A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 18, 2014
CompletedFirst Posted
Study publicly available on registry
April 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 25, 2017
July 1, 2015
1.8 years
March 18, 2014
April 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Morphine consumption in the first 24 hours
morphine consumption in the first 24 hours (including morphine administered in recovery and via PCA).
24 hours
Secondary Outcomes (5)
Pain Scores
1, 6, 12, 24 hours; up to 48 hours postoperative
Morphine Consumption
At 48 hours
Postoperative Nausea and Vomiting
Up to 48 hours
Sedation Scores
Up to 48 hours
Quadriceps Strength
at 24 and 48 hours
Other Outcomes (2)
Presence of Complications
up to 48 hours
Length of Hospital Stay
Up to 30 days
Study Arms (2)
Local Infiltration Analgesia
NO INTERVENTIONThe 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.
Adductor Canal Block
ACTIVE COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changi General Hospital
Singapore, Singapore
Study Officials
- PRINCIPAL INVESTIGATOR
Yean Chin Lim, MBBS
Changi General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2014
First Posted
April 7, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2015
Study Completion
March 1, 2016
Last Updated
April 25, 2017
Record last verified: 2015-07