Erector Spine Block for Back Surgery

Spine Disease Clinical Trial

Official title:

Erector Spine Block in Patients Undergoing Back Surgery, Observational Feasibility Trial of the Effect on Postoperative Pain-scores and Opioid Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214536
• Other study ID #: EC nr 17/09/097
• Status: Completed
• Phase: N/A
• Start date: June 25, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: November 2018
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Regional Anaesthesia
• Spinal Diseases
• Spine Disease

Intervention

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

Procedure:
• Spine surgery
Surgery of lumbar spine
• anesthesia
general anesthesia

Locations

Country	Name	City	State
Belgium	AZ KLina	Brasschaat	Antwerp
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour opioid consumption	cumulative opioid consumption first 24 hours after block performance	24 hours from injection ( T0)
Secondary	sensory block	loss of cold sensation of anterior and posterior roots of lumbar spinal nerve dermatomes	30 minutes after block performance
Secondary	motor block	motor function of legs by Bromage scale	30 minutes after block performance
Secondary	pain scores	numeric rating scores postoperative pain ( 0-10)	24 postoperative at regular intervals