PainNCT01805661
Adductor Canal Block With Posterior Capsular Injection for Total Knee Replacement
A study testing Canal Block and Capsular Injection and Femoral with Tibial Nerve Block in people with Pain and Osteoarthritis, run by Trinity Health Of New England at 1 site in United States.
Trial summary
To compare early ambulation and ability to participate in rehabilitation in patients undergoing total knee replacement using two different nerve block techniques for pain control. The 2 methods are 1) Adductor canal block with posterior capsular injection 2) femoral nerve block with tibial nerve block Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Osteoarthritis
- What is being tested?
- Canal Block and Capsular Injection and Femoral with Tibial Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having primary, unilateral total knee arthroplasty
- ages 18 - 80
Who cannot join
- history of neurological disease
- neuropathy
- diabetes
- major systemic illness
- pregnancy
- chronic narcotic use
Show all 9Show fewer
- allergy to local anesthetic solution or NSAIDS
- inability to give consent or cooperate with the study protocol
- BMI> 40
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105
About this study
Official title: Assessment of Early Ambulation and Participation in Rehabilitation Program in Patients Receiving Continuous Adductor Canal Block With Ultrasound Guided Posterior Capsular Knee Injection vs Continuous Femoral Nerve Block With Tibial Nerve Block Following Total Knee Replacement.
To compare early ambulation and ability to participate in rehabilitation in patients undergoing total knee replacement using two different nerve block techniques for pain control. The 2 methods are 1) Adductor canal block with posterior capsular injection 2) femoral nerve block with tibial nerve block
Read the detailed description
Early mobilization in the postoperative period is important to the success of surgery following total knee replacement. However, severe post-operative pain is an impediment to early implementation of rehabilitaion program. The use of femoral nerve block combined with tibial nerve block as part of a multimodal analgesic program provides effective pain control but causes weakness of the operative extremity preventing patients from bearing weight, exercising the leg and increasing the risk of falls thereby delaying early participation in rehabilitation. Adductor canal block is a new technique that has been described to provide pain control after total knee arthroplasty (1). The advantages of this block is that it could potentially minimize lower extremity weakness because the target nerve (saphenous nerve) blocked in this technique is a purely sensory nerve and does not provide any motor innervation to any muscle groups. Adductor canal block lends itself easily to providing prolonged analgesia because a perineural catheter can be inserted and the block maintained by a continuous infusion of dilute local anesthetic solution for days. A disadvantage of this method is that it may not provide adequate analgesia for posterior knee pain in the early postoperative period. By combining adductor canal block with ultrasound guided posterior and antero-medial knee injection, the posterior knee pain can be controlled effectively. Posterior and antero-medial knee injection of local anesthetic solution has been used as a method of controlling posterior knee pain after total knee arthroplasty (2).
- Conditions
- Pain, Osteoarthritis
- Being tested
- Canal Block and Capsular Injection, Femoral with Tibial Nerve Block
- Keywords
- early ambulation, knee arthroplasty
- Medical subject headings
- Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canal Block and Capsular InjectionProcedure or surgery
Continuous Adductor canal block with 15-30ml of ropivacaine 0.1% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30 ml ropivacaine 0.1% with epinephrine 1:400,000.
Femoral with Tibial Nerve BlockProcedure or surgery
Continuous femoral nerve block with 15 ml of ropivacaine 0.1% followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.1% up to 15 ml.
| Study group | Role | What they receive |
|---|---|---|
| Femoral With Tibial Nerve Block | Active comparator | Continuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa Receives: Procedure: Femoral with Tibial Nerve Block |
| Canal Block and Capsular Injection | Experimental | Adductor canal block with a continuous catheter and ultrasound guided posterior capsular injection with local anesthetic solution. Receives: Procedure: Canal Block and Capsular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to ambulate post operatively.
Ability to ambulate and perform tasks of the rehabilitation program and reach rehabilitation milestones after total knee arthroplasty.
Measured: Up to 3 days (72 hours) post surgery.
Secondary outcomes (2)
Pain scores at rest and with knee flexion.
Measures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 72 hour period after discharge from recovery room.
Measured: Up to 3 days ( 72 hours) after surgery
Pain Medication Consumption
Amount of opioid consumption post surgery for 72 hours.
Measured: Up to 3 days (72 hours) post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Sinha, M.D., Principal investigator, Saint Francis Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805661
- Sponsor's protocol ID
- 12-10-002
- Status last verified
- Jan 2015
- First submitted
- 4 Mar 2013
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Early Ambulation and Participation in Rehabilitation Program in Patients Receiving Continuous Adductor Canal Block With Ultrasound Guided Posterior Capsular Knee Injection vs Continuous Femoral Nerve Block With Tibial Nerve Block Following Total Knee Replacement.
- ClinicalTrials.gov ID
- NCT01805661
- Acronym / sponsor ID
- 12-10-002
- Conditions
- Pain, Osteoarthritis
- Keywords
- early ambulation, knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Mar 2013 (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.
To compare early ambulation and ability to participate in rehabilitation in patients undergoing total knee replacement using two different nerve block techniques for pain control. The 2 methods are 1) Adductor canal block with posterior capsular injection 2) femoral nerve block with tibial nerve block
Detailed description
Early mobilization in the postoperative period is important to the success of surgery following total knee replacement. However, severe post-operative pain is an impediment to early implementation of rehabilitaion program. The use of femoral nerve block combined with tibial nerve block as part of a multimodal analgesic program provides effective pain control but causes weakness of the operative extremity preventing patients from bearing weight, exercising the leg and increasing the risk of falls thereby delaying early participation in rehabilitation. Adductor canal block is a new technique that has been described to provide pain control after total knee arthroplasty (1). The advantages of this block is that it could potentially minimize lower extremity weakness because the target nerve (saphenous nerve) blocked in this technique is a purely sensory nerve and does not provide any motor innervation to any muscle groups. Adductor canal block lends itself easily to providing prolonged analgesia because a perineural catheter can be inserted and the block maintained by a continuous infusion of dilute local anesthetic solution for days. A disadvantage of this method is that it may not provide adequate analgesia for posterior knee pain in the early postoperative period. By combining adductor canal block with ultrasound guided posterior and antero-medial knee injection, the posterior knee pain can be controlled effectively. Posterior and antero-medial knee injection of local anesthetic solution has been used as a method of controlling posterior knee pain after total knee arthroplasty (2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral With Tibial Nerve Block | Active comparator | Procedure: Femoral with Tibial Nerve BlockContinuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa |
| Canal Block and Capsular Injection | Experimental | Procedure: Canal Block and Capsular InjectionAdductor canal block with a continuous catheter and ultrasound guided posterior capsular injection with local anesthetic solution. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients having primary, unilateral total knee arthroplasty
- ages 18 - 80
Key exclusion criteria (9 listed)
- history of neurological disease
- neuropathy
- diabetes
- major systemic illness
- pregnancy
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 |
|---|---|---|
| Canal Block and Capsular InjectionContinuous Adductor canal block with 15-30ml of ropivacaine 0.1% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30 ml ropivacaine 0.1% with epinephrine 1:400,000. | Procedure or surgery | Canal Block and Capsular Injection |
| Femoral with Tibial Nerve BlockContinuous femoral nerve block with 15 ml of ropivacaine 0.1% followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.1% up to 15 ml. | Procedure or surgery | Femoral With Tibial Nerve Block |
Primary outcome
Ability to ambulate post operatively.
Time frame: Up to 3 days (72 hours) post surgery.
Ability to ambulate and perform tasks of the rehabilitation program and reach rehabilitation milestones after total knee arthroplasty.
2 secondary outcomes
Pain scores at rest and with knee flexion.
Time frame: Up to 3 days ( 72 hours) after surgery
Pain Medication Consumption
Time frame: Up to 3 days (72 hours) post surgery
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 17 Mar 2015.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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 Sinha, M.D. principal investigator
Saint Francis Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canal Block and Capsular Injection and Femoral with Tibial Nerve Block in people with Pain and Osteoarthritis, run by Trinity Health Of New England at 1 site in United States.
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 2 inclusion and 9 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 17 Mar 2015. 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 United States. 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?
Ability to ambulate post operatively. (time frame: Up to 3 days (72 hours) post surgery.). 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 17 Mar 2015.