Post-Operative Pain, ChronicPhase 3NCT05004506
Intra-articular Analgesia Versus Adductor Canal Block for Arthroscopic Knee Surgery
A Phase 3 study testing Adductor Canal Block and Intra-articular Injection in people with Post-Operative Pain, Chronic, run by Loyola University at 1 site in United States.
Trial summary
This study is a randomized study that compares two commonly used post-operative pain reducing techniques by measuring the level of pain and use of pain medication after knee surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Operative Pain, Chronic
- What is being tested?
- Adductor Canal Block and Intra-articular Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2016to 31 Dec 2022
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III patients
- Age 18 to 65 years
Who cannot join
- Allergy or intolerance to local anesthetics, NSAIDs, or opioids
- Inability to understand the consent or study process
- Any contraindication to regional anesthesia
- Known history of substance abuse
- Chronic home opioid therapy
- History of major neurologic deficit in operative limb
- Chronic pain syndromes
- Pregnancy and nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: A Prospective Randomized Controlled Trial of Intra-articular Analgesia Versus Adductor Canal Block for Arthroscopic Knee Surgery
This study is a randomized study that compares two commonly used post-operative pain reducing techniques by measuring the level of pain and use of pain medication after knee surgery.
Read the detailed description
Post-operative pain is a commonly associated with knee surgery. Treatment often includes an oral or intravenous (IV) narcotic regimen which often leads to nausea, vomiting and can cause consti-pation. These issues can contribute to the overall discomfort of the post-operative patient. Intra-operative injections and local nerve blocks have become common adjuncts to narcotics to reduce post-operative pain and the necessity for oral or IV narcotic use. The aim of this study is to com-pare analgesic use and clinical effects on post-operative pain management with intra-articular in-jection of 20ccs of 2% lidocaine with epinephrine at the start of the case plus 20ccs 0.5% mar-caine with epinephrine at the end of the case vs. adductor canal saphenous nerve blockade in pa-tients undergoing knee arthroscopy, as indicated by the need for rescue narcotics and patient pain scores. A randomized, single blinded study will be performed to evaluate post-operative pain control using VAS scores at 1, 2, 4, 8, 12, 24, 36, and 48hrs post-operatively, rescue narcotic use in the PACU, and total narcotic consumption over the same time period.
- Conditions
- Post-Operative Pain, Chronic
- Being tested
- Adductor Canal Block, Intra-articular 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.
Adductor Canal BlockDrug
The anesthesia provider will identify the adductor canal using ultrasound guidance and inject 15ccs of 0.5% marcaine with epinephrine around the saphenous nerve.
Intra-articular InjectionDrug
receive 20ccs of 2% lidocaine with epinephrine as an intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A patients will receive their treatment at the completion of the case while under general anesthesia. The anesthesia provider will identify the adductor canal using ultrasound guidance and inject 15ccs of 0.5% marcaine with epinephrine around the saphenous nerve.
Group A patients will receive placebo intra-articular and arthroscopic portal site saline injections equal in volume and procedure time point as the treatment in Group B.
At the completion of the case, the patient will be extubated and transferred to the PACU. Receives: Drug: Adductor Canal Block |
| Group B | Active comparator | Group B will receive 20ccs of 2% lidocaine with epinephrine as an intra-articular injection. At the completion of the arthroscopic procedure the patient will receive an additional 20ccs of 0.5% marcaine with epinephrine intra-articular injection.
Group B patients will also receive 10ccs of 2% lidocaine with epinephrine injected superficially into each of the arthroscopic portal sites. Group B patients will receive a 15cc saline injection around the saphenous nerve under the same procedure as the adductor canal block for Group A.
At the completion of the case, the patient will be extubated and transferred to the PACU. Receives: Drug: Intra-articular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic efficacy
VAS pain scores
Measured: 1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery
Rescue narcotics use
Opioid requirement due to pain
Measured: During post-surgical hospitalization
Total narcotic consumption
Opioid requirement overall
Measured: During post-surgical hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start20 Apr 2016
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative Pain, ChronicStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A will be for single shot adductor canal block. Group B will receive the intra-articular injection.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004506
- Sponsor's protocol ID
- LU208664
- Status last verified
- Apr 2022
- First submitted
- 11 Aug 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Intra-articular Analgesia Versus Adductor Canal Block for Arthroscopic Knee Surgery
- ClinicalTrials.gov ID
- NCT05004506
- Acronym / sponsor ID
- LU208664
- Conditions
- Post-Operative Pain, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 20 Apr 2016
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Aug 2021 (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.
This study is a randomized study that compares two commonly used post-operative pain reducing techniques by measuring the level of pain and use of pain medication after knee surgery.
Detailed description
Post-operative pain is a commonly associated with knee surgery. Treatment often includes an oral or intravenous (IV) narcotic regimen which often leads to nausea, vomiting and can cause consti-pation. These issues can contribute to the overall discomfort of the post-operative patient. Intra-operative injections and local nerve blocks have become common adjuncts to narcotics to reduce post-operative pain and the necessity for oral or IV narcotic use. The aim of this study is to com-pare analgesic use and clinical effects on post-operative pain management with intra-articular in-jection of 20ccs of 2% lidocaine with epinephrine at the start of the case plus 20ccs 0.5% mar-caine with epinephrine at the end of the case vs. adductor canal saphenous nerve blockade in pa-tients undergoing knee arthroscopy, as indicated by the need for rescue narcotics and patient pain scores. A randomized, single blinded study will be performed to evaluate post-operative pain control using VAS scores at 1, 2, 4, 8, 12, 24, 36, and 48hrs post-operatively, rescue narcotic use in the PACU, and total narcotic consumption over the same time period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group A will be for single shot adductor canal block. Group B will receive the intra-articular injection.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Adductor Canal BlockGroup A patients will receive their treatment at the completion of the case while under general anesthesia. The anesthesia provider will identify the adductor canal using ultrasound guidance and inject 15ccs of 0.5% marcaine with epinephrine around the saphenous nerve. Group A patients will receive placebo intra-articular and arthroscopic portal site saline injections equal in volume and procedure time point as the treatment in Group B. At the completion of the case, the patient will be extubated and transferred to the PACU. |
| Group B | Active comparator | Drug: Intra-articular InjectionGroup B will receive 20ccs of 2% lidocaine with epinephrine as an intra-articular injection. At the completion of the arthroscopic procedure the patient will receive an additional 20ccs of 0.5% marcaine with epinephrine intra-articular injection. Group B patients will also receive 10ccs of 2% lidocaine with epinephrine injected superficially into each of the arthroscopic portal sites. Group B patients will receive a 15cc saline injection around the saphenous nerve under the same procedure as the adductor canal block for Group A. At the completion of the case, the patient will be extubated and transferred to the PACU. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III patients
- Age 18 to 65 years
Key exclusion criteria (8 listed)
- Allergy or intolerance to local anesthetics, NSAIDs, or opioids
- Inability to understand the consent or study process
- Any contraindication to regional anesthesia
- Known history of substance abuse
- Chronic home opioid therapy
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 |
|---|---|---|
| Adductor Canal BlockThe anesthesia provider will identify the adductor canal using ultrasound guidance and inject 15ccs of 0.5% marcaine with epinephrine around the saphenous nerve. | Drug | Group A |
| Intra-articular Injectionreceive 20ccs of 2% lidocaine with epinephrine as an intra-articular injection | Drug | Group B |
Primary outcome
Analgesic efficacy
Time frame: 1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery
VAS pain scores
Rescue narcotics use
Time frame: During post-surgical hospitalization
Opioid requirement due to pain
Total narcotic consumption
Time frame: During post-surgical hospitalization
Opioid requirement overall
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Post-Operative Pain, Chronic
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
RecruitingObservational study
Quality of Life and Pain After Appendectomy in Children
Chronic Pain, Postoperative, Quality of Life
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative 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.
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 3 study testing Adductor Canal Block and Intra-articular Injection in people with Post-Operative Pain, Chronic, run by Loyola University 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 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: status not confirmed, as of the sponsor's last update on 12 Apr 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Analgesic efficacy (time frame: 1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery). The study lists 3 primary outcomes in all. 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 12 Apr 2022.