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Clinical trial

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

ID
Name
STUDY00008663
Description
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.
Trial arms
Trial start
2018-09-28
Estimated PCD
2025-02-28
Trial end
2025-02-28
Phase
Early phase I
Treatment
Ropivacaine
Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
Arms:
Ropivicaine
Other names:
Naropin
Normal saline
Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control
Arms:
Normal Saline
Other names:
Sham anesthetic
Size
40
Primary endpoint
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
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-11-09

1 organization

2 products

3 indications

Organization
Milton S. Hershey Medical Center
Product
Ropivacaine
Indication
Kidney Removal
Indication
Partial Nephrectomy
Indication
Incision Site Discomfort
Product
Normal saline