Erector Spine Block for Back 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: NCT03214536|
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spine Disease Regional Anaesthesia||Procedure: erector spinae block Drug: Ropivacaine Procedure: Spine surgery Procedure: anesthesia||Not Applicable|
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)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||observational feasibility trial|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||August 30, 2017|
|Estimated Study Completion Date :||August 30, 2017|
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
injection of 20 ml ropivacaine 0.375 % bilateral by erector spinae block
Other Name: naropin
Procedure: Spine surgery
Surgery of lumbar spine
- 24 hour opioid consumption [ Time Frame: 24 hours from injection ( T0) ]cumulative opioid consumption first 24 hours after block performance
- sensory block [ Time Frame: 30 minutes after block performance ]loss of cold sensation of anterior and posterior roots of lumbar spinal nerve dermatomes
- motor block [ Time Frame: 30 minutes after block performance ]motor function of legs by Bromage scale
- pain scores [ Time Frame: 24 postoperative at regular intervals ]numeric rating scores postoperative pain ( 0-10)
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
|Contact: margaretha breebaart, PhDfirstname.lastname@example.org|
|Brasschaat, Antwerp, Belgium|
|Contact: David van Aken, MD 0032-3-6505110 David.Van.Aken@klina.be|
|University Hospital Antwerp||Recruiting|
|Edegem, Antwerp, Belgium, 2650|
|Contact: Margaretha Breebaart, md, pHd 0032-38213042 Margaretha.email@example.com|
|Contact: Vera Saldien, md 0032-38213000 vera.Saldien@uza.be|
|Principal Investigator:||margaretha breebaart, PhD||University Hospital, Antwerp|