Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03476642
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 46
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The primary objectives of this study are to define the extent of dermatomal anesthesia and anatomical spread of injectate (as defined by MRI imaging) that is provided by an ESP block at the T5 level, using twenty milliliters of 0.5% ropivacaine.

The secondary objectives include: 1) the measurement of changes in hemodynamic parameters associated with the ESP block, 2) the duration of sensory effects provided by ropivacaine with or without epinephrine, 3) the venous plasma concentration of ropivacaine associated at various time intervals after completion of the ESP block.

Condition or Disease	Intervention/Treatment	Phase
Distribution of Ropivacaine in Erector Spinae Plane Block	Drug: Ropivacaine; Drug: Epinephrine	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This will be a randomized,double blinded, controlled study.This will be a randomized,double blinded, controlled study.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: A Volunteer Study to Determine the Anatomical Distribution of Injectate, the Extent of Sensory Block, and the Pharmacokinetics of Ropivacaine Following Erector Spinae Plane (ESP) Blocks.
• Actual Study Start Date: Jul 2, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ropivacaine with Epinephrine Group RE will have 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.	Drug: Ropivacaine; injection of 20mL of 0.5% Ropivacaine at the left or right T5 transverse process; Drug: Epinephrine; injection of 20mL epinephrine in combination with ropivacaine at the left or right T5 transverse process
Active Comparator: Ropivacaine without Epinephrine Group R will have 20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.	Drug: Ropivacaine; injection of 20mL of 0.5% Ropivacaine at the left or right T5 transverse process

Outcome Measures

Primary Outcome Measures

1. Extent of dermatomal sensory loss [0 to 360 minutes from the time of the ESP block]

   A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin

2. Duration of sensory loss [0 to 360 minutes from the time of the ESP block]

   A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin

3. Anatomical extent of injectate spread using MRI [30 and 90 minutes from the time of the ESP block]

   The subject will undergo two MRIs to determine the spread of the anesthetic.

4. Venous plasma concentration of ropivacaine at periodic time intervals [These samples will be repeated at 20, 40, 60, 90, 120, and 240 minutes after completion of the injection of active drug.]

   3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.

Secondary Outcome Measures

1. Blood pressure at periodic time intervals [Up to 360 minutes from the time of the ESP block]

   Non- invasive monitoring of blood pressure every 5 minutes.

2. Any adverse effects or side effects related to injection of the medications [0-3 days after the block is complete]

3. ECG at periodic time intervals [Up to 360 minutes from the time of the ESP block]

   Recording ECG every 5 minutes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy adults aged 18 to 60 inclusive

• Weight between 60 and 100 kg inclusive

• Height 160 to190 cm inclusive

Exclusion Criteria:

• Pregnant females

• Chronic medical condition requiring medication

• History of previous major spinal, abdominal or thoracic surgery

• Congenital abnormalities of the spine, back, thorax or abdomen

• History of major trauma to the thorax or abdomen;

• Allergy to ropivacaine or other amide local anesthetics

• The presence of any metallic implant in their body

• Any contraindication to magnetic resonance imaging as determined by completion of a standard questionnaire administered to all patients undergoing magnetic resonance imaging.

• Allergy to Gadolinium radiological contrast agent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Milton S.Hershey Medical center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center

Investigators

• Principal Investigator: Sanjib Adhikary, MD, Milton S. Hershey Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanjib D Adhikary, Associate Professor, Director Acute Pain, Regional Anesthesia/Ortho, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT03476642
• Other Study ID Numbers: STUDY0008641
• First Posted: Mar 26, 2018
• Last Update Posted: Jan 11, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Epinephrine; Ropivacaine

Study Results

No Results Posted as of Jan 11, 2022