the Effect of Retrolaminar Block on Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209907
• Other study ID #: retolaminar block
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: March 2022
• Source: Kirikkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• retrolaminar block tecnique
By using ultrasound probe, the needle with in-plane , after seeing vertebral lamina, the local anesthetic will injectate

Locations

Country	Name	City	State
Turkey	Kirikkale Univercity Faculty of Medicine Hospital	Kirikkale

Sponsors (1)

Lead Sponsor	Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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