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the Effect of Retrolaminar Block on Postoperative Pain

Sponsor
Kırıkkale University (Other)
Overall Status
Completed
CT.gov ID
NCT04209907
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12.9
Actual Duration (Months)
4.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: retrolaminar block tecnique
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-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
Actual Primary Completion Date :
May 30, 2021
Actual Study Completion Date :
May 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. change of pain throughout postoperative 24 hours [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kırıkkale Univercity Faculty of Medicine Hospital Kırıkkale Turkey 71450

Sponsors and Collaborators

  • Kırıkkale University

Investigators

  • Principal Investigator: Kevser Peker, Kırıkkale University Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kevser Peker, assitant professor, Kırıkkale University
ClinicalTrials.gov Identifier:
NCT04209907
Other Study ID Numbers:
  • retolaminar block
First Posted:
Dec 24, 2019
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative

Study Results

No Results Posted as of Apr 7, 2022