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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

January 31, 2026

Primary Completion Date

October 31, 2026

Study Completion Date

December 31, 2026

Conditions
Pain Management
Interventions
DRUG

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

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.

Trial Locations (3)

66211

Kansas City Heart Rhythm Institute, Overland Park

66215

Overland Park Regional Medical Center, Overland Park

92350

Loma Linda University Health, Loma Linda

All Listed Sponsors
collaborator

Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, CA

UNKNOWN

lead

Kansas City Heart Rhythm Research Foundation

OTHER