Erector Spine Block for Back Surgery

NCT ID: NCT03214536

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-25
• Study Completion Date: 2017-10-30

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.

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.

Conditions

Spine Disease; Regional Anaesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

erector spinae block

bilateral erector spine block with 20 ml 0,375% ropivacaine

Group Type: EXPERIMENTAL

erector spinae block

Intervention Type: PROCEDURE

bilateral injection of local anaesthetic between the erector spinae muscle and the transverse process

Ropivacaine

Intervention Type: DRUG

injection of 20 ml ropivacaine 0.375 % bilateral by erector spinae block

Spine surgery

Intervention Type: PROCEDURE

Surgery of lumbar spine

anesthesia

Intervention Type: PROCEDURE

general anesthesia

Interventions

erector spinae block

bilateral injection of local anaesthetic between the erector spinae muscle and the transverse process

Intervention Type: PROCEDURE

Ropivacaine

injection of 20 ml ropivacaine 0.375 % bilateral by erector spinae block

Intervention Type: DRUG

Spine surgery

Surgery of lumbar spine

Intervention Type: PROCEDURE

anesthesia

general anesthesia

Intervention Type: PROCEDURE

Other Intervention Names

naropin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Dr M. B. Breebaart

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

margaretha breebaart, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

AZ KLina

Brasschaat, Antwerp, Belgium

University Hospital Antwerp

Edegem, Antwerp, Belgium

Countries

Belgium

Other Identifiers

EC nr 17/09/097

Identifier Type: -

Identifier Source: org_study_id