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

Penn State Health

Status and phase: Terminated; Phase 4

Conditions: Partial Nephrectomy; Nephrectomy; Incision Site Discomfort

Treatments: Drug: Normal saline; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03691935

STUDY00008663

Details and patient eligibility

About

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.

Full 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)

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Ropivicaine

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine

Normal Saline

Sham Comparator group

Description:

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

Treatment:

Drug: Normal saline