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

November 7, 2023 updated by: Alireza Aminsharifi, Milton S. Hershey Medical Center

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Post Operative Day One, date of discharge and clinic follow up visit 14 days postoperatively.
Written questionnaire measuring impact of pain upon patient
Post Operative Day One, date of discharge and clinic follow up visit 14 days postoperatively.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of opiates
Time Frame: Through 14 days postoperatively.
Total IV and oral opiate during the hospitalization on Post Operative Days 1, 2 and 3 will be collected. Amount of oral opiates used from discharge to post operative visit
Through 14 days postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Alireza Aminsharifi, M.D., Milton S. Hershey Medical Center
  • Principal Investigator: Sanjib Adhikary, M.D., Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2018

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 2, 2018

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008663

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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