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

Primary Purpose

Nephrectomy, Partial Nephrectomy, Incision Site Discomfort

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Normal saline
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrectomy focused on measuring kidney, surgery, analgesia, surgical incision, opioid sparing, flank pain, local anesthesia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Milton S Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ropivicaine

Normal Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain scores using the Visual Analogue Pain Scale from zero pain to level ten pain
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

Patient Satisfaction Survey of Pain Control Over Time
Written questionnaire measuring impact of pain upon patient

Full Information

First Posted
March 28, 2018
Last Updated
October 10, 2022
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03691935
Brief Title
Erector Spinae Plane Block: For Pain Control in Patients Undergoing Flank Incision
Official Title
Erector Spinae Plane Block (ESPB): A New Technique for Perioperative Pain Control in Patients Undergoing Surgery Through a Flank Incision.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrectomy, Partial Nephrectomy, Incision Site Discomfort
Keywords
kidney, surgery, analgesia, surgical incision, opioid sparing, flank pain, local anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropivicaine
Arm Type
Experimental
Arm Description
Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
Arm Title
Normal Saline
Arm Type
Sham Comparator
Arm Description
Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Sham anesthetic
Intervention Description
Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control
Primary Outcome Measure Information:
Title
Pain scores using the Visual Analogue Pain Scale from zero pain to level ten pain
Description
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.
Time Frame
Aggregate pain scores for average length of hospital stay which is 3 days
Secondary Outcome Measure Information:
Title
Patient Satisfaction Survey of Pain Control Over Time
Description
Written questionnaire measuring impact of pain upon patient
Time Frame
Post Operative Day One, date of discharge and clinic follow up visit 14 days postoperatively.
Other Pre-specified Outcome Measures:
Title
Total amount of opiates
Description
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
Time Frame
Through 14 days postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Aminsharifi, M.D.
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanjib Adhikary, M.D.
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23233109
Citation
Sharma V, Margreiter M. Partial nephrectomy: is there still a need for open surgery? Curr Urol Rep. 2013 Feb;14(1):1-4. doi: 10.1007/s11934-012-0297-2.
Results Reference
background
PubMed Identifier
23392233
Citation
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
Results Reference
background
PubMed Identifier
24356102
Citation
Gerbershagen HJ, Pogatzki-Zahn E, Aduckathil S, Peelen LM, Kappen TH, van Wijck AJ, Kalkman CJ, Meissner W. Procedure-specific risk factor analysis for the development of severe postoperative pain. Anesthesiology. 2014 May;120(5):1237-45. doi: 10.1097/ALN.0000000000000108.
Results Reference
background
PubMed Identifier
16149361
Citation
de Beer Jde V, Winemaker MJ, Donnelly GA, Miceli PC, Reiz JL, Harsanyi Z, Payne LW, Darke AC. Efficacy and safety of controlled-release oxycodone and standard therapies for postoperative pain after knee or hip replacement. Can J Surg. 2005 Aug;48(4):277-83.
Results Reference
background
PubMed Identifier
16359206
Citation
Recart A, Duchene D, White PF, Thomas T, Johnson DB, Cadeddu JA. Efficacy and safety of fast-track recovery strategy for patients undergoing laparoscopic nephrectomy. J Endourol. 2005 Dec;19(10):1165-9. doi: 10.1089/end.2005.19.1165.
Results Reference
background
PubMed Identifier
12651647
Citation
Watcha MF, Issioui T, Klein KW, White PF. Costs and effectiveness of rofecoxib, celecoxib, and acetaminophen for preventing pain after ambulatory otolaryngologic surgery. Anesth Analg. 2003 Apr;96(4):987-994. doi: 10.1213/01.ANE.0000053255.93270.31.
Results Reference
background
PubMed Identifier
28235492
Citation
Yenidunya O, Bircan HY, Altun D, Caymaz I, Demirag A, Turkoz A. Anesthesia management with ultrasound-guided thoracic paravertebral block for donor nephrectomy: A prospective randomized study. J Clin Anesth. 2017 Feb;37:1-6. doi: 10.1016/j.jclinane.2016.10.038. Epub 2016 Dec 15.
Results Reference
background
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
background
PubMed Identifier
28252539
Citation
Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.
Results Reference
background
PubMed Identifier
28188621
Citation
Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
Results Reference
background
PubMed Identifier
20400379
Citation
Gordon DB, Polomano RC, Pellino TA, Turk DC, McCracken LM, Sherwood G, Paice JA, Wallace MS, Strassels SA, Farrar JT. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010 Nov;11(11):1172-86. doi: 10.1016/j.jpain.2010.02.012. Epub 2010 Apr 18.
Results Reference
background

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

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