Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain

Kansas City Heart Rhythm Research Foundation

Status and phase: Not yet enrolling; Phase 1

Conditions: Pain Management

Treatments: Drug: Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination

Study type: Interventional

Funder types: Other

Identifiers

NCT05575999

KCHRRF-PAINFREE POCKET-0016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Bupivacaine Alone

Other group

Description:

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.

Treatment:

Drug: Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination

Bupivacaine-Ketorolac-Ketamine (BKK) Combination

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination