacaine
Primary Outcome Measure Information:
Title
Morphine consumption
Time Frame
first 24 hours
Secondary Outcome Measure Information:
Title
Pain scores
Time Frame
1, 6, 12, 24, 48
Title
Morphine consumption
Time Frame
48 hours
Title
Side effects of opioids- sedation, nausea and vomiting
Time Frame
48 hours
Title
Quadriceps strength, ability to mobilise
Time Frame
24, 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ages 45-85 American Society of Anaesthesiologists physical status 1-3 BMI 18-35 kg/m2 Exclusion Criteria: inability to give consent, communicate, cooperate Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids Patients with allergy to local anaesthetics or any drugs included in the study Patients with lower limb surgery in the preceding year Patients with pre-existing neurological deficits Patients who are unsuitable for general anaesthetics (eg difficult airway)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CTRU CGH
Phone
67888833
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yean Chin Lim, MBBS, MMed
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CTRU
Phone
67888833

12. IPD Sharing Statement

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Adductor Canal Versus Femoral Nerve Block for Analgesia Post Total Knee Arthroscopy

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