Total Knee ReplacementPhase 4NCT01312415
The Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement
A Phase 4 study testing Levobupivacaine and Intrathecal morphine in people with Total Knee Replacement, run by Cork University Hospital at 1 site in Ireland.
Trial summary
Total knee replacement (TKR) is associated postoperatively with considerable pain and analgesic requirement. Total knee replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine plus preservative free morphine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Levobupivacaine and Intrathecal morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIreland
- Study dates
- Aug 2010to Jun 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for unilateral total knee replacement
- Consent to spinal anaesthesia
- ASA Grade I to III
Who cannot join
- Patient refusal
- Mini-Mental Score < 25 (see appendix 3)
- Allergy to bupivacaine, morphine, paracetamol, diclofenac
- Skin lesions/infection at site of injection
- Uncorrected renal dysfunction
- Coagulation disorders
- chronic pain condition other than knee pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement
Total knee replacement (TKR) is associated postoperatively with considerable pain and analgesic requirement. Total knee replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine plus preservative free morphine. We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management.
We further hypothesize that the use of this surgical site infiltration technique would decrease post-operative systemic opioid requirements as well as the side effects associated with intrathecal and systemic opioids.
- Conditions
- Total Knee Replacement
- Being tested
- Levobupivacaine, Intrathecal morphine
- Keywords
- total knee arthroplasty, total knee replacement, local infiltration analgesia, intra-articular local anaesthesia, patients undergoing total knee arthroplasty (total knee replacement)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Patients will receive peri- and intraarticular surgical site infiltration to the knee during surgery and before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight (maximum 200mg levobupivacaine will be used if the patient's weight exceeds 100kg) plus 0.5mg epinephrine made up to 100ml with saline. An intra-articular catheter will be placed by the surgeon before closure under the sterile surgical conditions and this will be left in situ in the wound. The patient will receive one further injection of 15ml of levobupivacaine 0.5% solution at 8am on the morning of the first postoperative day after which the catheter will be removed.
Intrathecal morphineDrug
Patients will receive spinal anaesthesia with intrathecal bupivacaine 0.5% (17.5 mg if greater than 70 kg and 15 mg if less than 70 kg) and preservative-free morphine (0.3 mg).
| Study group | Role | What they receive |
|---|---|---|
| levobupivacaine infiltration | Experimental | Patients will receive spinal anaesthesia with intrathecal bupivacaine (17.5 or 15 mg) without morphine, and will receive peri- and intraarticular surgical site infiltration before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight (maximum 200mg levobupivacaine) plus 0.5mg epinephrine made up to 100ml with saline. An intra-articular catheter will be placed by the surgeon before closure under the sterile surgical conditions and this will be left in situ in the wound. The patient will receive one further injection of 15ml of levobupivacaine 0.5% at 8am the following morning. Receives: Drug: Levobupivacaine |
| Control | Other | Patients will receive spinal anaesthesia with intrathecal bupivacaine 0.5% (17.5 mg if greater than 70 kg and 15 mg if less than 70 kg) and preservative-free morphine (0.3 mg). Receives: Drug: Intrathecal morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement
Measured: 24 hours postoperatively
Secondary outcomes (1)
Opioid consumption in total in the first 48 hours postoperatively
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startAug 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cork University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Denise M McCarthy, MB FCARSCI, Principal investigator, Cork University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312415
- Sponsor's protocol ID
- TKR-SMOH
- Status last verified
- Mar 2011
- First submitted
- 9 Mar 2011
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
McCarthy D, McNamara J, Galbraith J, Loughnane F, Shorten G, Iohom G. A comparison of the analgesic efficacy of local infiltration analgesia vs. intrathecal morphine after total knee replacement: A randomised controlled trial. Eur J Anaesthesiol. 2019 Apr;36(4):264-271. doi: 10.1097/EJA.0000000000000943.
PubMed 30640244
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01312415
- Acronym / sponsor ID
- TKR-SMOH
- Conditions
- Total Knee Replacement
- Keywords
- total knee arthroplasty, total knee replacement, local infiltration analgesia, intra-articular local anaesthesia, patients undergoing total knee arthroplasty (total knee replacement)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cork University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 10 Mar 2011 (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 replacement (TKR) is associated postoperatively with considerable pain and analgesic requirement. Total knee replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine plus preservative free morphine. We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management.
We further hypothesize that the use of this surgical site infiltration technique would decrease post-operative systemic opioid requirements as well as the side effects associated with intrathecal and systemic opioids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levobupivacaine infiltration | Experimental | Drug: LevobupivacainePatients will receive spinal anaesthesia with intrathecal bupivacaine (17.5 or 15 mg) without morphine, and will receive peri- and intraarticular surgical site infiltration before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight (maximum 200mg levobupivacaine) plus 0.5mg epinephrine made up to 100ml with saline. An intra-articular catheter will be placed by the surgeon before closure under the sterile surgical conditions and this will be left in situ in the wound. The patient will receive one further injection of 15ml of levobupivacaine 0.5% at 8am the following morning. |
| Control | Other | Drug: Intrathecal morphinePatients will receive spinal anaesthesia with intrathecal bupivacaine 0.5% (17.5 mg if greater than 70 kg and 15 mg if less than 70 kg) and preservative-free morphine (0.3 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for unilateral total knee replacement
- Consent to spinal anaesthesia
- ASA Grade I to III
Key exclusion criteria (7 listed)
- Patient refusal
- Mini-Mental Score < 25 (see appendix 3)
- Allergy to bupivacaine, morphine, paracetamol, diclofenac
- Skin lesions/infection at site of injection
- Uncorrected renal dysfunction
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 |
|---|---|---|
| LevobupivacainePatients will receive peri- and intraarticular surgical site infiltration to the knee during surgery and before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight (maximum 200mg levobupivacaine will be used if the patient's weight exceeds 100kg) plus 0.5mg epinephrine made up to 100ml with saline. An intra-articular catheter will be placed by the surgeon before closure under the sterile surgical conditions and this will be left in situ in the wound. The patient will receive one further injection of 15ml of levobupivacaine 0.5% solution at 8am on the morning of the first postoperative day after which the catheter will be removed. | Drug | levobupivacaine infiltration |
| Intrathecal morphinePatients will receive spinal anaesthesia with intrathecal bupivacaine 0.5% (17.5 mg if greater than 70 kg and 15 mg if less than 70 kg) and preservative-free morphine (0.3 mg). | Drug | Control |
Primary outcome
Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement
Time frame: 24 hours postoperatively
1 secondary outcome
Opioid consumption in total in the first 48 hours postoperatively
Time frame: 48 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2011.
- Derived from this study: PubMed 30640244McCarthy D, McNamara J, Galbraith J, Loughnane F, Shorten G, Iohom G. A comparison of the analgesic efficacy of local infiltration analgesia vs. intrathecal morphine after total knee replacement: A randomised controlled trial. Eur J Anaesthesiol. 2019 Apr;36(4):264-271. doi: 10.1097/EJA.0000000000000943.
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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.
Denise M McCarthy, MB FCARSCI principal investigator
Cork University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine and Intrathecal morphine in people with Total Knee Replacement, run by Cork University Hospital at 1 site in Ireland.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Mar 2011. 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 Ireland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denise M McCarthy, MB FCARCSI (353-87-2341254, dmc_btown@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01312415, which also lists 1 linked publication.
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 10 Mar 2011.