NCT05792124

Brief Summary

The aim of this study is to compare the efficacy of erector spinae plane block (ESPB) and Retrolaminar Block on postoperative recovary quality and pain after lumbar spinal surgery

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

January 19, 2023

Last Update Submit

March 29, 2023

Conditions

Postoperative Pain

Keywords

Recovery Qualitypostoperative painErector spina plane blockRetrolaminar block

Outcome Measures

Primary Outcomes (1)

  • Qor-40 test (The recovery quality test)

    For this purpose, patients will be subjected to the Short Form-40- test, which is a short scale of postoperative recovery quality at first 24th hour.Minimum score is 40=bad ,maximum score is 200=good

    24th hour

Secondary Outcomes (2)

  • NRS (Numerical rating scale)

    30 minutes,1st hour,6th hour,12th hour and 24th hour

  • Postoperative pain

    30 minutes,1st hour,6th hour,12th hour and 24th hour

Study Arms (2)

ESP BLOCK

EXPERIMENTAL
Procedure: Erector spina area block

RLB BLOCK

ACTIVE COMPARATOR
Procedure: Retrolaminar block

Interventions

Erector spina area blockPROCEDURE

After anesthesia and surgical intervention, bilateral ESP passage will be performed with ultrasonography from the T10 level 3 cm lateral to the midline. After cleaning the area with povidone iodine before the block, T10 transverse output will be determined using a linear ultrasound probe. Local anesthetic will be applied to the erector spina with the use of the needle used for peripheral block procedures and transverse access. With the serum treatment from the local anesthesia application, the location of the needle will be correct with the hydrodissection method. After the location of the needle is confirmed, a mixture containing 20 ml of LA and serum will be applied and the same procedure will be repeated in the contralateral. 20 ml of total 40 ml LA is bupivacaine 0.5%, after 20 ml serum content.

ESP BLOCK
Retrolaminar blockPROCEDURE

The patient is in the prone position and the high-frequency linear ultrasound transducer is in parasagittal orientation, but the entry point is determined more medial than the ESP block. The needle entry point is 1-1.5 cm lateral to the targeted spinos process. The echogenic needle is advanced until it contacts the lamina in the craniocaudal plane and 0.5-1 for control. By giving cc 0.9 nacl solution, it is observed that the fluid is distributed between the erector spina muscle and the lamina. After the location of the needle is confirmed, a mixture of 20 ml of LA and saline will be applied and the same procedure will be repeated in the contralateral. 20 ml of total 40 ml LA will consist of bupivacaine 0.5% and 20 ml physiological saline.

RLB BLOCK

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing lumbar spinal surgery under elective conditions
  • ASA I-III
  • Between 18-75 ages

You may not qualify if:

  • refuse during registration
  • request to be dismissed from study
  • failure to give informed consent
  • emergency surgery
  • bleeding diathesis
  • Presence of contraindications to the LA agents used in this study chronic use of opioids psychiatric disorders the presence of infection at the injection site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University Faculty of Medicine

Aydin, 09010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Didar Kyenshilik, Resident doctor

CONTACT

+902564441256didarkyenshilik@gmail.com

Sinem Sarı Öztürk, Associate Professor

CONTACT

+902564441256sarisinem@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 19, 2023

First Posted

March 31, 2023

Study Start

January 31, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations

TU(1)