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Erector Spinae Plane Block for Carotid Endarterectomy

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: NCT04224844
Recruitment Status : Suspended (not recruiting, awaiting for changes in IRB)
First Posted : January 13, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Antalya Training and Research Hospital

Brief Summary:
The purpose of this study is to test the hypothesis that erector spinae plane block will decrease intraoperative local anesthetic and postoperative analgesic consumption in patients undergoing carotid endarterectomy.

Condition or disease Intervention/treatment Phase
Pain Other: Erector spinae plane block Other: Control group Not Applicable

Detailed Description:
Patients who decided to participate in the study will be randomized into 2 groups: Erector Spinae Plane Block Group (Group E) and Control Group (Group C). Intraoperative local anesthetic consumption, postoperative tramadol consumption, intraoperative and pain scores, hemodynamic parameters and patient satisfaction will be recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Ultrasound-Guided Spinae Plane Block for Perioperative Pain Control in Carotid Endarterectomy.
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Active Comparator: Erector spinae plane block group (Group 1)
Patients will receive erector spinae plane block in addition to intravenous patient-controlled analgesia device containing tramadol.
Other: Erector spinae plane block
The block will be performed before the surgery. The spinous process of T2 or T3 wil be identified by an ultrasound guide, with the probe positioned longitudinally. A block needle will be inserted in the caudo-cephal direction. After the injection site is confirmed by 3 ml of physiological solution and correct position of the needle tip is confirmed, bupivacaine will be injected. The patients assigned to this group will also receive an intravenous patient-controlled analgesia device containing tramadol postoperatively.

Active Comparator: Control group (Group 2)
Control group will receive only intravenous patient-controlled analgesia device containing tramadol.
Other: Control group
Control group will receive only patient-controlled analgesia device containing tramadol. No block will be performed.




Primary Outcome Measures :
  1. 24 hours tramadol consumption [ Time Frame: 24 hours ]
    Total tramadol consumption in milligrams at 24 hrs will be scored.

  2. 6 hours tramadol consumption [ Time Frame: 6 hours ]
    Total tramadol consumption in milligrams at 6 hrs will be scored.

  3. 12 hours tramadol consumption [ Time Frame: 12 hours ]
    Total tramadol consumption in milligrams at 12 hrs will be scored.

  4. Assesment of postoperative analgesia [ Time Frame: 24 hours ]
    Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 24 hrs.

  5. Assesment of postoperative analgesia [ Time Frame: 6 hours ]
    Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 6 hours.

  6. Assesment of postoperative analgesia [ Time Frame: 12 hours ]
    Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 12 hours.


Secondary Outcome Measures :
  1. Amount of use of intraoperative local anesthetic. [ Time Frame: 1 hour ]
    Intraoperative pain will be assessed using a visual analog scale (VAS) (from 0 = no pain to 10 = maximum possible pain). When intraoperative VAS is >3, supplemental local anesthetic will be administered to the surgical area by the surgeon. Amount of total local anesthetic in milligrams will be recorded at the end of the surgery.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing carotid endarterectomy
  • American Society of Anesthesiologists class 2 to 3
  • Ability to consent

Exclusion Criteria:

  • inability to communicate
  • not understand the aim and objectives of the study
  • not provide informed written consent
  • contraindications for the block (local infection, coagulation disorders)
  • hypersensitivity to the local anesthetics
  • refusal of regional anesthesia

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): NCT04224844


Locations
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Turkey
Antalya Training and Reseach Hospital
Antalya, Turkey
Sponsors and Collaborators
Antalya Training and Research Hospital
Investigators
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Principal Investigator: Ali Sait Kavakli, M.D. Antalya Training and Research Hospital
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Responsible Party: Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04224844    
Other Study ID Numbers: AntalyaTRH029
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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