Pain ManagementPhase 1NCT05575999
Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain
A Phase 1 study testing Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination in people with Pain Management, run by Kansas City Heart Rhythm Research Foundation at 3 sites in United States.
Trial summary
Bupivacaine is the most widely used local anesthetic agent across majority of the Cardiac Implantable Electronic device (CIED) implant procedures in the United States. It is hypothesized that the combination of Bupivacaine-Ketorolac-Ketamine (BKK) is more effective in alleviating perioperative and postoperative pain… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both male and female patients
- Patients older than 18 years of age
- Patients undergoing new CIED (ICD, pacemaker, CRT-D or CRT-P)
- Patients willing to participate in the study
Who cannot join
- Patients with prior history of allergic reaction to any component of the drug; bupivacaine, ketorolac, or ketamine
- Pregnant or breastfeeding patients
- Prisoners
- Patients younger than 18 years of age
- Patients not willing to participate in the study
- Patients deemed not suitable or unstable for the study as per physician's discretion
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Loma Linda University Health
Loma Linda, California, 92350
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
About this study
Official title: Pain Management in Cardiac Implantable Electronic Device Insertion; Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain
Bupivacaine is the most widely used local anesthetic agent across majority of the Cardiac Implantable Electronic device (CIED) implant procedures in the United States. It is hypothesized that the combination of Bupivacaine-Ketorolac-Ketamine (BKK) is more effective in alleviating perioperative and postoperative pain as compared to the use of bupivacaine alone.
A few studies have been done to look for the effectiveness of BKK in abdominal surgical procedures. However, no study has been done to evaluate its efficacy and effectiveness in patients undergoing CIED insertion.
Read the detailed description
Bupivacaine is a widely used local anesthetic and is often administered by spinal injection prior to major surgical procedures. Ketorolac is a potent NSAID which is used for the short-term relief of moderate to severe pain. It's used for long term duration is generally limited due to its potential to cause GI ulcers/perforation and renal failure. A single dose of perioperative Ketorolac has been found to be effective in reducing opioid consumption. Ketamine is NMDA receptor antagonist and is used for its anesthetic, analgesic, and psychotomimetic effects. It is primarily used for induction and maintenance of anesthesia and induces a trance like state providing pain relief, sedation, and amnesia.
Although an effective local anesthetic agent, bupivacaine has weak analgesic effect and is used in combination with several analgesic agents for effective perioperative and postoperative analgesia. A common drug used in this analgesic regimen usually includes opioids such as morphine, oxycodone, and fentanyl. Over the last few decades the United States has witnessed an opioid epidemic and post-surgical opioid prescription is one of the major contributors of this epidemic. An opioid free combination of Bupivacaine-Ketorolac-Ketamine (BKK) is thought to be effective in alleviating perioperative and postoperative pain.
- Conditions
- Pain Management
- Being tested
- Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) CombinationDrug
The plan will be to stratify patients in two groups: intervention group receiving 20 cc combination of BKK (Bupivacaine HCl 60 mg [3 mg/mL], Ketorolac Tromethamine 24 mg [1.2mg/mL], Ketamine HCl 24 mg [1.2 mg/mL]) vs the control group receiving 20 cc of 0.5% bupivacaine (Bupivacaine HCL 100 mg [5mg/ml]. The dose can be repeated multiple times during the procedure as per operator's discretion. The patients will be further stratified into sub-groups based on type of procedure they had undergone. Analgesia/anesthesia strategy will be local infiltration of the drug along with a sedating agent based on institutional standard of care. The dose of the medicines will be adjusted as per discretion of the operator to maintain adequate anesthesia/analgesia during and after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Alone | Other | This is the control group of patients receiving 20 cc of 0.5% bupivacaine (Bupivacaine HCL 100 mg [5mg/ml] alone. The dose and number of doses of the medicines will be adjusted as per discretion of the operator. Receives: Drug: Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination |
| Bupivacaine-Ketorolac-Ketamine (BKK) Combination | Experimental | This is the intervention group of patients receiving 20 cc combination of BKK (Bupivacaine HCl 60 mg [3 mg/mL], Ketorolac Tromethamine 24 mg [1.2mg/mL], Ketamine HCl 24 mg [1.2 mg/mL]).The dose and number of doses of the medicines will be adjusted as per discretion of the operator. Receives: Drug: Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensity
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensity. Patient's pain will be assessed using a Visual Analog Scale either through a telephone call from the research team or via clinic follow-up visit. The visual analog scale (VAS) determines pain from 0 to 10 with 0 indicating no pain (Better outcome) and 10 indicating worse pain in their life indicating (worse outcome).
Measured: Upto 1 week
Comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfort
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfort. Patient's comfort will be assessed using a verbal rating score either through a telephone call from the research team or via clinic follow-up visit. The comfort score determines patients comfort from 0 to 100 with 0 indicating extremely uncomfortable (Worse outcome) and 100 indicating extremely comfortable (Better outcome).
Measured: Upto 1 week
Comparative efficacy/superiority of BKK compared to bupivacaine alone in Quality of Life (QoL)
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority of BKK compared to bupivacaine alone in Quality of Life. Patient's Quality of Life will be assessed using a QoL score (EQ5-5D-5L) either through a telephone call from the research team or via clinic follow-up visit. The Quality of life questionnaire (EQ-5D-5L) has five response levels : no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5), with low values suggesting better outcomes and higher values suggesting worse outcomes.
Measured: Upto 1 week
Secondary outcomes (4)
Hospital readmission rates
Hospital readmission rates due to device implantation related pain or surgical site infection will be analyzed.
Measured: Until 7 days (Until the end of the sutdy)
Adverse Effects
Rates of adverse effects, including allergic reaction, worsening of the renal function, presyncope/syncope, HTN, drug-drug interaction or any patient reported side effects will be analyzed.
Measured: Until 7 days (Until the end of the sutdy)
Cost comparison of medications
Cost of medications will be compared.
Measured: Upto 1 week
Amount of pain medication used
Amount of pain medication used will be analyzed
Measured: Upto 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study startJan 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, CA
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, Kansas City Heart Rhythm Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575999
- Sponsor's protocol ID
- KCHRRF-PAINFREE POCKET-0016
- Status last verified
- Oct 2024
- First submitted
- 16 Sep 2022
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mariano ER, Dickerson DM, Szokol JW, Harned M, Mueller JT, Philip BK, Baratta JL, Gulur P, Robles J, Schroeder KM, Wyatt KEK, Schwalb JM, Schwenk ES, Wardhan R, Kim TS, Higdon KK, Krishnan DG, Shilling AM, Schwartz G, Wiechmann L, Doan LV, Elkassabany NM, Yang SC, Muse IO, Eloy JD, Mehta V, Shah S, Johnson RL, Englesbe MJ, Kallen A, Mukkamala SB, Walton A, Buvanendran A. A multisociety organizational consensus process to define guiding principles for acute perioperative pain management. Reg Anesth Pain Med. 2022 Feb;47(2):118-127. doi: 10.1136/rapm-2021-103083. Epub 2021 Sep 22.
PubMed 34552003De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.
PubMed 21965355Wolfe RC, Spillars A. Local Anesthetic Systemic Toxicity: Reviewing Updates From the American Society of Regional Anesthesia and Pain Medicine Practice Advisory. J Perianesth Nurs. 2018 Dec;33(6):1000-1005. doi: 10.1016/j.jopan.2018.09.005. No abstract available.
PubMed 30449428Nair GM, Birnie DH, Sumner GL, Krahn AD, Healey JS, Nery PB, Kalfon E, Verma A, Ayala-Paredes F, Coutu B, Becker G, Philippon F, Eikelboom J, Sandhu RK, Sapp J, Leather R, Yung D, Thibault B, Simpson CS, Ahmad K, Sturmer M, Kavanagh K, Crystal E, Wells GA, Essebag V; BRUISE CONTROL Investigators. Post-operative pain following cardiac implantable electronic device implantation: insights from the BRUISE CONTROL trials. Europace. 2021 May 21;23(5):748-756. doi: 10.1093/europace/euaa349.
PubMed 33367623Neuman MD, Bateman BT, Wunsch H. Inappropriate opioid prescription after surgery. Lancet. 2019 Apr 13;393(10180):1547-1557. doi: 10.1016/S0140-6736(19)30428-3.
PubMed 30983590Clerc S, Vuilleumier H, Frascarolo P, Spahn DR, Gardaz JP. Is the effect of inguinal field block with 0.5% bupivacaine on postoperative pain after hernia repair enhanced by addition of ketorolac or S(+) ketamine? Clin J Pain. 2005 Jan-Feb;21(1):101-5. doi: 10.1097/00002508-200501000-00012.
PubMed 15599137
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management in Cardiac Implantable Electronic Device Insertion; Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain
- ClinicalTrials.gov ID
- NCT05575999
- Acronym / sponsor ID
- KCHRRF-PAINFREE POCKET-0016
- Conditions
- Pain Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Collaborators
- Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, CA
- Study start
- Jan 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Oct 2022 (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.
Bupivacaine is the most widely used local anesthetic agent across majority of the Cardiac Implantable Electronic device (CIED) implant procedures in the United States. It is hypothesized that the combination of Bupivacaine-Ketorolac-Ketamine (BKK) is more effective in alleviating perioperative and postoperative pain as compared to the use of bupivacaine alone.
A few studies have been done to look for the effectiveness of BKK in abdominal surgical procedures. However, no study has been done to evaluate its efficacy and effectiveness in patients undergoing CIED insertion.
Detailed description
Bupivacaine is a widely used local anesthetic and is often administered by spinal injection prior to major surgical procedures. Ketorolac is a potent NSAID which is used for the short-term relief of moderate to severe pain. It's used for long term duration is generally limited due to its potential to cause GI ulcers/perforation and renal failure. A single dose of perioperative Ketorolac has been found to be effective in reducing opioid consumption. Ketamine is NMDA receptor antagonist and is used for its anesthetic, analgesic, and psychotomimetic effects. It is primarily used for induction and maintenance of anesthesia and induces a trance like state providing pain relief, sedation, and amnesia.
Although an effective local anesthetic agent, bupivacaine has weak analgesic effect and is used in combination with several analgesic agents for effective perioperative and postoperative analgesia. A common drug used in this analgesic regimen usually includes opioids such as morphine, oxycodone, and fentanyl. Over the last few decades the United States has witnessed an opioid epidemic and post-surgical opioid prescription is one of the major contributors of this epidemic. An opioid free combination of Bupivacaine-Ketorolac-Ketamine (BKK) is thought to be effective in alleviating perioperative and postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Alone | Other | Drug: Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) CombinationThis is the control group of patients receiving 20 cc of 0.5% bupivacaine (Bupivacaine HCL 100 mg [5mg/ml] alone. The dose and number of doses of the medicines will be adjusted as per discretion of the operator. |
| Bupivacaine-Ketorolac-Ketamine (BKK) Combination | Experimental | Drug: Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) CombinationThis is the intervention group of patients receiving 20 cc combination of BKK (Bupivacaine HCl 60 mg [3 mg/mL], Ketorolac Tromethamine 24 mg [1.2mg/mL], Ketamine HCl 24 mg [1.2 mg/mL]).The dose and number of doses of the medicines will be adjusted as per discretion of the operator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both male and female patients
- Patients older than 18 years of age
- Patients undergoing new CIED (ICD, pacemaker, CRT-D or CRT-P)
- Patients willing to participate in the study
Key exclusion criteria (6 listed)
- Patients with prior history of allergic reaction to any component of the drug; bupivacaine, ketorolac, or ketamine
- Pregnant or breastfeeding patients
- Prisoners
- Patients younger than 18 years of age
- Patients not willing to participate in the study
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 |
|---|---|---|
| Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) CombinationThe plan will be to stratify patients in two groups: intervention group receiving 20 cc combination of BKK (Bupivacaine HCl 60 mg [3 mg/mL], Ketorolac Tromethamine 24 mg [1.2mg/mL], Ketamine HCl 24 mg [1.2 mg/mL]) vs the control group receiving 20 cc of 0.5% bupivacaine (Bupivacaine HCL 100 mg [5mg/ml]. The dose can be repeated multiple times during the procedure as per operator's discretion. The patients will be further stratified into sub-groups based on type of procedure they had undergone. Analgesia/anesthesia strategy will be local infiltration of the drug along with a sedating agent based on institutional standard of care. The dose of the medicines will be adjusted as per discretion of the operator to maintain adequate anesthesia/analgesia during and after the procedure. | Drug | Bupivacaine Alone, Bupivacaine-Ketorolac-Ketamine (BKK) Combination |
Primary outcome
Comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensity
Time frame: Upto 1 week
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensity. Patient's pain will be assessed using a Visual Analog Scale either through a telephone call from the research team or via clinic follow-up visit. The visual analog scale (VAS) determines pain from 0 to 10 with 0 indicating no pain (Better outcome) and 10 indicating worse pain in their life indicating (worse outcome).
Comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfort
Time frame: Upto 1 week
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfort. Patient's comfort will be assessed using a verbal rating score either through a telephone call from the research team or via clinic follow-up visit. The comfort score determines patients comfort from 0 to 100 with 0 indicating extremely uncomfortable (Worse outcome) and 100 indicating extremely comfortable (Better outcome).
Comparative efficacy/superiority of BKK compared to bupivacaine alone in Quality of Life (QoL)
Time frame: Upto 1 week
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority of BKK compared to bupivacaine alone in Quality of Life. Patient's Quality of Life will be assessed using a QoL score (EQ5-5D-5L) either through a telephone call from the research team or via clinic follow-up visit. The Quality of life questionnaire (EQ-5D-5L) has five response levels : no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5), with low values suggesting better outcomes and higher values suggesting worse outcomes.
4 secondary outcomes
Hospital readmission rates
Time frame: Until 7 days (Until the end of the sutdy)
Adverse Effects
Time frame: Until 7 days (Until the end of the sutdy)
Cost comparison of medications
Time frame: Upto 1 week
Amount of pain medication used
Time frame: Upto 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 34552003Mariano ER, Dickerson DM, Szokol JW, Harned M, Mueller JT, Philip BK, Baratta JL, Gulur P, Robles J, Schroeder KM, Wyatt KEK, Schwalb JM, Schwenk ES, Wardhan R, Kim TS, Higdon KK, Krishnan DG, Shilling AM, Schwartz G, Wiechmann L, Doan LV, Elkassabany NM, Yang SC, Muse IO, Eloy JD, Mehta V, Shah S, Johnson RL, Englesbe MJ, Kallen A, Mukkamala SB, Walton A, Buvanendran A. A multisociety organizational consensus process to define guiding principles for acute perioperative pain management. Reg Anesth Pain Med. 2022 Feb;47(2):118-127. doi: 10.1136/rapm-2021-103083. Epub 2021 Sep 22.
- Background: PubMed 21965355De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.
- Background: PubMed 30449428Wolfe RC, Spillars A. Local Anesthetic Systemic Toxicity: Reviewing Updates From the American Society of Regional Anesthesia and Pain Medicine Practice Advisory. J Perianesth Nurs. 2018 Dec;33(6):1000-1005. doi: 10.1016/j.jopan.2018.09.005. No abstract available.
- Background: PubMed 33367623Nair GM, Birnie DH, Sumner GL, Krahn AD, Healey JS, Nery PB, Kalfon E, Verma A, Ayala-Paredes F, Coutu B, Becker G, Philippon F, Eikelboom J, Sandhu RK, Sapp J, Leather R, Yung D, Thibault B, Simpson CS, Ahmad K, Sturmer M, Kavanagh K, Crystal E, Wells GA, Essebag V; BRUISE CONTROL Investigators. Post-operative pain following cardiac implantable electronic device implantation: insights from the BRUISE CONTROL trials. Europace. 2021 May 21;23(5):748-756. doi: 10.1093/europace/euaa349.
- Background: PubMed 30983590Neuman MD, Bateman BT, Wunsch H. Inappropriate opioid prescription after surgery. Lancet. 2019 Apr 13;393(10180):1547-1557. doi: 10.1016/S0140-6736(19)30428-3.
- Background: PubMed 15599137Clerc S, Vuilleumier H, Frascarolo P, Spahn DR, Gardaz JP. Is the effect of inguinal field block with 0.5% bupivacaine on postoperative pain after hernia repair enhanced by addition of ketorolac or S(+) ketamine? Clin J Pain. 2005 Jan-Feb;21(1):101-5. doi: 10.1097/00002508-200501000-00012.
- 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.
Dhanunjaya Lakkireddy, MD principal investigator
Kansas City Heart Rhythm Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination in people with Pain Management, run by Kansas City Heart Rhythm Research Foundation at 3 sites 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donita Atkins (816-651-1969, datkins@kchrf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensity (time frame: Upto 1 week). 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?
On the ClinicalTrials.gov record for NCT05575999, which also lists 6 linked publications.
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 28 Aug 2025.