Back to resultsA Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
Primary Purpose
Analgesia in Total Knee Arthroplasty
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Adductor Canal Block
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia in Total Knee Arthroplasty
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for primary TKA under single shot spinal anaesthesia, between ages 45-85 years old, American Society of Anesthesiologists (ASA) physical status 1 to 3 and BMI 18-35 kg/m2
Exclusion Criteria:
- Patients unable to give consent, inability to communicate/ cooperate, patients with regular consumption of strong opioids (morphine, oxycodone) or steroids, 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 and patients who have contraindications for spinal anaesthesia.
Sites / Locations
- Changi General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Local Infiltration Analgesia
Adductor Canal Block
Arm Description
The Local Infiltration Analgesia group will receive local infiltration of ropivacaine 150mg, ketorolac 30mg, morphine 10mg, adrenaline 200mcg and vancomycin 500mg in a total volume of 75mls by the surgeon.
The Adductor Canal Block group of patients will receive intravenous ketorolac 30mg intra-operatively and an adductor canal block at the end of surgery. The block will be performed under real time ultrasound guidance and 30mls of 0.5% ropivacaine (150mg) is injected with a Stimuplex A100, 21G needle.
Outcomes
Primary Outcome Measures
Morphine consumption in the first 24 hours
morphine consumption in the first 24 hours (including morphine administered in recovery and via PCA).
Secondary Outcome Measures
Pain Scores
Pain scores are recorded at 1, 6, 12, 24 and 48 hours post-operatively, assessed using a visual analog scale (0-100mm) at rest and during 45 degree passive flexion of knee.
Morphine Consumption
The balance usage after primary outcome
Postoperative Nausea and Vomiting
Presence/absence of nausea and vomiting, and total number of episodes of vomiting
Sedation Scores
Quadriceps Strength
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02104934
Brief Title
A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
Official Title
A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)
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), a commonly performed surgery for osteoarthritis of the knee, is a painful procedure and requires a multimodal analgesic approach. A method for analgesia is local infiltration analgesia (LIA), where a mixture of drugs is injected around the knee joint.
Adductor canal block (ACB) is an alternative regional anaesthesia technique which has been shown to result in minimal thigh weakness.
The investigators aim to study if the analgesia provided by ACB is superior to LIA while preserving quadriceps strength.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia in Total Knee Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local Infiltration Analgesia
Arm Type
No Intervention
Arm Description
The Local Infiltration Analgesia group will receive local infiltration of ropivacaine 150mg, ketorolac 30mg, morphine 10mg, adrenaline 200mcg and vancomycin 500mg in a total volume of 75mls by the surgeon.
Arm Title
Adductor Canal Block
Arm Type
Active Comparator
Arm Description
The Adductor Canal Block group of patients will receive intravenous ketorolac 30mg intra-operatively and an adductor canal block at the end of surgery. The block will be performed under real time ultrasound guidance and 30mls of 0.5% ropivacaine (150mg) is injected with a Stimuplex A100, 21G needle.
Intervention Type
Procedure
Intervention Name(s)
Adductor Canal Block
Primary Outcome Measure Information:
Title
Morphine consumption in the first 24 hours
Description
morphine consumption in the first 24 hours (including morphine administered in recovery and via PCA).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain Scores
Description
Pain scores are recorded at 1, 6, 12, 24 and 48 hours post-operatively, assessed using a visual analog scale (0-100mm) at rest and during 45 degree passive flexion of knee.
Time Frame
1, 6, 12, 24 hours; up to 48 hours postoperative
Title
Morphine Consumption
Description
The balance usage after primary outcome
Time Frame
At 48 hours
Title
Postoperative Nausea and Vomiting
Description
Presence/absence of nausea and vomiting, and total number of episodes of vomiting
Time Frame
Up to 48 hours
Title
Sedation Scores
Time Frame
Up to 48 hours
Title
Quadriceps Strength
Time Frame
at 24 and 48 hours
Other Pre-specified Outcome Measures:
Title
Presence of Complications
Description
Hematoma, wound infection, neurological deficits, any incidence of fall
Time Frame
up to 48 hours
Title
Length of Hospital Stay
Description
Number of days till discharge
Time Frame
Up to 30 days
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:
Patients scheduled for primary TKA under single shot spinal anaesthesia, between ages 45-85 years old, American Society of Anesthesiologists (ASA) physical status 1 to 3 and BMI 18-35 kg/m2
Exclusion Criteria:
Patients unable to give consent, inability to communicate/ cooperate, patients with regular consumption of strong opioids (morphine, oxycodone) or steroids, 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 and patients who have contraindications for spinal anaesthesia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yean Chin Lim, MBBS
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changi General Hospital
City
Singapore
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
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