Post-operative Pain, AcuteNCT05004636
Adductor Canal Blocks With Bupivacaine and Magnesium After Same-day Discharge Total Knee Arthroplasty Improve Post-operative Pain Relief and Decrease Opioid Consumption: a Prospective Randomized Controlled Trial
A study testing Adding Magnesium as an adjuvant to the adductor canal Block (ACB) for same-day discharge total knee arthroplasty in people with Post-operative Pain, Acute, run by Wayne State University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the addition of magnesium to bupivacaine for the post-operative adductor canal blocks (ACB) can decrease opioid consumption and improve pain management for patients after same-day discharge total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post-operative Pain, Acute
- What is being tested?
- Adding Magnesium as an adjuvant to the adductor canal Block (ACB) for same-day discharge total knee arthroplasty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2020to 29 May 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral primary total knee arthroplasty with spinal anesthetic and MAC followed by a unilateral adductor canal block with ultrasound guidance.
Who cannot join
- Patients on chronic anticoagulation upon admission
- Patients with significant genetic or acquired clotting/bleeding disorders (hemophilia, DIC, etc.) or significant platelet dysfunction
- Patients with prior back surgery or leg surgery that precludes spinal or regional anesthesia
- Infection at sites for regional/spinal anesthesia
- Allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
About this study
The purpose of this study is to determine whether the addition of magnesium to bupivacaine for the post-operative adductor canal blocks (ACB) can decrease opioid consumption and improve pain management for patients after same-day discharge total knee arthroplasty (TKA).
The investigators will assess whether the addition of magnesium will decrease visual analog scale (VAS) pain scores, decrease post-operative total opioid consumption (oral morphine equivalents), decrease the incidence of post-operative nausea and vomiting (PONV), and improve patient satisfaction in comparison to when magnesium is not administered.
Read the detailed description
Total knee arthroplasty (TKA) is one of the most common elective surgical procedures in the United States . The number of TKA procedures has doubled in each of the past two decades and is expected to top 3.4 million per year in the United States by 2030.
Within the last 10-15 years significant changes have taken place in the anesthetic management of patients undergoing total knee arthroplasty (TKA). In the past, the majority of patients underwent general anesthesia and were managed post-operatively with a PCA (patient controlled analgesia) pump.
More recently anesthesiologists have begun to use neuraxial anesthesia (spinal anesthesia) combined with regional anesthesia (peripheral nerve block (PNB)) techniques combined with monitored anesthesia care (MAC) for many of these surgeries.
Regional anesthesia is used to block the sensation in a specific part of body during and after surgery. It offers numerous advantages over conventional general anesthesia, including faster recovery time, fewer side effects, no need for an airway device during surgery, and a dramatic reduction in post-surgical pain and reduction in opioid use following surgery. The use of local anesthetic peripheral nerve blocks for surgical anesthesia and postoperative pain management has increased significantly with the advent of ultrasound-guided techniques.
However, the duration of traditional amide-based and ester-based regional anesthesia is normally limited to only a few hours. Techniques including continuous catheter placement or serial injections can be used to enhance the duration and effect of regional anesthesia for postoperative pain control. But these approaches can increase the risk of infection, toxicity, and cost. Therefore, alternative methods of extending the clinical duration of nerve blocks have been a topic of significant interest.
Magnesium sulfate, an NMDA receptor antagonist, exerts it analgesic effects by at least two mechanisms: it acts as a physiological calcium antagonist by blocking NMDA receptors and it inhibits the inflammatory response through the reduction of inflammatory cytokines.
Magnesium has also been shown to decrease peripheral nerve excitability. Addition of magnesium to intravenous regional anesthesia for chronic limb pain management has demonstrated improvement in quality of blockade and prolonged the duration of analgesia. Magnesium decreased intraoperative opioid consumption and tourniquet pain. Magnesium improved the quality of anesthesia and prolonged the time for first postoperative analgesic requirement. Overall, the addition of magnesium to local anesthetic is effective both for perineural (nerve blocks) and intravenous regional anesthesia.
In a recent meta-analysis of randomized controlled trials, Li et al. evaluated seven trials involving 493 patients. Investigators concluded that the addition of magnesium as an adjuvant to PNB prolonged the postoperative duration time of analgesia, sensory, and motor block.
Studies have consistently shown that addition of magnesium to local anesthetic significantly prolongs peripheral nerve blocks, including femoral nerve blocks with bupivacaine, interscalene blocks with bupivacaine, and axillary blocks with prilocaine and levobupivacaine. All of these papers denied adjuvant-related toxicity or side effects; however, nausea was two to three times more likely in the first 12 hours after interscalene blocks with 200mg magnesium in the study by Lee et al. This side effect was not reported in studies using 150mg magnesium.
The purpose of this study is to determine whether the addition of magnesium to bupivacaine for the post-operative adductor canal blocks can decrease opioid consumption and improve pain management for patients after total knee arthroplasty (TKA).
The investigators will assess whether the addition of magnesium will decrease visual analog scale (VAS) pain scores, decrease post-operative total opioid consumption (oral morphine equivalents), decrease the incidence of post-operative nausea and vomiting (PONV), and improve patient satisfaction in comparison to when magnesium is not administered.
- Conditions
- Post-operative Pain, Acute
- Being tested
- Adding Magnesium as an adjuvant to the adductor canal Block (ACB) for same-day discharge total knee arthroplasty
- Keywords
- Same-day discharge total knee arthroplasty; Magnesium; Adductor canal block; Post-operative opioid consumption; Post-operative pain management
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adding Magnesium as an adjuvant to the adductor canal Block (ACB) for same-day discharge total knee arthroplastyDrug
Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Half of the patients (selected randomly using random number table) will receive 150mg of magnesium sulfate (0.3mL) in the block and the other half will receive 0.3 mL of saline in the block.
| Study group | Role | What they receive |
|---|---|---|
| No_Mg | No intervention | Ctrl Group. Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Patients in this Arm (selected randomly) will not receive Mg (the intervention) in the block; instead they will receive 0.3mL of sterile saline. |
| Mg | Experimental | Treatment Group. Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Patients in this Arm (selected randomly) will receive 150 mg Mg (0.3 mL-the intervention) in the block. Receives: Drug: Adding Magnesium as an adjuvant to the adductor canal Block (ACB) for same-day discharge total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption (oral morphine equivalents) in the first 24 hours after surgery
Measuring the post surgical total opioid consumption in the first 24 hours after surgery by calculating oral morphine equivalents (mg)
Measured: The first 24 hours after surgery
Total opioid consumption (oral morphine equivalents) in the second 24 hours after surgery
Measuring the post surgical total opioid consumption in the second 24 hours after surgery by calculating oral morphine equivalents (mg)
Measured: The second 24 hours after surgery
Visual analog scale (VAS) pain score at 24 hours after surgery
Determining pain scores using Visual analog scale (VAS) at 24 hours after surgery (0-10, Higher scores mean worse outcome)
Measured: 24 hours after surgery
Visual analog scale (VAS) pain score at 48 hours after surgery
Determining pain scores using Visual analog scale (VAS) at 48 hours after surgery (0-10, Higher scores mean worse outcome)
Measured: 48 hours after surgery
Secondary outcomes (2)
Percentage of incidence of post-operative nausea/ vomiting in first 48 hours after surgery
The incidence of nausea or vomiting in the first 48 hours after surgery is recorded
Measured: First 48 hours after surgery
Overall patient satisfaction in first 48 hours after surgery
Patient satisfaction scores averaged over the first 48 hours after surgery (0-10, higher scores are better)
Measured: First 48 hours after surgery
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 start5 Aug 2020
- Primary completion29 May 2021
- Study completion29 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Pain, AcuteStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandeep Krishnan, Wayne State University
- Investigators
- Sandeep Krishnan, MD, Principal investigator, Wayne State University School of Medicine Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004636
- Sponsor's protocol ID
- Mg_in_TKA
- Status last verified
- Aug 2021
- First submitted
- 30 Jul 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Blocks With Bupivacaine and Magnesium After Same-day Discharge Total Knee Arthroplasty Improve Post-operative Pain Relief and Decrease Opioid Consumption: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05004636
- Acronym / sponsor ID
- Mg_in_TKA
- Conditions
- Post-operative Pain, Acute
- Keywords
- Same-day discharge total knee arthroplasty; Magnesium; Adductor canal block; Post-operative opioid consumption; Post-operative pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 29 May 2021 (actual)
- Study completion
- 29 May 2021 (actual)
- 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.
The purpose of this study is to determine whether the addition of magnesium to bupivacaine for the post-operative adductor canal blocks (ACB) can decrease opioid consumption and improve pain management for patients after same-day discharge total knee arthroplasty (TKA).
The investigators will assess whether the addition of magnesium will decrease visual analog scale (VAS) pain scores, decrease post-operative total opioid consumption (oral morphine equivalents), decrease the incidence of post-operative nausea and vomiting (PONV), and improve patient satisfaction in comparison to when magnesium is not administered.
Detailed description
Total knee arthroplasty (TKA) is one of the most common elective surgical procedures in the United States . The number of TKA procedures has doubled in each of the past two decades and is expected to top 3.4 million per year in the United States by 2030.
Within the last 10-15 years significant changes have taken place in the anesthetic management of patients undergoing total knee arthroplasty (TKA). In the past, the majority of patients underwent general anesthesia and were managed post-operatively with a PCA (patient controlled analgesia) pump.
More recently anesthesiologists have begun to use neuraxial anesthesia (spinal anesthesia) combined with regional anesthesia (peripheral nerve block (PNB)) techniques combined with monitored anesthesia care (MAC) for many of these surgeries.
Regional anesthesia is used to block the sensation in a specific part of body during and after surgery. It offers numerous advantages over conventional general anesthesia, including faster recovery time, fewer side effects, no need for an airway device during surgery, and a dramatic reduction in post-surgical pain and reduction in opioid use following surgery. The use of local anesthetic peripheral nerve blocks for surgical anesthesia and postoperative pain management has increased significantly with the advent of ultrasound-guided techniques.
However, the duration of traditional amide-based and ester-based regional anesthesia is normally limited to only a few hours. Techniques including continuous catheter placement or serial injections can be used to enhance the duration and effect of regional anesthesia for postoperative pain control. But these approaches can increase the risk of infection, toxicity, and cost. Therefore, alternative methods of extending the clinical duration of nerve blocks have been a topic of significant interest.
Magnesium sulfate, an NMDA receptor antagonist, exerts it analgesic effects by at least two mechanisms: it acts as a physiological calcium antagonist by blocking NMDA receptors and it inhibits the inflammatory response through the reduction of inflammatory cytokines.
Magnesium has also been shown to decrease peripheral nerve excitability. Addition of magnesium to intravenous regional anesthesia for chronic limb pain management has demonstrated improvement in quality of blockade and prolonged the duration of analgesia. Magnesium decreased intraoperative opioid consumption and tourniquet pain. Magnesium improved the quality of anesthesia and prolonged the time for first postoperative analgesic requirement. Overall, the addition of magnesium to local anesthetic is effective both for perineural (nerve blocks) and intravenous regional anesthesia.
In a recent meta-analysis of randomized controlled trials, Li et al. evaluated seven trials involving 493 patients. Investigators concluded that the addition of magnesium as an adjuvant to PNB prolonged the postoperative duration time of analgesia, sensory, and motor block.
Studies have consistently shown that addition of magnesium to local anesthetic significantly prolongs peripheral nerve blocks, including femoral nerve blocks with bupivacaine, interscalene blocks with bupivacaine, and axillary blocks with prilocaine and levobupivacaine. All of these papers denied adjuvant-related toxicity or side effects; however, nausea was two to three times more likely in the first 12 hours after interscalene blocks with 200mg magnesium in the study by Lee et al. This side effect was not reported in studies using 150mg magnesium.
The purpose of this study is to determine whether the addition of magnesium to bupivacaine for the post-operative adductor canal blocks can decrease opioid consumption and improve pain management for patients after total knee arthroplasty (TKA).
The investigators will assess whether the addition of magnesium will decrease visual analog scale (VAS) pain scores, decrease post-operative total opioid consumption (oral morphine equivalents), decrease the incidence of post-operative nausea and vomiting (PONV), and improve patient satisfaction in comparison to when magnesium is not administered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No_Mg | No intervention | –Ctrl Group. Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Patients in this Arm (selected randomly) will not receive Mg (the intervention) in the block; instead they will receive 0.3mL of sterile saline. |
| Mg | Experimental | Drug: Adding Magnesium as an adjuvant to the adductor canal Block (ACB) for same-day discharge total knee arthroplastyTreatment Group. Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Patients in this Arm (selected randomly) will receive 150 mg Mg (0.3 mL-the intervention) in the block. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing unilateral primary total knee arthroplasty with spinal anesthetic and MAC followed by a unilateral adductor canal block with ultrasound guidance.
Key exclusion criteria (5 listed)
- Patients on chronic anticoagulation upon admission
- Patients with significant genetic or acquired clotting/bleeding disorders (hemophilia, DIC, etc.) or significant platelet dysfunction
- Patients with prior back surgery or leg surgery that precludes spinal or regional anesthesia
- Infection at sites for regional/spinal anesthesia
- Allergy to local anesthetics
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 |
|---|---|---|
| Adding Magnesium as an adjuvant to the adductor canal Block (ACB) for same-day discharge total knee arthroplastyPost-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Half of the patients (selected randomly using random number table) will receive 150mg of magnesium sulfate (0.3mL) in the block and the other half will receive 0.3 mL of saline in the block. | Drug | Mg |
Primary outcome
Total opioid consumption (oral morphine equivalents) in the first 24 hours after surgery
Time frame: The first 24 hours after surgery
Measuring the post surgical total opioid consumption in the first 24 hours after surgery by calculating oral morphine equivalents (mg)
Total opioid consumption (oral morphine equivalents) in the second 24 hours after surgery
Time frame: The second 24 hours after surgery
Measuring the post surgical total opioid consumption in the second 24 hours after surgery by calculating oral morphine equivalents (mg)
Visual analog scale (VAS) pain score at 24 hours after surgery
Time frame: 24 hours after surgery
Determining pain scores using Visual analog scale (VAS) at 24 hours after surgery (0-10, Higher scores mean worse outcome)
Visual analog scale (VAS) pain score at 48 hours after surgery
Time frame: 48 hours after surgery
Determining pain scores using Visual analog scale (VAS) at 48 hours after surgery (0-10, Higher scores mean worse outcome)
2 secondary outcomes
Percentage of incidence of post-operative nausea/ vomiting in first 48 hours after surgery
Time frame: First 48 hours after surgery
Overall patient satisfaction in first 48 hours after surgery
Time frame: First 48 hours after 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 13 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Sandeep Krishnan, MD principal investigator
Wayne State University School of Medicine Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adding Magnesium as an adjuvant to the adductor canal Block (ACB) for same-day discharge total knee arthroplasty in people with Post-operative Pain, Acute, run by Wayne State 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 1 inclusion and 5 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 13 Aug 2021. 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?
Total opioid consumption (oral morphine equivalents) in the first 24 hours after surgery (time frame: The first 24 hours after surgery). The study lists 4 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 13 Aug 2021.