Incision Site Discomfort, Nephrectomy, Partial Nephrectomy
Conditions
Keywords
kidney, surgery, analgesia, surgical incision, opioid sparing, flank pain, local anesthesia
Brief summary
Using a randomized double-blinded study design, the study goal is to evaluate the superiority of Erector Spinae Plane block (ESPB) in the peri-operative pain management of patients undergoing surgery through a flank or anterior subcostal incision as compared to the standard of care of using IV and oral opiates.
Detailed description
40 subjects will be randomized in to 2 groups, with 20 in each group. * Group 1. Erector spinae plane block (ESPB) (containing Ropivacaine) * Group 2. Sham Erector spinae plane block. (SESPB) (with normal saline)
Interventions
DRUGRopivacaine
Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
DRUGNormal saline
Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Consenting adults age 18-85 * American Society of Anesthesiologists (ASA) Physical Status classification I to III * Planned to be hospitalized for at least 24 hours post-op * Cognitive capacity to use the visual analogic scale (VAS) and complete the patient satisfaction survey
Exclusion criteria
* Patient refusal * Patients with allergies to local anesthetics or opiates (hydromorphone or oxycodone) * Scoliosis * Patients with chronic pain syndromes or who are on chronic pain medications/other neurologic medication of more than 3 months or whom have neuromodulators/stimulators * Concurrent surgeries requiring additional incisions on the body
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores Using the Visual Analogue Pain Scale From Zero Pain to Level Ten Pain | Aggregate pain scores for average length of hospital stay which is 3 days | Data will be collected via the electronic medical record and begin following patient randomization. The Visual Analogue Scale pain scales will be administered and collected on Post Operative Days 1, 2 and 3. Minimum value = 0 No Pain, Maximum value = 10 Worst possible, unbearable, excruciating pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ropivicaine Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
Ropivacaine: Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control | 11 |
| Normal Saline Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.
Normal saline: Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control | 9 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Physician Decision | 2 | 1 |
Baseline characteristics
| Characteristic | Ropivicaine | Total | Normal Saline |
|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 13 | 59 years STANDARD_DEVIATION 11 | 61 years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 19 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 19 Participants | 8 Participants |
| Region of Enrollment United States | 11 Participants | 20 Participants | 9 Participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 9 |
| other Total, other adverse events | 3 / 11 | 1 / 9 |
| serious Total, serious adverse events | 1 / 11 | 0 / 9 |
Outcome results
Primary
Pain Scores Using the Visual Analogue Pain Scale From Zero Pain to Level Ten Pain
Data will be collected via the electronic medical record and begin following patient randomization. The Visual Analogue Scale pain scales will be administered and collected on Post Operative Days 1, 2 and 3. Minimum value = 0 No Pain, Maximum value = 10 Worst possible, unbearable, excruciating pain
Time frame: Aggregate pain scores for average length of hospital stay which is 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivicaine | Pain Scores Using the Visual Analogue Pain Scale From Zero Pain to Level Ten Pain | 3.55 units on a scale | Standard Deviation 1.2 |
| Normal Saline | Pain Scores Using the Visual Analogue Pain Scale From Zero Pain to Level Ten Pain | 4.6 units on a scale | Standard Deviation 2.15 |