A Phase 4 interventional study of Ropivacaine and Normal saline in Nephrectomy, Partial Nephrectomy and Incision Site Discomfort, sponsored by Milton S. Hershey Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Milton S. Hershey Medical Center · Phase 4, Interventional, and Treatment
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.
40 subjects will be randomized in to 2 groups, with 20 in each group.
519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 412 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
Drug: Ropivacaine
Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.
Drug: Normal saline
Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
Also known as: Naropin
Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control
Also known as: Sham anesthetic
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
| Milestone | Ropivicaine | Normal Saline |
|---|---|---|
| Started | 11 | 9 |
| Completed | 6 | 8 |
| Not completed | 5 | 1 |
| Withdrew: Physician decision | 2 | 1 |
| Withdrew: Adverse event | 3 | 0 |
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
| units on a scale | Ropivicaine | Normal Saline |
|---|---|---|
| Pain Scores Using the Visual Analogue Pain Scale From Zero Pain to Level Ten Pain | 3.55 ± 1.2 | 4.6 ± 2.15 |
Collected over From enrollment to 14 days post-op for each subject. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ropivicaine | 0/11 (0%) | 1/11 (9.1%) | 3/11 (27.3%) |
| Normal Saline | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| Event | Ropivicaine | Normal Saline |
|---|---|---|
| Post-op ileusGastrointestinal disorders | 1/11 | 0/9 |
| Event | Ropivicaine | Normal Saline |
|---|---|---|
| Increased painGeneral disorders | 3/11 | 1/9 |
| Age, Continuous(years) | Ropivicaine | Normal Saline | Total |
|---|---|---|---|
| Mean | 57 ± 13 | 61 ± 9.2 | 59 ± 11 |
| Sex: Female, Male(Participants) | Ropivicaine | Normal Saline | Total |
|---|---|---|---|
| Female | 3 | 5 | 8 |
| Male | 8 | 4 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Ropivicaine | Normal Saline | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 10 | 9 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ropivicaine | Normal Saline | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 11 | 8 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Ropivicaine | Normal Saline | Total |
|---|---|---|---|
| United States | 11 | 9 | 20 |
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Milton S. Hershey Medical Center