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Erector Spine Block for Back Surgery

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ClinicalTrials.gov Identifier: NCT03214536
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr M. B. Breebaart, University Hospital, Antwerp

Brief Summary:
In spine surgery postoperative pain can often be severe and difficult to treat.With the use of ultrasound, the performance of plane blocks and other techniques like root blocks, facet infiltration have become possible without the use of either unreliable " pop-techniques" or the use of x-ray.The erector spinae block was recently described as a safe and simple and safe technique for neuropathic pain and acute post surgical pain, with effect on the dorsal rami of the spinal nerves and with promising results. In this observational pilot study we want to test the influence of these to blocks on the postoperative pain and opioid consumption after spine fusion.

Condition or disease Intervention/treatment Phase
Spine Disease Regional Anaesthesia Procedure: erector spinae block Drug: Ropivacaine Procedure: Spine surgery Procedure: anesthesia Not Applicable

Detailed Description:

In 10-15 patients undergoing back surgery (laminectomy or back surgery with lumbar pedicle screw placement or revision back surgery), will be asked to give informed consent to receive a bilateral lumbar erector spinae block before surgery. In this population it will be clear after 10-15 patients if there is a beneficial effect since these patients normally require a substantial amount of postoperative opioids because of significant postoperative pain.

The blocks will be performed by experts in the field of ultrasound guided locoregional anaesthesia in a separate block room with ultrasound after placement of an iv line and application of standard monitoring (ECG, NIBP, saturation)

Description of block performance according to Chinn et al but at a lumbar level:

The patient will be placed in the lateral or sitting position. With a curve array probe or a high frequency linear probe, depending on the BMI of the patient, will be placed in a longitudinal position 2-3 cm lateral of the vertebral column. The transverse processes of the vertebrae at the (mid) level of surgery, the erector spinae muscle and the psoas muscle are identified. Depending on the depth a 5 or 8 cm 22 G ultrasound needle (pajunk) will be inserted in an in plane technique in a cephalad to caudad direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, 20 ml of ropivacaine 0,375% will be injected behind the erector spinae muscle. The same procedure will be repeated on the contralateral side.

Sensory loss of the posterior dermatomes and dermatomes of the anterior roots of the spinal nerves (lumbar plexus, upper leg) will be tested Motor function of the legs will be evaluated with a Bromage (0-3) score.

General anaesthesia will then be induced in a standardized way with propofol, sufentanyl and rocuronium. The maintenance of anaesthesia and the procedure will be performed according to protocol.

After surgery analgesia will be provided with nsaid when applicable and 1000 mg paracetamol IV 4 times daily combined with a PCA (patient controlled analgesia) pump depending on the site:

  • AZ klina protocol: PCA piritramide/dhbp pump: 0ml/h, 2 mg bolus, 20 minutes lockout
  • UZA protocol: Morphine/dhbp pump: 0ml/h 1 mg bolus, 8minutes lock out) and Pain scores (NRS, 0=no pain 10= worst pain ever), will be tested on the post anesthesia care unit every hour and according to hospital postoperative protocol at the ward during the fist 24 hours.

The amount and frequency of the opioid usage of the first 24 hours will be extracted out of the PCA pump. In patients without a block, opioid consumption is mostly expected between 25-40 mg morphine/24h (loading dose excluded) according to weight. We expect to see a substantial decrease (at least 50 %) in opioid consumption.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: observational feasibility trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Erector Spine Block in Patients Undergoing Back Surgery, Observational Feasibility Trial of the Effect on Postoperative Pain-scores and Opioid Consumption
Actual Study Start Date : June 25, 2017
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: erector spinae block
bilateral erector spine block with 20 ml 0,375% ropivacaine
Procedure: erector spinae block
bilateral injection of local anaesthetic between the erector spinae muscle and the transverse process

Drug: Ropivacaine
injection of 20 ml ropivacaine 0.375 % bilateral by erector spinae block
Other Name: naropin

Procedure: Spine surgery
Surgery of lumbar spine

Procedure: anesthesia
general anesthesia




Primary Outcome Measures :
  1. 24 hour opioid consumption [ Time Frame: 24 hours from injection ( T0) ]
    cumulative opioid consumption first 24 hours after block performance


Secondary Outcome Measures :
  1. sensory block [ Time Frame: 30 minutes after block performance ]
    loss of cold sensation of anterior and posterior roots of lumbar spinal nerve dermatomes

  2. motor block [ Time Frame: 30 minutes after block performance ]
    motor function of legs by Bromage scale

  3. pain scores [ Time Frame: 24 postoperative at regular intervals ]
    numeric rating scores postoperative pain ( 0-10)



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

Inclusion Criteria:

  • Patients planned for laminectomy or back surgery with lumbar pedicle screw placement or revision back surgery

Exclusion Criteria:

  • patient refusal, bleeding disorder, infection

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): NCT03214536


Locations
Belgium
AZ KLina
Brasschaat, Antwerp, Belgium
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: margaretha breebaart, PhD University Hospital, Antwerp

Responsible Party: Dr M. B. Breebaart, principal investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03214536     History of Changes
Other Study ID Numbers: EC nr 17/09/097
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr M. B. Breebaart, University Hospital, Antwerp:
spine surgery
regional anaesthesia
opioid consumption
acute postoperative pain

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents