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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Suzanne Merrill，Milton S. Hershey Medical Center

Tracking Information

First Submitted Date ^ICMJE

March 28, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

February 28, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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)

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Ropivacaine
Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
Drug: Normal saline
Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

February 28, 2020

Estimated Primary Completion Date

February 28, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Suzanne Merrill，Milton S. Hershey Medical Center

Study Sponsor ^ICMJE

Milton S. Hershey Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Suzanne B Merrill, M.D. Milton S. Hershey Medical Center
Principal Investigator: Sanjib Adhikary, M.D. Milton S. Hershey Medical Center

PRS Account

Milton S. Hershey Medical Center

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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