Knee OsteoarthritisPhase 4NCT05974501

Pre vs Post Block in Total Knee Arthroplasty (TKA)

A Phase 4 study testing Dexamethasone, Acetaminophen and Lyrica in people with Knee Osteoarthritis and Arthroplasty Complications, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee arthroplasty can be observed with the substitution of a post operative adductor canal block for a preoperative adductor canal block in the current established peri-operative pain protocol and if these… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Knee Osteoarthritis, Arthroplasty Complications, Postoperative Pain
What is being tested?: Dexamethasone, Acetaminophen and Lyrica
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteUnited States
Study dates: 29 Sep 2023to 22 Jan 2024
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1- Patients 18 or older 2 - Patients undergoing primary total knee replacement at the University of Miami Hospital 3 - Patients that have capacity to provide medical consent

Who cannot join

All patients under the age of 18
Prisoners, uncontrolled diabetics, increased risk of bleeding, pregnant women, women planning on becoming pregnant in the next year, and women who think they might be pregnant.
Patients with prior surgery or history of infection on the joint of interest.
Patients on steroid preoperatively.
Inability to provide medical consent.
Patients with a history of significant unmitigated pain in parts of their body not including the knee the procedure is to be performed or a history of pain catastrophizing (the tendency to magnify the threat value of the pain stimulus and to feel helpless in the context of pain, and by a relative inability to inhibit pain-related thoughts in anticipation of, during or following a painful event) regarding pain anywhere in the body.
Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements will exclude the participant.
Allergy to local anesthetic or any medication used in the standard protocol for joint replacement.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami
Miami, Florida, 33136

Other trials in United States

About this study

Official title: Pre vs. Postoperative Adductor Canal Block for Total Knee Arthroplasty: Prospective Randomized Trial

Conditions: Knee Osteoarthritis, Arthroplasty Complications, Postoperative Pain
Being tested: Dexamethasone, Acetaminophen, Lyrica, Celebrex, Meloxicam
Medical subject headings: Osteoarthritis, Knee, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexamethasoneDrug
Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling
AcetaminophenDrug
1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively
LyricaDrug
Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively
CelebrexDrug
200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively
MeloxicamDrug
30mg administered via IV once postoperatively within 24 hours for pain and swelling
OxycodoneDrug
5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively
RopivacaineDrug
Also called Adductor Canal Block
20 milliliters Ropivacaine 0.2% administered via injection perioperatively.

Study groups in NCT05974501
Study group	Role	What they receive
Preoperative Adductor Canal Block Group	Active comparator	Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery. Receives: Drug: Dexamethasone; Drug: Acetaminophen; Drug: Lyrica; Drug: Celebrex; Drug: Meloxicam; Drug: Oxycodone; Drug: Ropivacaine
Postoperative Adductor Canal Block Group	Experimental	Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours Receives: Drug: Dexamethasone; Drug: Acetaminophen; Drug: Lyrica; Drug: Celebrex; Drug: Meloxicam; Drug: Oxycodone; Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Status as Measured by Numeric Pain Scale
Scale with numeric scores ranging from 0 (least) to 10 (most) pain
Measured: 2 hours postoperatively
Pain Status as Measured by Numeric Pain Scale
Scale with numeric scores ranging from 0 (least) to 10 (most) pain
Measured: 24 hours postoperatively

Secondary outcomes (14)

Patients Reporting Nausea
Count of the number of patients reporting nausea
Measured: 2 hours postoperatively
Episodes of Nausea
Count of the number of episodes of nausea per patient
Measured: 2 hours postoperatively
Patients Reporting Nausea
Count of the number of patients reporting nausea
Measured: 24 hours postoperatively
Episodes of Nausea
Count of the number of episodes of nausea per patient
Measured: 24 hours postoperatively
Patients Reporting Vomiting
Count of the number of patients reporting vomiting
Measured: 2 hours postoperatively
Episodes of Vomiting
Count of the number of episodes of vomiting per patient
Measured: 2 hours postoperatively
Patients Reporting Vomiting
Count of the number of patients reporting vomiting
Measured: 24 hours postoperatively
Episodes of Vomiting
Count of the number of episodes of vomiting per patient
Measured: 24 hours postoperatively
Total Opioid Consumption
Measure of the amount of morphine milliequivalents consumed by the patient
Measured: 2 hours postoperatively
Total Opioid Consumption
Measure of the amount of morphine milliequivalents consumed by the patient
Measured: 24 hours postoperatively
Nights Hospitalized
Number of nights hospitalized
Measured: Up to 14 nights postoperatively
Hours Hospitalized
Number of hours hospitalized
Measured: Up to 336 hours postoperatively
Discharges by Midnight POD0
The number of patients discharged home by midnight on postoperative day zero
Measured: Up to 24 hours postoperatively
Discharges by Midnight on POD1
The number of patients discharged home by midnight postoperative day one
Measured: Up to 48 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 202322 Jan 2024

First posted3 Aug 2023
Study start29 Sep 2023
Primary completion22 Jan 2024
Study completion22 Jan 2024

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.
Other trials for Knee OsteoarthritisStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05974501
Sponsor's protocol ID: 20230147
Status last verified: Jan 2025
First submitted: 26 Jul 2023
Last updated: 12 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pre vs. Postoperative Adductor Canal Block for Total Knee Arthroplasty: Prospective Randomized Trial
ClinicalTrials.gov ID: NCT05974501
Acronym / sponsor ID: 20230147
Conditions: Knee Osteoarthritis, Arthroplasty Complications, Postoperative Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: 29 Sep 2023 (actual)
Primary completion: 22 Jan 2024 (actual)
Study completion: 22 Jan 2024 (actual)
First posted: 3 Aug 2023 (actual)
Results: Posted 12 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Preoperative Adductor Canal Block Group	Active comparator	Drug: Dexamethasone, Drug: Acetaminophen, Drug: Lyrica, Drug: Celebrex, Drug: Meloxicam, Drug: Oxycodone, Drug: RopivacaineParticipants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery.
Postoperative Adductor Canal Block Group	Experimental	Drug: Dexamethasone, Drug: Acetaminophen, Drug: Lyrica, Drug: Celebrex, Drug: Meloxicam, Drug: Oxycodone, Drug: RopivacaineParticipants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1- Patients 18 or older 2 - Patients undergoing primary total knee replacement at the University of Miami Hospital 3 - Patients that have capacity to provide medical consent

Key exclusion criteria (8 listed)

All patients under the age of 18
Prisoners, uncontrolled diabetics, increased risk of bleeding, pregnant women, women planning on becoming pregnant in the next year, and women who think they might be pregnant.
Patients with prior surgery or history of infection on the joint of interest.
Patients on steroid preoperatively.
Inability to provide medical consent.

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
DexamethasoneDexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling	Drug	Postoperative Adductor Canal Block Group, Preoperative Adductor Canal Block Group
Acetaminophen1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively	Drug	Postoperative Adductor Canal Block Group, Preoperative Adductor Canal Block Group
LyricaAdministered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively	Drug	Postoperative Adductor Canal Block Group, Preoperative Adductor Canal Block Group
Celebrex200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively	Drug	Postoperative Adductor Canal Block Group, Preoperative Adductor Canal Block Group
Meloxicam30mg administered via IV once postoperatively within 24 hours for pain and swelling	Drug	Postoperative Adductor Canal Block Group, Preoperative Adductor Canal Block Group
Oxycodone5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively	Drug	Postoperative Adductor Canal Block Group, Preoperative Adductor Canal Block Group
RopivacaineAlso: Adductor Canal Block20 milliliters Ropivacaine 0.2% administered via injection perioperatively.	Drug	Postoperative Adductor Canal Block Group, Preoperative Adductor Canal Block Group

Primary outcome

Pain Status as Measured by Numeric Pain Scale
Time frame: 2 hours postoperatively
Scale with numeric scores ranging from 0 (least) to 10 (most) pain
Pain Status as Measured by Numeric Pain Scale
Time frame: 24 hours postoperatively
Scale with numeric scores ranging from 0 (least) to 10 (most) pain

14 secondary outcomes

Patients Reporting Nausea
Time frame: 2 hours postoperatively
Episodes of Nausea
Time frame: 2 hours postoperatively
Patients Reporting Nausea
Time frame: 24 hours postoperatively
Episodes of Nausea
Time frame: 24 hours postoperatively
Patients Reporting Vomiting
Time frame: 2 hours postoperatively
Episodes of Vomiting
Time frame: 2 hours postoperatively
Patients Reporting Vomiting
Time frame: 24 hours postoperatively
Episodes of Vomiting
Time frame: 24 hours postoperatively
Total Opioid Consumption
Time frame: 2 hours postoperatively
Total Opioid Consumption
Time frame: 24 hours postoperatively
Nights Hospitalized
Time frame: Up to 14 nights postoperatively
Hours Hospitalized
Time frame: Up to 336 hours postoperatively
Discharges by Midnight POD0
Time frame: Up to 24 hours postoperatively
Discharges by Midnight on POD1
Time frame: Up to 48 hours postoperatively

Results and safety

Results posted to the registry on 12 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Preoperative Adductor Canal Block Group	46	46
Postoperative Adductor Canal Block Group	38	37

Primary outcome: Pain Status as Measured by Numeric Pain Scale

Time frame: 2 hours postoperatively. Median (95% Confidence Interval). Unit: score on a scale

Measure	Preoperative Adductor Canal Block Group n = 46	Postoperative Adductor Canal Block Group n = 37
Value	2 (1.00 to 6.00)	4.00 (1.00 to 5.00)

Population analysed: Patients who completed the study in one of the two groups

Primary outcome: Pain Status as Measured by Numeric Pain Scale

Time frame: 24 hours postoperatively. Median (95% Confidence Interval). Unit: score on a scale

Measure	Preoperative Adductor Canal Block Group n = 46	Postoperative Adductor Canal Block Group n = 37
Value	6.00 (4.00 to 7.00)	6.00 (5.00 to 8.00)

Population analysed: Patients who completed the study in one of the two groups

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hours postoperatively. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Preoperative Adductor Canal Block Group	0 of 46 (0%)	0 of 46 (0%)	0 of 46
Postoperative Adductor Canal Block Group	0 of 38 (0%)	0 of 38 (0%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Knee Osteoarthritis

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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.

Victor H. Hernandez, MD principal investigator

University of Miami

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 Dexamethasone, Acetaminophen and Lyrica in people with Knee Osteoarthritis and Arthroplasty Complications, run by University of Miami 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 1 inclusion and 8 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 12 Feb 2025. 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 12 Feb 2025). 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?

Pain Status as Measured by Numeric Pain Scale (time frame: 2 hours postoperatively). The study lists 2 primary outcomes in all. 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 NCT05974501.

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 12 Feb 2025.