Lumbar Erector Spinae Plane Block for Back Surgery

NCT03825198 | Unknown Phase 3 DMC

• 1 other identifier: B300201837508
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Title: A prospective randomized double blind trial of the efficacy of a bilateral lumbar erector spinae block on the 24 h morphine consumption after posterior lumbar interbody fusion surgery. Objectives: The primary objective is to study the influence of a bilateral erector spinae block on 24h morphine consumption. Endpoint: The primary endpoint is the 24 h morphine consumption in mg. Secondary endpoints are intraoperative sufentanil requirement, total morphine during first 72 postoperative hours, NRS pain scores in rest and defined movement (moving to chair) at regular time intervals and Quality of Recovery 40 score (QoR-40) at fixed time intervals day 1 and 3 postoperatively Population: Patients undergoing posterior lumbar interbody fusion ranging 1 - 3 levels Phase 3 Number of sites Enrolling participants: University Hospital Antwerp \&AZ KLINA Brasschaat Description of study agent: Bilateral erector spinae block: each block contains 20 ml levobupivacaine 0.25% + 5 mcg/ml epinephrine Study duration Until the required study population is met Participant duration 72 hours

Conditions

Pain, Postoperative; Anaesthesia; Surgery; Nerve Block; Anesthesia, Local; Back Pain; Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• 24 hour morphine consumption

  total milligrams (0-150) of morphine used in the first 24 hours after surgery, extracted out of the pca pump data.

  24 hours

Secondary Outcomes (6)

• Intraoperative sufentanyl requirement (

  2-5 hours

• Morphine consumption 72 hours

  72 hours

• NRS pain scores

  at regular intervals and defined movement until 72 hours after surgery

• Quality of recovery score (QoR-40)

  day 1 and day 3 postoperatively

• time to mobilisation to chair

  8-72 hours

Other Outcomes (1)

• expected preoperative pain score (NRs°

  before surgery ( moment of inclusion)

Study Arms (2)

ESB group

ACTIVE COMPARATOR

Erector Spinae plane block with 20 ml levobupivacaine 0,25% on each side. General anesthesia with 15 mcg sufentanil, 2-3 mg/kg propofol and 0,5 mg/kg Rocuronium Bromide during spine fusion surgery (1 or two intervertebral levels). Maintainance of general anesthesia with sevoflurane. Postoperative analgesia with Ketorolac (0,5 mg/kg), paracetamol 1000 mg (4 times/ day) and Morphine PCA. Dexamethasone is administered for the prevention of nausea.

Procedure: Erector spinae plane block; Drug: Levobupivacaine 0,25%; Procedure: spine fusion; Drug: Sufentanil; Drug: propofol; Drug: Rocuronium Bromide; Drug: sevoflurane; Drug: paracetamol; Drug: Ketorolac; Drug: morphine pca; Drug: Dexamethasone; Drug: Morphine

SHAM group

SHAM COMPARATOR

Erector Spinae plane block with 20 ml NaCl 0,9% on each side General anesthesia with 15 mcg sufentanil, 2-3 mg/kg propofol and 0,5 mg/kg Rocuronium Bromide during spine fusion surgery (1 or two intervertebral levels). Maintainance of general anesthesia with sevoflurane.Postoperative analgesia with Ketorolac (0,5 mg/kg, paracetamol 1000 mg 4times/ day and Morphne PCA .Dexamethasone is administered for the prevention of nausea.

Procedure: Erector spinae plane block; Procedure: spine fusion; Drug: NaCL 0,9%; Drug: Sufentanil; Drug: propofol; Drug: Rocuronium Bromide; Drug: sevoflurane; Drug: paracetamol; Drug: Ketorolac; Drug: morphine pca; Drug: Dexamethasone; Drug: Morphine

Interventions

Erector spinae plane block PROCEDURE

Ultrasound guided deposition infiltration between a lumbar transverse proces and the erector spine muscle

Also known as: Locoregional anaesthesia

ESB group; SHAM group

Levobupivacaine 0,25% DRUG

20 ml levobupivacaine 0,25% used for the infiltration between the transverse process and the erector spinal muscle

Also known as: chirocaine

ESB group

spine fusion PROCEDURE

fusion of lumbar vertebral body on 1 or two levels

ESB group; SHAM group

NaCL 0,9% DRUG

20 ml solution used for the infiltration between the transverse process and th erector spinal muscle

SHAM group

Sufentanil DRUG

opioid used for the preoperative analgesia for back surgery during general anaesthesia ( 15 mag)

Also known as: sufenta

ESB group; SHAM group

propofol DRUG

induction agent for general anaesthesia ( 2-3 mg/kg)

ESB group; SHAM group

Rocuronium Bromide DRUG

muscle relaxant used during general anaesthesia ( 0,5 mg/kg)

Also known as: sermon

ESB group; SHAM group

sevoflurane DRUG

inhalation aesthetic used for the maintenance of general anaesthesia

ESB group; SHAM group

paracetamol DRUG

postoperative drug for analgesia ( 1 gram 4/day)

ESB group; SHAM group

Ketorolac DRUG

non steroidal into inflammation drug used for postoperative analgesia (0,5 mg/kg)

ESB group; SHAM group

morphine pca DRUG

postoperative morphine pomp, controlled by the patient. ( bolus 1 mg, lockout 8 minutes) the solution contains morphine 1 mg/ml + dehydrobenzperidol 0,05 mg/ml

Also known as: patient controlled analgesia

ESB group; SHAM group

Dexamethasone DRUG

drug given during general anaesthesia to prevent postoperative nausea

Also known as: aacidexam

ESB group; SHAM group

Morphine DRUG

loading dose morhine 0,1 mg/kg at the end of surgery

ESB group; SHAM group

Eligibility Criteria

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

You may qualify if:

• \- Patients scheduled for 1-2 level posterior lumbar interfusion surgery in AZ KLINA Hospital or University of Antwerp Hospital (UZA) after approval of Ethical Committee until all required patients are included
• American Society of Anesthesiologist (ASA) score of 1 - 3
• Age 18 - 75 year
• Normal liver and renal function

You may not qualify if:

• Age \<18 years or mentally incompetent
• BMI \< 16 or BMI \> 35
• Allergy to one or more substances of the study medication (= levobupivacaine, dexamethasone, propofol, sufentanil, rocuronium, ketorolac, morphine, ketamine, DHBP, ondansetron, alizapride)
• Chronic strong opioid use (\>3 intakes per week)

Sponsors & Collaborators

• Dr M. B. Breebaart: lead

Study Sites (2)

AZ KLina

Brasschaat, Antwerp, Belgium

RECRUITING

University Hospital Antwerp

Antwerp, 2650, Belgium

RECRUITING

Related Publications (1)

• Breebaart MB, Van Aken D, De Fre O, Sermeus L, Kamerling N, de Jong L, Michielsen J, Roelant E, Saldien V, Versyck B. A prospective randomized double-blind trial of the efficacy of a bilateral lumbar erector spinae block on the 24h morphine consumption after posterior lumbar inter-body fusion surgery. Trials. 2019 Jul 17;20(1):441. doi: 10.1186/s13063-019-3541-y.

  PMID: 31315670 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Back Pain

Interventions

Levobupivacaine; Sufentanil; Propofol; Rocuronium; Sevoflurane; Acetaminophen; Ketorolac; Analgesia, Patient-Controlled; Dexamethasone; Calcium Dobesilate; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Acetanilides; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Analgesia; Anesthesia and Analgesia; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids, Fluorinated; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons

Central Study Contacts

margaretha breebaart, MD PhD

CONTACT

003238213865; margaretha.breebaart@uza.be

Olivier defre, MD

CONTACT

003238213042; olivier.defre@uza.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The medication for the sham block with NaCl or the local anaesthetic will be prepared by an independent medical caregiver who has no connection with the patient. The anaesthetics performing the block, the patient and the observation nurses/doctors collecting the data are masked. The solutions used are not distinguishable from each other.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: senior member of staff anesthesiology department

Model Details: double blind randomised

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: January 31, 2019
• Study Start: August 1, 2019
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)