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

NCT04370951 | Unknown DMC

• 1 other identifier: 1/378/2088
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Surgery

Keywords

erector spinae plane block; post operative recovery

Outcome Measures

Primary Outcomes (1)

• QoR 15 score

  a objective assessment of quality of recovery post surgery

  24 hours post operatively

Secondary Outcomes (2)

• AUC of VRS Pain score versus time

  24 hours post op

• time to administration of first rescue analgesia after the block

  24 hours post op

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

no ESP block, standardised multimodal analgesia

Interventions

Erector Spinae Plane Block - Ultrasound guided PROCEDURE

20mls 0.25% Levobupivicaine ultrasound guided bilaterally

Erector Spinae Plane Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Mater Misericordiae University Hospital: lead

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, D07 R2WY, Ireland

RECRUITING

Related Publications (2)

• Finnerty D, Ni Eochagain A, Ahmed M, Poynton A, Butler JS, Buggy DJ. A randomised trial of bilateral erector spinae plane block vs. no block for thoracolumbar decompressive spinal surgery. Anaesthesia. 2021 Nov;76(11):1499-1503. doi: 10.1111/anae.15488. Epub 2021 Apr 20.

  PMID: 33878196 DERIVED

• Finnerty DT, Buggy DJ. Efficacy of the erector spinae plane (ESP) block for quality of recovery in posterior thoraco-lumbar spinal decompression surgery: study protocol for a randomised controlled trial. Trials. 2021 Feb 17;22(1):150. doi: 10.1186/s13063-021-05101-2.

  PMID: 33596968 DERIVED

Study Officials

• Donal Buggy, MB Bch Bao

  Professor of Anaesthesia and Perioperative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer in Anaesthesia

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: May 1, 2020
• Primary Completion: October 30, 2020
• Study Completion: January 3, 2021
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IE (1)