the Effect of Retrolaminar Block on Postoperative Pain

NCT ID: NCT04209907

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-05-30

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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

the group which retrolaminar block will be approved

the retrolaminar block will be made for postoperative analgesia

Group Type: ACTIVE_COMPARATOR

retrolaminar block tecnique

Intervention Type: OTHER

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

the group which retrolaminar block will not be approved

the retrolaminar block will not be made for postoperative analgesia

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

retrolaminar block tecnique

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kırıkkale University

OTHER

Sponsor Role: lead

Responsible Party

Kevser Peker

assitant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevser Peker

Role: PRINCIPAL_INVESTIGATOR

Kırıkkale University Faculty of Medicine

Locations

Kırıkkale Univercity Faculty of Medicine Hospital

Kırıkkale, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 38886235 (View on PubMed)

Other Identifiers

retolaminar block

Identifier Type: -

Identifier Source: org_study_id