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

Phase 4

Terminated

• Conditions: Nephrectomy; Partial Nephrectomy; Incision Site Discomfort
• Interventions: Drug: Ropivacaine; Drug: Normal saline

• Registration Number: NCT03691935
• Lead Sponsor: Milton S. Hershey Medical Center

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)

Study Timeline

• Study First Submitted: 2018-03-28
• Study Start: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-02
• Primary Completion: 2024-01-19
• Study Completion: 2024-02-02
• Status Verified: 2025-01
• Results First Submitted: 2025-01-17
• Results First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Results First Posted: 2025-02-10
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivicaine	Ropivacaine	Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
Normal Saline	Normal saline	Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.

Primary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Milton S Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States