Pain, PostoperativePhase 4NCT03864588
Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist
A Phase 4 study testing Ropivacaine in people with Pain, Postoperative and Satisfaction, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of two methods of administering an adductor canal block (ACB) following total knee arthroplasty (TKA); intraoperative surgeon performed intra-articular adductor canal block (IACB) and anesthesiologist ultrasound guided ADC in the post-anesthesia recovery unit… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Satisfaction
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to Sep 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis
- ASA I - III
- Spinal anesthesia
- All patients will have cemented total knee utilizing a medial parapatellar approach with posterior stabilized or cruciate retaining implants. A tourniquet will be used in all cases.
- Patients must be between 18 and 80 years of age.
- Active and valid email address for the participant.
Who cannot join
- Allergy to anesthetics or study analgesic medications.
- Contraindication to regional anesthesia
- Non-english speaking
- ASA IV or greater
- Renal insufficiency with Cr > 2.0 or hepatic failure
- General or epidural anesthesia
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- Sensory/motor disorder involving the operative limb
- Patients who consume preoperative opioids for pain control.
- Pregnant women
- Mentally disabled patients and patients with psychiatric disorders that would prevent them from properly understanding and evaluating an informed consent process.
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Intraoperative Surgeon-Performed Versus Anesthesiologist-Performed Adductor Canal Blockade After Primary Total Knee Arthroplasty
The purpose of this study is to evaluate the efficacy of two methods of administering an adductor canal block (ACB) following total knee arthroplasty (TKA); intraoperative surgeon performed intra-articular adductor canal block (IACB) and anesthesiologist ultrasound guided ADC in the post-anesthesia recovery unit (PACU).
- Conditions
- Pain, Postoperative, Satisfaction
- Being tested
- Ropivacaine
- Medical subject headings
- Pain, Postoperative, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
For primary TKA, Ropivacaine is used in both arms, either performed intra-operatively by surgeon or post-operatively (ultrasound guided) by anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Anesthesiologist preforms ultrasound guided adductor canal block post-operatively Receives: Drug: Ropivacaine |
| Intervention | Experimental | Surgeon preforms inter-operative adductor canal block Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analog scale pain score
The primary end point is the patients' reported visual analogue pain score (VAS). 0-100mm scale
Measured: Up to 6 weeks post-surgery
Secondary outcomes (3)
Change in range of motion
Range of motion
Measured: up to 6 weeks post-surgery
Change in timed up and go
Timed up and go
Measured: up to 6 weeks post-surgery
Change in daily opioid consumption
daily opioid consumption
Measured: up to 6 weeks 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 2019
- Study start1 Oct 2018
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Collaborators
- Sharpe-Strumia Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864588
- Sponsor's protocol ID
- 2018LonnerSS
- Status last verified
- Mar 2019
- First submitted
- 26 Oct 2018
- Last updated
- 6 Mar 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Intraoperative Surgeon-Performed Versus Anesthesiologist-Performed Adductor Canal Blockade After Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03864588
- Acronym / sponsor ID
- 2018LonnerSS
- Conditions
- Pain, Postoperative, Satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Collaborators
- Sharpe-Strumia Research Foundation
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 6 Mar 2019 (actual)
- 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 purpose of this study is to evaluate the efficacy of two methods of administering an adductor canal block (ACB) following total knee arthroplasty (TKA); intraoperative surgeon performed intra-articular adductor canal block (IACB) and anesthesiologist ultrasound guided ADC in the post-anesthesia recovery unit (PACU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: RopivacaineAnesthesiologist preforms ultrasound guided adductor canal block post-operatively |
| Intervention | Experimental | Drug: RopivacaineSurgeon preforms inter-operative adductor canal block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis
- ASA I - III
- Spinal anesthesia
- All patients will have cemented total knee utilizing a medial parapatellar approach with posterior stabilized or cruciate retaining implants. A tourniquet will be used in all cases.
- Patients must be between 18 and 80 years of age.
Key exclusion criteria (11 listed)
- Allergy to anesthetics or study analgesic medications.
- Contraindication to regional anesthesia
- Non-english speaking
- ASA IV or greater
- Renal insufficiency with Cr > 2.0 or hepatic failure
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 |
|---|---|---|
| RopivacaineFor primary TKA, Ropivacaine is used in both arms, either performed intra-operatively by surgeon or post-operatively (ultrasound guided) by anesthesiologist. | Drug | Control, Intervention |
Primary outcome
Change in visual analog scale pain score
Time frame: Up to 6 weeks post-surgery
The primary end point is the patients' reported visual analogue pain score (VAS). 0-100mm scale
3 secondary outcomes
Change in range of motion
Time frame: up to 6 weeks post-surgery
Change in timed up and go
Time frame: up to 6 weeks post-surgery
Change in daily opioid consumption
Time frame: up to 6 weeks post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ropivacaine in people with Pain, Postoperative and Satisfaction, run by Rothman Institute Orthopaedics 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 6 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 6 Mar 2019. 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. Some participants in this study may receive a placebo. 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?
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?
Change in visual analog scale pain score (time frame: Up to 6 weeks 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 6 Mar 2019.