the Effect of Retrolaminar Block on Postoperative Pain
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable postoperative-pain
Started May 2020
Typical duration for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2019
CompletedFirst Posted
Study publicly available on registry
December 24, 2019
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedApril 7, 2022
March 1, 2022
1.1 years
December 19, 2019
March 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
change in postoperative 24 hours
Study Arms (2)
the group which retrolaminar block will be approved
ACTIVE COMPARATORthe retrolaminar block will be made for postoperative analgesia
the group which retrolaminar block will not be approved
NO INTERVENTIONthe retrolaminar block will not be made for postoperative analgesia
Interventions
By using ultrasound probe, the needle with in-plane , after seeing vertebral lamina, the local anesthetic will injectate
Eligibility Criteria
You may qualify if:
- years old
- ASA 1, 2, 3 patients
- undergoing lumvar vertyebra surgery
You may not qualify if:
- pregnant woman
- child
- patint wiht cognitive disfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kırıkkale Univercity Faculty of Medicine Hospital
Kırıkkale, 71450, Turkey (Türkiye)
Related Publications (1)
Peker K, Aydin G, Gencay I, Saracoglu AG, Sahin AT, Ogden M, Peker SA. The effect of preemptive retrolaminar block on lumbar spinal decompression surgery. Eur Spine J. 2024 Nov;33(11):4253-4261. doi: 10.1007/s00586-024-08219-4. Epub 2024 Jun 17.
PMID: 38886235DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevser Peker
Kırıkkale University Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assitant professor
Study Record Dates
First Submitted
December 19, 2019
First Posted
December 24, 2019
Study Start
May 1, 2020
Primary Completion
May 30, 2021
Study Completion
May 30, 2021
Last Updated
April 7, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share