Clinical trial NCT05575999: Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain
Official title: Pain Management in Cardiac Implantable Electronic Device Insertion; Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pain Management
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
Collaborators: name: Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, CA
First posted: 2022-10-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensity
timeFrame: Upto 1 week
measure: Comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfort
timeFrame: Upto 1 week
measure: Comparative efficacy/superiority of BKK compared to bupivacaine alone in Quality of Life (QoL)
timeFrame: Upto 1 week
Secondary outcomes:
measure: Hospital readmission rates
timeFrame: Until 7 days (Until the end of the sutdy)
measure: Adverse Effects
timeFrame: Until 7 days (Until the end of the sutdy)
measure: Cost comparison of medications
timeFrame: Upto 1 week
measure: Amount of pain medication used
timeFrame: Upto 1 week
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nair 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.
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