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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Kansas City Heart Rhythm Research Foundation
Study ID
NCT05575999
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Pain Management

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination — DRUG
    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 Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Oct 2024
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Bupivacaine Alone
    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.
  • Experimental: Bupivacaine-Ketorolac-Ketamine (BKK) Combination
    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.

Primary Outcome Measure

Comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensity [ Time Frame: Upto 1 week ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Loma Linda University HealthLoma LindaCalifornia92350-
Kansas City Heart Rhythm InstituteOverland ParkKansas66211-
Overland Park Regional Medical CenterOverland ParkKansas66215-

Find similar trials in Loma Linda, CA

By research site
Loma Linda University Health· Loma Linda, CAKansas City Heart Rhythm Institute· Overland Park, KSOverland Park Regional Medical Center· Overland Park, KS

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