NCT04500613

Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis

Completed NA Results posted Last updated 27 December 2024

What this trial tests

NA trial testing Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone in Pain, Postoperative in 24 participants. Completed in 2 December 2022.

Timeline

22 February 2021

Primary endpoint
28 November 2022

2 December 2022

Quick facts

Lead sponsor	Hospital for Special Surgery, New York
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	22 February 2021
Primary completion	28 November 2022
Estimated completion	2 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone
• No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →
• Opioid Use — all drugs for Opioid Use →
• Recruitment — all drugs for Recruitment →

Sponsor

Hospital for Special Surgery, New York

Who can join

Adults 10 to 19, any sex, with Pain, Postoperative or Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients Who Receive Bilateral, Pre-incision ESPB Primary · through study completion, an average of 1 year

number who receive the intervention and complete all assessments

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	9
No ESPB	12

Rate of Recruitment Secondary · through study completion, an average of 1 year

Number enrolled and allocated to specific group

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	12
No ESPB	12

Blinding Assessment Secondary · 24 hours after surgery

Based on Bang's Blinding Index. Patients' ability to determine whether or not they received the ESPB. The success of patient blinding in each group will be quantified using the Bang Blinding Index which ranges from -1 to 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in or guessed the wrong group, respectively. This value is obtained by asking patients which group they believe they were randomly assigned to.

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	0	-.30 – .30
No ESPB	-0.33	-.63 – -0.04

Number of Participants Unable to Receive ESPB Block. Secondary · Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery

Number of participants who were randomized to receive the ESPB block, but were unable to receive the block. The no ESPB group were randomized not to get the ESPB block, leading to 0 instances of missed ESPB block.

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	2
No ESPB	0

Attrition Secondary · through study completion, an average of 1 year

Number of patients who enroll but do not receive the intervention and/or study assessments.

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	3
No ESPB	0

Incidence of Intra- and Postoperative Complications Attributed to ESPB Secondary · During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery

Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	0
No ESPB	0

Pain Scores at Rest and Movement Secondary · PACU (Post Anesthesia Care Unit, hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (an average of 4 days)

Measured by Numeric Rating Scale (NRS) pain at rest and with movement (0 being no pain and 10 being as bad as you can imagine). NRS was collected for each participant, Mean and Standard Deviations are found below.

NRS upon PACU Arrival

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	3.64	± 3.93
No ESPB	3.58	± 4.19

NRS at 8 Hours

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	4	± 3.37
No ESPB	2.5	± 1.62

NRS at 12 Hours

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	3.3	± 2.45
No ESPB	3	± 3.36

NRS at rest at 24 hours

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	3.55	± 1.63
No ESPB	2.42	± 2.19

NRS with Movement at 24 Hours

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	5.82	± 2.44
No ESPB	5	± 2.66

NRS at rest at Discharge

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	3.36	± 1.5
No ESPB	3	± 1.95

NRS with movement at Discharge

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	4.09	± 2.07
No ESPB	3.18	± 1.66

Total Opioid Consumption Secondary · 0-24 hours after surgery (OME within 24 hrs)

Measured in mean oral morphine equivalents (OME)

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	78.23	± 31.52
No ESPB	53.89	± 27.68

Time to First Opioid Use Secondary · Up to 24 hours after surgery

Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	178	43 – 309
No ESPB	94	57.5 – 246.5

Opioid Related Side Effects Secondary · 24 hours after surgery

Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS). Frequency of each symptom within the cohort was assessed.

Fatigue

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	3
No ESPB	9

Drowsiness

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	6
No ESPB	7

Concentration

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	1
No ESPB	2

Nausea

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	7
No ESPB	10

Dizziness

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	6
No ESPB	8

Constipation

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	0
No ESPB	1

Itching

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	4
No ESPB	2

Urination

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	0
No ESPB	0

Patient/Parent Satisfaction With Pain Management Secondary · At hospital discharge (an average of 4 days)

Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)

Patient

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	10	7 – 10
No ESPB	8	7 – 10

Parent

Group	Value	95% CI
ESPB With Bupivacaine and Dexamethasone	10	9 – 10
No ESPB	9	8 – 10

Sponsor's own description

Pediatric spinal fusion (PSF) surgery is a painful procedure that can treat adolescent idiopathic scoliosis (AIS). One technique that can potentially reduce patients' pain levels and need for opioid medication is the ultrasound-guided Erector Spinae Plane Block (ESPB). The ESP block is a technique that involves injecting an anesthetic medication into the muscles of the lower back on both sides of the spine. Previous studies have shown that ESPB application led to a reduction in opioid use, and there is one pediatric case report of ESPB use in two patients undergoing PSF. However, there is still lack of evidence that the ESPB technique is feasible and effective in the pediatric patient population.

The present study is designed to be the first randomized controlled trial to evaluate the role of ESPB in pediatric spinal fusion surgery and the role of ESPB within an enhanced recovery pathway.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.