NCT05705739

Brief Summary

Retrolaminar block (RLB) and erector spinae plane block (ESPB) are alternative approaches to paravertebral block (PVB) and are advantageous in that they are easier and safer techniques compared with the traditional PVB. These blocks are considered to be compartment blocks or interfascial plane blocks. In these approaches, local anesthetics are assumed to penetrate the superior costotransverse ligament and reach the paravertebral space, although the needle tip is not advanced into the paravertebral space. the study aim to evaluate and compare the analgesic efficacy of retrolaminar plane block and erector spinae plane block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

February 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

January 20, 2023

Last Update Submit

October 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual analogue pain scale

    score from 0-10 (0 mean no pain and 10 the worst pain )

    24 hour

Secondary Outcomes (2)

  • Time of first post operative analgesic request.

    24 hour

  • Total analgesic consumption

    24 hour

Study Arms (2)

Retrolaminar plane block

EXPERIMENTAL
Procedure: retrolaminar block

ESPB

EXPERIMENTAL
Procedure: ESPB

Interventions

curved probe will be placed 1-1.5 cm lateral to the target spinous process after identification of the lamina, the needle will be advanced caudally until it contacts the lamina

Retrolaminar plane block
ESPBPROCEDURE

curved probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T8. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle.

ESPB

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age18-60.
  • Both genders.
  • hepatobiliary surgery.
  • ASA I-III.

You may not qualify if:

  • Drug allergy.
  • Morbid obesity (BMI \>40 kg/m2).
  • Psychiatric disorder.
  • Opiod dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, Minya Governorate, 61511, Egypt

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and ICU

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 31, 2023

Study Start

February 10, 2023

Primary Completion

July 1, 2023

Study Completion

August 1, 2023

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations