Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of the Erector Spinae Plane Block in Posterior Thoraco- Lumbar Spinal Decompression Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04370951
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Dylan Finnerty, Mater Misericordiae University Hospital

Brief Summary:

Spinal Surgery can be associated with significant post operative pain. This can be a considerable source of morbidity, resulting in a longer duration of in- hospital stay and increasing opiate requirements. As a result the patient experiences a more arduous recovery process.

Recently a new form of Regional Anaesthesia has been described for patients undergoing Spinal surgery. The Erector Spinae Plane Block involves depositing Local Anaesthetic under Ultra Sound guidance on top of the Transverse Process of the Spine and deep to the Erector Spinae Muscle. Patients who have had this procedure report lower pain scores and have a lesser opiate requirement in the post operative period.


Condition or disease Intervention/treatment Phase
Spinal Surgery Procedure: Erector Spinae Plane Block - Ultrasound guided Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of the Erector Spinae Plane (ESP) Block for Quality of Recovery in Posterior Thoraco-Lumbar Spinal Decompression Surgery: A Randomised Control Trial
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : January 3, 2021

Arm Intervention/treatment
Active Comparator: Erector Spinae Plane Block
Patients will receive a ESP block with 20mls 0.25% Levobupivicaine bilaterally, pre incision plus standardised multimodal analgesia
Procedure: Erector Spinae Plane Block - Ultrasound guided
20mls 0.25% Levobupivicaine ultrasound guided bilaterally

No Intervention: Control
no ESP block, standardised multimodal analgesia



Primary Outcome Measures :
  1. QoR 15 score [ Time Frame: 24 hours post operatively ]
    a objective assessment of quality of recovery post surgery


Secondary Outcome Measures :
  1. AUC of VRS Pain score versus time [ Time Frame: 24 hours post op ]
    Area under the VRS pain score versus time

  2. time to administration of first rescue analgesia after the block [ Time Frame: 24 hours post op ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Male and Female participants providing written informed consent, ASA grade 1- 4, age group 18 and over undergoing Posterior approach Spinal surgery involving 2 or more levels of decompression in the lumbar or thoracic regions.

-

Exclusion Criteria:Absence of informed written consent, pre existing infection at block site, severe coagulopathy, allergy to local anaesthesia, , previous history of opiate abuse, pre existing chronic pain condition, pre-existing dementia [because of need to co-operate in completing QoR-15 score day after surgery], decompression involving cervical levels of vertebrae, decompression due to queried or confirmed malignancy

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370951


Locations
Layout table for location information
Ireland
Mater Misericordiae University Hospital Recruiting
Dublin, Ireland, D07 R2WY
Contact: Dylan Finnerty, MB BCh BAO    018032286    anaes@mater.ie   
Contact: Donal Buggy, mb bch bao    018032285    anaes@mater.ie   
Sponsors and Collaborators
Mater Misericordiae University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Donal Buggy, MB Bch Bao Professor of Anaesthesia and Perioperative Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dylan Finnerty, Clinical Lecturer in Anaesthesia, Mater Misericordiae University Hospital
ClinicalTrials.gov Identifier: NCT04370951    
Other Study ID Numbers: 1/378/2088
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Case report forms,
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dylan Finnerty, Mater Misericordiae University Hospital:
erector spinae plane block
post operative recovery