AnalgesiaPhase 4NCT00869037
Analgesia After Total Knee Arthroplasty
A Phase 4 study testing Periarticular Injection and CFNB + Posterior Capsular Injection in people with Analgesia, run by University of Manitoba at 1 site in Canada.
Trial summary
The recovery from knee replacement surgery often involves a significant amount of pain. The best way to prevent/treat this pain is unknown. This study will compare two accepted methods of pain control in order to determine which is superior. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Periarticular Injection and CFNB + Posterior Capsular Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Feb 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I, II, \& III patients
- Elective primary total knee arthroplasty
- Spinal Anesthesia
Who cannot join
- Patients refusing consent
- Contraindications to regional anesthesia
- Pre-existing neurological disease
- Allergy/contraindication to drugs used in the study
- Revision knee arthroplasty
- Patients with chronic pain/on narcotics preoperatively
Show all 11Show fewer
- Pre-existing Rheumatoid Arthritis/Ankylosing Spondylitis
- Alcohol or drug abuse
- Psychiatric disorders
- Inability to use the outcome assessment tools
- Wheel chair or walker dependent for mobilization
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Concordia Hospital
Winnipeg, Manitoba, R2K 3S8
About this study
Official title: Analgesia After Total Knee Arthroplasty: Randomized Controlled Trial Comparing (a) Periarticular Multimodal Technique With (B) Continuous Femoral Nerve Block + Posterior Capsular Injection
The recovery from knee replacement surgery often involves a significant amount of pain. The best way to prevent/treat this pain is unknown. This study will compare two accepted methods of pain control in order to determine which is superior. The first method involves the injection of a solution containing multiple medications into the knee joint at the time of surgery. The second method involves the placement of a catheter adjacent to the femoral nerve which senses pain from the knee. This catheter is used to deliver local anesthetic which serves to block the transmission of pain signals from the nerve. The catheter will be left in place until 2 days after surgery. This method is combined with injection of local anesthetic in a particular area of the knee joint at the time of surgery. Patients will be followed until 2 days after surgery in order to determine which method is superior. We believe the second method will be deemed superior.
- Conditions
- Analgesia
- Being tested
- Periarticular Injection, CFNB + Posterior Capsular Injection
- Keywords
- Randomized controlled study, Total knee arthroplasty, Post operative pain, Continuous Femoral Nerve Block, Posterior Capsular injection, Periarticular injection
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periarticular InjectionDrug
A 20 ml bolus of saline will be given through the sham femoral nerve block catheter. Periarticular infiltration solution containing 400 mg Ropivicaine, 30 mg Ketorolac, 5 mg Epidural Grade Morphine, and 0.6 ml of 1:1000 Epinephrine will be made up to a volume of 100 ml with saline. Intra-op, 20 ml will be injected into the posterior capsule; 40 ml in the quadriceps mechanism, retinacular tissues, medial and lateral collateral ligaments; 40 ml in the skin and subcutaneous tissues. The sham catheter will be connected to a saline infusion running at 15 ml/hr until the morning of post-operative day 2.
CFNB + Posterior Capsular InjectionDrug
A 20 ml bolus of 0.2% Ropivacaine will be given via a femoral nerve catheter. Periarticular infiltration will be performed intra-op. 20 ml of 1% Ropivacaine in the posterior capsule; 20 ml of normal saline in the quadriceps mechanism, retinacular tissues, medial and lateral collateral ligaments; 20 ml of normal saline for the skin and subcutaneous tissues. Postoperatively, the femoral catheter will be infused with 0.15% Ropivacaine running at 15 ml/hour until the morning of post-operative day 2
| Study group | Role | What they receive |
|---|---|---|
| Periarticluar Multimodal Technique | Active comparator | Not described Receives: Drug: Periarticular Injection |
| CFNB plus Posterior Capsular Injection | Active comparator | Not described Receives: Drug: CFNB + Posterior Capsular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static and dynamic pain scores until post-operative day 2 (POD 2)
Measured: 9:00 and 15:30 daily for the first 2 postoperative days
Secondary outcomes (9)
Equivalent narcotic consumption until POD 2
Measured: 9:00 and 15:30 daily until POD 2
Number of patients requiring Ketamine and ketamine dosage for intractable pain
Measured: 9:00 and 15:30 daily until POD 2
Number of patients requiring Cryo-Cuff for intractable pain
Measured: 9:00 and 15:30 daily until POD 2
Number of patients with pain scores in the mild (numerical rating scale 0-3), moderate (NRS 3-7) and severe (NRS 7-10) range
Measured: 9:00 and 15:30 daily until POD 2
Incidence of narcotic related side effects (nausea, vomiting, pruritis, euphoria, dysphoria, hallucination, respiratory depression)
Measured: 9:00 and 15:30 daily until POD 2
Number of patients able to mobilize with or without a frame
Measured: POD 1-2
Maximum knee flexion (active/passive)
Measured: POD 1-2, at discharge, and at first follow-up visit
Hospital length of stay
Measured: Until Hospital discharge
Patient satisfaction scores
Measured: POD 0-2, at hospital discharge, and at first postoperative follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2011 (estimated)
- Study completionFeb 2012 (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 AnalgesiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Sanjay Aragola, MD, FRCA, Principal investigator, University of ManitobaMarshall S Tenenbein, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869037
- Sponsor's protocol ID
- B2008:123
- Status last verified
- Jan 2010
- First submitted
- 24 Mar 2009
- Last updated
- 24 Mar 2011
- Results posted
- No
Publications
Aragola S, Arenson B, Tenenbein M, Bohm E, Jacobsohn E, Turgeon T. Prospective randomized trial of continuous femoral nerve block with posterior capsular injection versus periarticular injection for analgesia in primary total knee arthroplasty. Can J Surg. 2021 Apr 28;64(3):E265-E272. doi: 10.1503/cjs.020519.
PubMed 33908425
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia After Total Knee Arthroplasty: Randomized Controlled Trial Comparing (a) Periarticular Multimodal Technique With (B) Continuous Femoral Nerve Block + Posterior Capsular Injection
- ClinicalTrials.gov ID
- NCT00869037
- Acronym / sponsor ID
- B2008:123
- Conditions
- Analgesia
- Keywords
- Randomized controlled study, Total knee arthroplasty, Post operative pain, Continuous Femoral Nerve Block, Posterior Capsular injection, Periarticular injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 25 Mar 2009 (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.
The recovery from knee replacement surgery often involves a significant amount of pain. The best way to prevent/treat this pain is unknown. This study will compare two accepted methods of pain control in order to determine which is superior. The first method involves the injection of a solution containing multiple medications into the knee joint at the time of surgery. The second method involves the placement of a catheter adjacent to the femoral nerve which senses pain from the knee. This catheter is used to deliver local anesthetic which serves to block the transmission of pain signals from the nerve. The catheter will be left in place until 2 days after surgery. This method is combined with injection of local anesthetic in a particular area of the knee joint at the time of surgery. Patients will be followed until 2 days after surgery in order to determine which method is superior. We believe the second method will be deemed superior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periarticluar Multimodal Technique | Active comparator | Drug: Periarticular Injection |
| CFNB plus Posterior Capsular Injection | Active comparator | Drug: CFNB + Posterior Capsular Injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I, II, \& III patients
- Elective primary total knee arthroplasty
- Spinal Anesthesia
Key exclusion criteria (11 listed)
- Patients refusing consent
- Contraindications to regional anesthesia
- Pre-existing neurological disease
- Allergy/contraindication to drugs used in the study
- Revision knee arthroplasty
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 |
|---|---|---|
| Periarticular InjectionA 20 ml bolus of saline will be given through the sham femoral nerve block catheter. Periarticular infiltration solution containing 400 mg Ropivicaine, 30 mg Ketorolac, 5 mg Epidural Grade Morphine, and 0.6 ml of 1:1000 Epinephrine will be made up to a volume of 100 ml with saline. Intra-op, 20 ml will be injected into the posterior capsule; 40 ml in the quadriceps mechanism, retinacular tissues, medial and lateral collateral ligaments; 40 ml in the skin and subcutaneous tissues. The sham catheter will be connected to a saline infusion running at 15 ml/hr until the morning of post-operative day 2. | Drug | Periarticluar Multimodal Technique |
| CFNB + Posterior Capsular InjectionA 20 ml bolus of 0.2% Ropivacaine will be given via a femoral nerve catheter. Periarticular infiltration will be performed intra-op. 20 ml of 1% Ropivacaine in the posterior capsule; 20 ml of normal saline in the quadriceps mechanism, retinacular tissues, medial and lateral collateral ligaments; 20 ml of normal saline for the skin and subcutaneous tissues. Postoperatively, the femoral catheter will be infused with 0.15% Ropivacaine running at 15 ml/hour until the morning of post-operative day 2 | Drug | CFNB plus Posterior Capsular Injection |
Primary outcome
Static and dynamic pain scores until post-operative day 2 (POD 2)
Time frame: 9:00 and 15:30 daily for the first 2 postoperative days
9 secondary outcomes
Equivalent narcotic consumption until POD 2
Time frame: 9:00 and 15:30 daily until POD 2
Number of patients requiring Ketamine and ketamine dosage for intractable pain
Time frame: 9:00 and 15:30 daily until POD 2
Number of patients requiring Cryo-Cuff for intractable pain
Time frame: 9:00 and 15:30 daily until POD 2
Number of patients with pain scores in the mild (numerical rating scale 0-3), moderate (NRS 3-7) and severe (NRS 7-10) range
Time frame: 9:00 and 15:30 daily until POD 2
Incidence of narcotic related side effects (nausea, vomiting, pruritis, euphoria, dysphoria, hallucination, respiratory depression)
Time frame: 9:00 and 15:30 daily until POD 2
Number of patients able to mobilize with or without a frame
Time frame: POD 1-2
Maximum knee flexion (active/passive)
Time frame: POD 1-2, at discharge, and at first follow-up visit
Hospital length of stay
Time frame: Until Hospital discharge
Patient satisfaction scores
Time frame: POD 0-2, at hospital discharge, and at first postoperative follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2011.
- Derived from this study: PubMed 33908425Aragola S, Arenson B, Tenenbein M, Bohm E, Jacobsohn E, Turgeon T. Prospective randomized trial of continuous femoral nerve block with posterior capsular injection versus periarticular injection for analgesia in primary total knee arthroplasty. Can J Surg. 2021 Apr 28;64(3):E265-E272. doi: 10.1503/cjs.020519.
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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.
Sanjay Aragola, MD, FRCA principal investigator
University of Manitoba
Marshall S Tenenbein, MD principal investigator
University of Manitoba
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 Periarticular Injection and CFNB + Posterior Capsular Injection in people with Analgesia, run by University of Manitoba at 1 site in Canada.
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 11 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 24 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 Canada. 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 Sanjay Aragola, MD FRCA (1-204-6617198, saragola@sbgh.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static and dynamic pain scores until post-operative day 2 (POD 2) (time frame: 9:00 and 15:30 daily for the first 2 postoperative days). 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 NCT00869037, 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 24 Mar 2011; AzTrials last refreshed its copy on 1 Nov 2026.