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Clinical Trials/NCT03691935
NCT03691935
Terminated
Phase 4

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

Milton S. Hershey Medical Center1 site in 1 country20 target enrollmentSeptember 28, 2018

Overview

Phase
Phase 4
Intervention
Ropivacaine
Conditions
Nephrectomy
Sponsor
Milton S. Hershey Medical Center
Enrollment
20
Locations
1
Primary Endpoint
Pain Scores Using the Visual Analogue Pain Scale From Zero Pain to Level Ten Pain
Status
Terminated
Last Updated
last year

Overview

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)

Registry
clinicaltrials.gov
Start Date
September 28, 2018
End Date
February 2, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alireza Aminsharifi

Assistant Professor of Surgery

Milton S. Hershey Medical Center

Eligibility Criteria

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

Arms & Interventions

Ropivicaine

Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.

Intervention: Ropivacaine

Normal Saline

Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.

Intervention: Normal saline

Outcomes

Primary Outcomes

Pain Scores Using the Visual Analogue Pain Scale From Zero Pain to Level Ten Pain

Time Frame: 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

Study Sites (1)

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