Kidney Stone, Surgery
Conditions
Brief summary
The purpose of this study is to determine if adding a spinal block (medicine that will numb parts of the body to block pain) along with standard pain control at the incision site will decrease the need for narcotics for pain management and decrease the percentage of patients requiring hospital admission for pain control during postoperative , in-hospital, care after a percutaneous nephrolithotomy (PCNL) (surgery to remove kidney stones), commonly called PERC.
Interventions
DRUG4mg PF Dexamethasone
analgesic provided in the erector spinae block is 20mL of 0.5% Bupivicaine with 4mg of PF Dexamethasone
DRUGControl Test
Peritubal block - standard local analgesic administration
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Anesthesia will know the randomization assignment. The surgeon and the patient will be blinded to randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥ 18 years Undergoing unilateral or bilateral PCNL for treatment of kidney stones Estimated glomerular filtration rate \> 30 mL/min. PCNL is planned as an outpatient procedure with no overnight hospital stay
Exclusion criteria
Inability to provide informed consent Pregnancy Patients having any additional simultaneous procedures other than a contralateral PCNL,(including contralateral treatment of kidney stones with a non-PCNL operation such as ureteroscopy) Patients with a documented neurologic injury that reduces pain sensation to the back Patients with an existing pain disorder Patients with an existing narcotics agreement due to current or prior narcotic abuse Patients with a documented allergy to a narcotic or NSAID analgesic BMI \> 35 Patients who require more than 1 site of percutaneous access into the kidney to adequately complete the PCNL (this is a judgment made preoperatively at the initial clinic patient encounter)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overnight Admission Rate | 24 hours | Percentage of patients in Groups 1 and 2 who require overnight admission to the hospital for pain control postoperatively (i.e. patients unable to be discharged to home from the postoperative anesthesia care unit PACU). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with Emergency Department return or re-admission | 14 days | Proportion of patient successfully discharged from PACU without return to Emergency Department or requiring re-admission within 14 days post discharge. |
| Number of Narcotic administrations post-operatively | 14 days | Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive |
| Number of Morphine Equivalents post-operatively | 14 days | Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive in daily morphine equivalents |
| Narcotic for Analgesia post-operatively | 14 days post-op | Comparison of the percentage of patients in Groups 1 and 2 who require any narcotic for analgesia during the postoperative course following PCNL. |
| Pain Score | 24 hours | Maximum patient reported pain score within the first 24 hours post operatively using 0-10 numeric pain intensity scale (NPIS) where 0 is no pain, 5 is moderate pain and 10 is the worst possible pain. |
| Rate of Adjunct Analgesics Post-operatively | 14 days | Nonsteroidal Anti-inflammatories * Y/N * If Yes, name & dose * If Yes, total # of times administered * If Yes total # of times administered/(LOS in hours/24) Gabbapentinoids * Y/N * If Yes, name & dose * If Yes, total # of times administered * If Yes total # of times administered/(LOS in hours/24) Acetaminophen * Y/N * If Yes, name & dose * If Yes, total # of times administered * If Yes total # of times administered/(LOS in hours/24) |
| Number of complications peri and post-operatively | 24 hours | Any complications (according to Clavien-Dindo classification11) during the surgery and postoperative hospital stay |
Countries
United States
Outcome results
None listed