Postoperative PainPhase 4NCT01163214
Management of Postoperative Pain After Total Knee Replacement.
A Phase 4 study testing Nerve Block and Periarticular Injection in people with Postoperative Pain and Knee Replacement Arthroplasty, run by Mark J. Spangehl, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Postoperative Pain, Knee Replacement Arthroplasty
- What is being tested?
- Nerve Block and Periarticular Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral primary total knee replacement.
- Weight 50-125 kg.
- Age 18-79 years.
- Intact neurological exam to the surgical lower extremity.
- Cognitively intact with ability to sign informed consent.
Who cannot join
- Renal insufficiency with creatinine >1.5 mg/dL.
- Allergy to medication used in the study.
- Using narcotic medication prior to surgery (morphine equivalents >=20 mg/day for >7 days.)
- Prior open knee surgery with regional anesthesia or periarticular injection for post-operative pain management.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Postoperative Pain After Total Knee Replacement.
The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement.
Read the detailed description
Patients undergoing total knee replacement will be assigned at random to receive one of two methods of postoperative pain management. Patients assigned to nerve block will receive regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block. Patients assigned to periarticular injection will receive periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Additionally, all patients will be given a standardized combination of oral analgesic medications preoperatively and postoperatively. All patients will receive a posterior stabilized total knee replacement through an medial parapatellar approach.
- Conditions
- Postoperative Pain, Knee Replacement Arthroplasty
- Being tested
- Nerve Block, Periarticular Injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve BlockDrug
Also called Naropin
Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.
Periarticular InjectionDrug
Also called Naropin, Adrenalin, Toradol
Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
| Study group | Role | What they receive |
|---|---|---|
| Nerve Block | Experimental | Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Receives: Drug: Nerve Block |
| Periarticular Injection | Active comparator | Injection combination prior to skin closure. Receives: Drug: Periarticular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Pain
Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).
Measured: Afternoon on post-operative Day 1, approximately 14:00
Secondary outcomes (5)
Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)
Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).
Measured: Afternoon on post-operative Day 1, approximately 14:00
Narcotic Use
Use of additional narcotic medications (as needed), measured in morphine equivalents.
Measured: Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2
Straight-leg Raise
Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.
Measured: Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon
Length of Stay in Hospital
Length of stay data were calculated from the medical record.
Measured: Approximately 2 days after surgery
Number of Subjects Who Experienced Neurological Changes Postoperatively
Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.
Measured: 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark J. Spangehl, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark J. Spangehl, M.D., Mayo Clinic
- Investigators
- Mark J Spangehl, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163214
- Sponsor's protocol ID
- 10-003312
- Other IDs
- UL1TR000135
- Status last verified
- Nov 2014
- First submitted
- 14 Jul 2010
- Last updated
- 5 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Spangehl MJ, Clarke HD, Hentz JG, Misra L, Blocher JL, Seamans DP. The Chitranjan Ranawat Award: Periarticular injections and femoral & sciatic blocks provide similar pain relief after TKA: a randomized clinical trial. Clin Orthop Relat Res. 2015 Jan;473(1):45-53. doi: 10.1007/s11999-014-3603-0.
PubMed 24706022
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Postoperative Pain After Total Knee Replacement.
- ClinicalTrials.gov ID
- NCT01163214
- Acronym / sponsor ID
- 10-003312
- Conditions
- Postoperative Pain, Knee Replacement Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mark J. Spangehl, M.D.University, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Posted 5 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement.
Detailed description
Patients undergoing total knee replacement will be assigned at random to receive one of two methods of postoperative pain management. Patients assigned to nerve block will receive regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block. Patients assigned to periarticular injection will receive periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Additionally, all patients will be given a standardized combination of oral analgesic medications preoperatively and postoperatively. All patients will receive a posterior stabilized total knee replacement through an medial parapatellar approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve Block | Experimental | Drug: Nerve BlockPreoperative femoral block with indwelling femoral catheter and a single shot sciatic block. |
| Periarticular Injection | Active comparator | Drug: Periarticular InjectionInjection combination prior to skin closure. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral primary total knee replacement.
- Weight 50-125 kg.
- Age 18-79 years.
- Intact neurological exam to the surgical lower extremity.
- Cognitively intact with ability to sign informed consent.
Key exclusion criteria (4 listed)
- Renal insufficiency with creatinine >1.5 mg/dL.
- Allergy to medication used in the study.
- Using narcotic medication prior to surgery (morphine equivalents >=20 mg/day for >7 days.)
- Prior open knee surgery with regional anesthesia or periarticular injection for post-operative pain management.
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 |
|---|---|---|
| Nerve BlockAlso: NaropinRegional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine. | Drug | Nerve Block |
| Periarticular InjectionAlso: Naropin, Adrenalin, ToradolPeriarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories. | Drug | Periarticular Injection |
Primary outcome
Post-Operative Pain
Time frame: Afternoon on post-operative Day 1, approximately 14:00
Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).
5 secondary outcomes
Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)
Time frame: Afternoon on post-operative Day 1, approximately 14:00
Narcotic Use
Time frame: Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2
Straight-leg Raise
Time frame: Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon
Length of Stay in Hospital
Time frame: Approximately 2 days after surgery
Number of Subjects Who Experienced Neurological Changes Postoperatively
Time frame: 6 weeks postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24706022Spangehl MJ, Clarke HD, Hentz JG, Misra L, Blocher JL, Seamans DP. The Chitranjan Ranawat Award: Periarticular injections and femoral & sciatic blocks provide similar pain relief after TKA: a randomized clinical trial. Clin Orthop Relat Res. 2015 Jan;473(1):45-53. doi: 10.1007/s11999-014-3603-0.
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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.
Mark J Spangehl, M.D. principal investigator
Mayo Clinic
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 Nerve Block and Periarticular Injection in people with Postoperative Pain and Knee Replacement Arthroplasty, run by Mark J. Spangehl, M.D. 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 5 inclusion and 4 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 5 Nov 2014. 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.
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?
Yes. Results are posted in the registry (first posted 5 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-Operative Pain (time frame: Afternoon on post-operative Day 1, approximately 14:00). 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 NCT01163214, 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 5 Nov 2014.