Erector Spinae Plane Block (ESPB): in Patients Undergoing Surgery Through a Flank or Anterior Subcostal Incision.

Study Overview
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Brief Summary
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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
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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)

Official Title
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Erector Spinae Plane Block (ESPB): A New Technique for Perioperative Pain Control in Patients Undergoing Surgery Through a Flank or Anterior Subcostal Incision.

Conditions
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Nephrectomy, Partial Nephrectomy, Incision Site Discomfort

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivicaine<br>Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs. | Drug: Ropivacaine<br>* Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control<br>* Other names: Naropin;|
| Sham Comparator: Normal Saline<br>Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs. | Drug: Normal saline<br>* Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control<br>* Other names: Sham anesthetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Aggregate pain scores for average length of hospital stay which is 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Survey of Pain Control Over Time | Written questionnaire measuring impact of pain upon patient | Post Operative Day One, date of discharge and clinic follow up visit 14 days postoperatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney, surgery, analgesia, surgical incision, opioid sparing, flank pain, local anesthesia