the Effect of Retrolaminar Block on Postoperative Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: retrolaminar block tecnique

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kırıkkale, Turkey, 71450
    • Kırıkkale Univercity Faculty of Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kırıkkale University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 22, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: retolaminar block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No