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Lumbar Erector Spinae Plane Block for Back Surgery (LUMBES)

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: NCT03825198
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dr M. B. Breebaart, University Hospital, Antwerp

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


Condition or disease Intervention/treatment Phase
Pain, Postoperative Anaesthesia Surgery Nerve Block Anesthesia, Local Back Pain Spinal Fusion Procedure: Erector spinae plane block Drug: Levobupivacaine 0,25% 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 Phase 3

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blind randomised
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Prospective Randomized Double Blind Trial of the Efficacy of a Bilateral Lumbar Erector Spinae Block on the 24h Morphine Consumption After Posterior Lumbar Interbody Fusion Surgery.
Estimated Study Start Date : July 10, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2020

Arm Intervention/treatment
Active Comparator: ESB group

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
Ultrasound guided deposition infiltration between a lumbar transverse proces and the erector spine muscle
Other Name: Locoregional anaesthesia

Drug: Levobupivacaine 0,25%
20 ml levobupivacaine 0,25% used for the infiltration between the transverse process and the erector spinal muscle
Other Name: chirocaine

Procedure: spine fusion
fusion of lumbar vertebral body on 1 or two levels

Drug: Sufentanil
opioid used for the preoperative analgesia for back surgery during general anaesthesia ( 15 mag)
Other Name: sufenta

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

Drug: Rocuronium Bromide
muscle relaxant used during general anaesthesia ( 0,5 mg/kg)
Other Name: sermon

Drug: sevoflurane
inhalation aesthetic used for the maintenance of general anaesthesia

Drug: paracetamol
postoperative drug for analgesia ( 1 gram 4/day)

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

Drug: morphine pca
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
Other Name: patient controlled analgesia

Drug: Dexamethasone
drug given during general anaesthesia to prevent postoperative nausea
Other Name: aacidexam

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

Sham Comparator: SHAM group
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
Ultrasound guided deposition infiltration between a lumbar transverse proces and the erector spine muscle
Other Name: Locoregional anaesthesia

Procedure: spine fusion
fusion of lumbar vertebral body on 1 or two levels

Drug: NaCL 0,9%
20 ml solution used for the infiltration between the transverse process and th erector spinal muscle

Drug: Sufentanil
opioid used for the preoperative analgesia for back surgery during general anaesthesia ( 15 mag)
Other Name: sufenta

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

Drug: Rocuronium Bromide
muscle relaxant used during general anaesthesia ( 0,5 mg/kg)
Other Name: sermon

Drug: sevoflurane
inhalation aesthetic used for the maintenance of general anaesthesia

Drug: paracetamol
postoperative drug for analgesia ( 1 gram 4/day)

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

Drug: morphine pca
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
Other Name: patient controlled analgesia

Drug: Dexamethasone
drug given during general anaesthesia to prevent postoperative nausea
Other Name: aacidexam

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




Primary Outcome Measures :
  1. 24 hour morphine consumption [ Time Frame: 24 hours ]
    total milligrams (0-150) of morphine used in the first 24 hours after surgery, extracted out of the pca pump data.


Secondary Outcome Measures :
  1. Intraoperative sufentanyl requirement ( [ Time Frame: 2-5 hours ]
    total Intravenous administered sufentanyl in micrograms during surgery(10-100)

  2. Morphine consumption 72 hours [ Time Frame: 72 hours ]
    total milligrams of morphine used in 72 hours after surgery (0-450), extracted out of the pca pump data

  3. NRS pain scores [ Time Frame: at regular intervals and defined movement until 72 hours after surgery ]
    Numeric rating scale pain score (in numbers) and rest (0= no pain10 =worst thinkable pain)

  4. Quality of recovery score (QoR-40) [ Time Frame: day 1 and day 3 postoperatively ]
    score in numbers of mental and psychological well being scored by list of questions (minimal score 20-maximum score 200). A high score indicates a better/faster recovery, and is inversely correlated with hospital stay

  5. time to mobilisation to chair [ Time Frame: 8-72 hours ]
    movements (mobilisation to chair) in hours after surgery

  6. time to 20 meter walking [ Time Frame: 8-72 hours ]
    movement 20 meter walking in hours after surgery


Other Outcome Measures:
  1. expected preoperative pain score (NRs° [ Time Frame: before surgery ( moment of inclusion) ]
    Numeric rating scale pain score (in numbers). pain that people expect before they have surgery.



Information from the National Library of Medicine

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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:

  • - 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

Exclusion Criteria:

  • 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)

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): NCT03825198


Contacts
Layout table for location contacts
Contact: margaretha breebaart, MD PhD 003238213865 margaretha.breebaart@uza.be
Contact: Olivier defre, MD 003238213042 olivier.defre@uza.be

Locations
Layout table for location information
Belgium
AZ KLina Recruiting
Brasschaat, Antwerp, Belgium
Contact: David van Aken, MD    0032-3-6505110    David.Van.Aken@klina.be   
University Hospital Antwerp Recruiting
Antwerp, Belgium, 2650
Contact: Margaretha Breebaart, MD, PhD    003238213042    margaretha.breebaart@uza.be   
Contact: Olivier Defre, MD    003238213042      
Sponsors and Collaborators
Dr M. B. Breebaart

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr M. B. Breebaart, senior member of staff anesthesiology department, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03825198    
Other Study ID Numbers: B300201837508
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Pain, Postoperative
Pain
Neurologic Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Acetaminophen
Dexamethasone
Dexamethasone acetate
Ketorolac
Ketorolac Tromethamine
Sufentanil
Morphine
Bromides
Anesthetics
Propofol
Sevoflurane
Levobupivacaine
Rocuronium
BB 1101
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones