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Erector Spinae Plane Block: For Pain Control in Patients Undergoing Flank Incision

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691935
Recruitment Status : Enrolling by invitation
First Posted : October 2, 2018
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Alireza Aminsharifi, Milton S. Hershey Medical Center

Study Description
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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 incision as compared to the standard of care of using IV and oral opiates.

Condition or disease Intervention/treatment Phase
Nephrectomy Partial Nephrectomy Incision Site Discomfort Drug: Ropivacaine Drug: Normal saline Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Erector Spinae Plane Block (ESPB): A New Technique for Perioperative Pain Control in Patients Undergoing Surgery Through a Flank Incision.
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : February 28, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Sham anesthetic


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691935


Locations
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United States, Pennsylvania
Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Alireza Aminsharifi, M.D. Milton S. Hershey Medical Center
Principal Investigator: Sanjib Adhikary, M.D. Milton S. Hershey Medical Center
More Information
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Publications:

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Responsible Party: Alireza Aminsharifi, Assistant Professor of Surgery, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03691935    
Other Study ID Numbers: STUDY00008663
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Alireza Aminsharifi, Milton S. Hershey Medical Center:
kidney
surgery
analgesia
surgical incision
 opioid sparing
flank pain
local anesthesia
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries
Ropivacaine
Anesthetics
Anesthetics, Local
 Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents