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the Effect of Retrolaminar Block on Postoperative Pain

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04209907
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : June 11, 2020
Information provided by (Responsible Party):
Kevser Peker, Kırıkkale University

Brief Summary:
In recent years, as a part of multimodal analgesia, paravertebral blocks are replacing epidural analgesia due to the less side effects. Although the risk of pneumothorax is the most feared complication in paravertebral blocks, retrolaminar block (RLB) -which is a paravertebral block- significantly reduces this risk due to the anatomical technique of procedure. The investigators aim to investigate the effect of retrolaminar block with ultrasound- guided on perioperative analgesia for patients undergoing lumbar vertebra surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Other: retrolaminar block tecnique Not Applicable

Detailed Description:

Retrolaminar block will applie before general anesthesia induction when patients will be awake and under midazolam (0.03 mg/kg) sedation and standardized monitoring at the preoperative block area in sitting position using in-plane approach. After sterilising the skin, the investigators will perform block by using 7-18 MHz convex ultrasound probe ( Esaote My Lab 6 US Machine, Florance, Italy) and a 22-gauge, 100-mm Stimuplex needle (B. Braun, Germany). The investigators will pass in a sagittal plane from medial to lateral at the mid-lomber level, and identified the hyperechoic laminae, transverse processes, ribs and pleura.

The L3 laminae will be identified approximately lateral of the spinous process. The needle will insert in-plane, cephalad to caudad. After lamina contact and negative aspiration, 20 ml bupivacaine 0.25% will be injected at low pressure with intermittent negative aspiration on each side and spread of local anesthetic between laminae and paraspinous muscles will be seen without pain or paresthesia. Then 30 minutes later, the patient will be taken to the operating room.

After general anesthesia prosedure, the patients will evaluate whether they have pain throughout 24 hours after the operation. The pain scores will be evaluated with visuel analogue scale.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: the Effect of Retrolaminar Block on Post Operative Analgesia After Lumbar Vertebra Surgery
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Arm Intervention/treatment
Active Comparator: the group which retrolaminar block will be approved
the retrolaminar block will be made for postoperative analgesia
Other: retrolaminar block tecnique
By using ultrasound probe, the needle with in-plane , after seeing vertebral lamina, the local anesthetic will injectate

No Intervention: the group which retrolaminar block will not be approved
the retrolaminar block will not be made for postoperative analgesia

Primary Outcome Measures :
  1. change of pain throughout postoperative 24 hours [ Time Frame: change in postoperative 24 hours ]
    visuel analogue scale is used for post operative pain evaluation. it is range from 0 to 10. 0 is used for no pain, 10 is used severe pain. the investigors will evaluate the postoperative pain with visuel analogue scale

Information from the National Library of Medicine

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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

Inclusion Criteria:

  1. 18-75 years old
  2. ASA 1, 2, 3 patients
  3. undergoing lumvar vertyebra surgery

Exclusion Criteria:

  1. pregnant woman
  2. child
  3. patint wiht cognitive disfunction

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 identifier (NCT number): NCT04209907

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Contact: Kevser Peker 05071944182

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Kırıkkale Univercity Faculty of Medicine Hospital Recruiting
Kırıkkale, Turkey, 71450
Contact: Kevser Peker    +903183335000 ext 5282   
Sponsors and Collaborators
Kırıkkale University
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Principal Investigator: Kevser Peker Kırıkkale University Faculty of Medicine
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Responsible Party: Kevser Peker, assitant professor, Kırıkkale University Identifier: NCT04209907    
Other Study ID Numbers: retolaminar block
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms