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OpenTrials
Completed

NCT Number: NCT04209907

the Effect of Retrolaminar Block on Postoperative Pain

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırıkkale Univercity Faculty of Medicine Hospital

Kirikkale, 71450, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnant woman
  • child
  • patint wiht cognitive disfunction

Treatment and study plan

retrolaminar block tecnique

Other

By using ultrasound probe, the needle with in-plane , after seeing vertebral lamina, the local anesthetic will injectate

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study title

the Effect of Retrolaminar Block on Post Operative Analgesia After Lumbar Vertebra Surgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2019
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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