Erector Spine Block for Back Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Regional Anaesthesia; Spine Disease
• Intervention / Treatment: Procedure: erector spinae block; Drug: Ropivacaine; Procedure: Spine surgery; Procedure: anesthesia

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
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Brasschaat, Antwerp, Belgium
      • AZ KLINA
    • Edegem, Antwerp, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: naropin; Procedure: Spine surgery; Surgery of lumbar spine; Procedure: anesthesia; general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour opioid consumption	cumulative opioid consumption first 24 hours after block performance	24 hours from injection ( T0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensory block	loss of cold sensation of anterior and posterior roots of lumbar spinal nerve dermatomes	30 minutes after block performance
motor block	motor function of legs by Bromage scale	30 minutes after block performance
pain scores	numeric rating scores postoperative pain ( 0-10)	24 postoperative at regular intervals

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: margaretha breebaart, PhD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2017
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): October 30, 2017

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: acute postoperative pain; regional anaesthesia; spine surgery; opioid consumption
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: EC nr 17/09/097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No