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the Effect of Retrolaminar Block on Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
retrolaminar block tecnique
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Postoperative Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kırıkkale Univercity Faculty of Medicine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

the group which retrolaminar block will be approved

the group which retrolaminar block will not be approved

Arm Description

the retrolaminar block will be made for postoperative analgesia

the retrolaminar block will not be made for postoperative analgesia

Outcomes

Primary Outcome Measures

change of pain throughout 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

Secondary Outcome Measures

Full Information

First Posted
December 19, 2019
Last Updated
March 29, 2022
Sponsor
Kırıkkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04209907
Brief Title
the Effect of Retrolaminar Block on Postoperative Pain
Official Title
the Effect of Retrolaminar Block on Post Operative Analgesia After Lumbar Vertebra Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the group which retrolaminar block will be approved
Arm Type
Active Comparator
Arm Description
the retrolaminar block will be made for postoperative analgesia
Arm Title
the group which retrolaminar block will not be approved
Arm Type
No Intervention
Arm Description
the retrolaminar block will not be made for postoperative analgesia
Intervention Type
Other
Intervention Name(s)
retrolaminar block tecnique
Intervention Description
By using ultrasound probe, the needle with in-plane , after seeing vertebral lamina, the local anesthetic will injectate
Primary Outcome Measure Information:
Title
change of pain throughout postoperative 24 hours
Description
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
Time Frame
change in postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-75 years old ASA 1, 2, 3 patients undergoing lumvar vertyebra surgery Exclusion Criteria: pregnant woman child patint wiht cognitive disfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevser Peker
Organizational Affiliation
Kırıkkale University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kırıkkale Univercity Faculty of Medicine Hospital
City
Kırıkkale
ZIP/Postal Code
71450
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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the Effect of Retrolaminar Block on Postoperative Pain

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