Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorStanford University

About this trial

Providing effective analgesia after spinal fusion for idiopathic scoliosis remains a challenge with significant practice variation existing among high volume spine surgery centers. Even in the era of multimodal analgesia, opioids are the primary analgesics used for pain control after pediatric scoliosis surgery, but have multiple known adverse effects. The erector spinae plane block (ESPB) is a newly described fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Additionally, there are case reports describing the ESPB as part of a multi-modal analgesic plan in adult degenerative spine surgery as well as adult spinal deformity surgery, demonstrating effective analgesia and no clinical motor blockade. Although it is known that the inflammatory reaction plays a crucial role in the mechanism of acute pain after major surgery, the effectiveness of the current regional approach on inflammatory response is not well studied.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA I-III

Diagnosed with Idiopathic scoliosis

Undergoing single-stage posterior spinal instrumentation and fusion

Disqualifiers

Thorascopic tethering procedure

Two-stage procedure

Abnormal developmental profile

Congenital/neuromuscular scoliosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erector Spinae Plane Blockade

    Procedure/Surgery

    The ESPB is fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Its proposed mechanism of action is via blockade of the dorsal and ventral rami of the thoracic spinal nerves and sympathetic fibers.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Erector Spinae Plane Blockade TreatmentExperimental treatment 1 intervention
Group B: Erector Spinae Plane Blockade Control - Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Length of Stay (LOS)

Determine if bilateral surgical placed ESPBs will decrease length of stay in the pediatric ICU and the hospital. LOS and decrease postoperative opioid consumption.)

Time frame
Through hospital stay, an average of 5 days
2

Postoperative Opioid Consumption

Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)

Time frame
Through hospital stay, an average of 5 days
3

Maximum lidocaine plasma concentration [Cmax]

Measure daily serial plasma lidocaine levels from ESPB catheters

Time frame
Through hospital stay, an average of 5 days
4

Patient-Reported Pain Scores

Patients will be asked on a daily basis by the research staff to report pain scores on a scale of 1-10 (1 signifying no pain to 10 signifying the worse pain).

Time frame
Through hospital stay, an average of 5 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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