Analgesia in Total Knee ArthroplastyNCT02104934
A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
A study testing Adductor Canal Block in people with Analgesia in Total Knee Arthroplasty, run by Changi General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Analgesia in Total Knee Arthroplasty
- What is being tested?
- Adductor Canal Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Analgesia in Total Knee Arthroplasty
- Being tested
- Adductor Canal Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal BlockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Local Infiltration Analgesia | No intervention | 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. |
| Adductor Canal Block | Active comparator | 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. Receives: Procedure: Adductor Canal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption in the first 24 hours
morphine consumption in the first 24 hours (including morphine administered in recovery and via PCA).
Measured: 24 hours
Secondary outcomes (5)
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.
Measured: 1, 6, 12, 24 hours; up to 48 hours postoperative
Morphine Consumption
The balance usage after primary outcome
Measured: At 48 hours
Postoperative Nausea and Vomiting
Presence/absence of nausea and vomiting, and total number of episodes of vomiting
Measured: Up to 48 hours
Sedation Scores
Measured: Up to 48 hours
Quadriceps Strength
Measured: at 24 and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia in Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yean Chin Lim, MBBS, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104934
- Sponsor's protocol ID
- CGHLIAACB2013
- Status last verified
- Jul 2015
- First submitted
- 18 Mar 2014
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02104934
- Acronym / sponsor ID
- CGHLIAACB2013
- Conditions
- Analgesia in Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Infiltration Analgesia | No intervention | –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. |
| Adductor Canal Block | Active comparator | Procedure: Adductor Canal BlockThe 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adductor Canal Block | Procedure or surgery | Adductor Canal Block |
Primary outcome
Morphine consumption in the first 24 hours
Time frame: 24 hours
morphine consumption in the first 24 hours (including morphine administered in recovery and via PCA).
5 secondary outcomes
Pain Scores
Time frame: 1, 6, 12, 24 hours; up to 48 hours postoperative
Morphine Consumption
Time frame: At 48 hours
Postoperative Nausea and Vomiting
Time frame: Up to 48 hours
Sedation Scores
Time frame: Up to 48 hours
Quadriceps Strength
Time frame: at 24 and 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Analgesia in Total Knee Arthroplasty
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Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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A Randomized Comparison of the Efficacy of the IPACK Block Versus the Popliteal Plexus Block for Posterior Knee Analgesia, in Patients Undergoing a Total Knee Arthroplasty and Receiving a Continuous Distal Femoral Triangle Block
Osteoarthritis, Knee, Postoperative Pain
RecruitingPhase 3
Suzetrigine in TKA
Total Knee Arthroplasty (TKA), Total Knee Arthroplasty \(TKA\)
Not yet recruiting
Continuous Adductor Canal Block (CACB) Combined With İnfiltration Between the Popliteal Artery and Capsule of the Knee (iPACK) Block vs Continuous Adductor Canal Block Alone After Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Pain
Not yet recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yean Chin Lim, MBBS principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adductor Canal Block in people with Analgesia in Total Knee Arthroplasty, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption in the first 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.