Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery

Scoliosis Clinical Trial

Official title:

Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944393
• Other study ID #: 673/22
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2023
• Source: Poznan University of Medical Sciences
• Contact: Malgorzata Domagalska, PhD
• Phone: 608762068
• Email: m.domagalska[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative pain after scoliosis correction surgery is severe and usually requires long-term intravenous opioid therapy. Local anesthetic options are limited and include intrathecal opioids and epidural analgesia. However, they are rarely used due to side effects and inconsistent efficacy. The investigators describe an opioid-sparing multimodal analgesia regimen with bilateral erector spinae plane blocks.

Description:

Posterior spinal fusion for scoliosis correction is extremely painful and usually requires long-term, high-dose opioid use for adequate perioperative analgesia. Neuromonitoring, i.e., motor-evoked and somatosensory-evoked potentials (SSEPs), are the current gold standard for preventing neurological damage. Local anesthesia is essential to multimodal analgesia, but options are limited. Intrathecal or epidural opioid injections of local anesthetics have been reported but are rarely used due to logistical complexity, side effects, and inconsistent analgesic efficacy. The erector spinae plane (ESP) block was first described in 2016 for thoracic neuropathic pain. It is a new interfacial plane technique. Easy to perform on patients without spinal deformities. It was successfully used for surgery in adults. However, even with ultrasound guidance, identifying bone markers in scoliosis patients is challenging. The investigators will treat patients for scoliosis with single-shot bilateral ESP blocks. The investigators aim to provide effective perioperative pain control and achieve intraoperative hemodynamic stability without compromising neuromonitoring.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Patients < 18 years old undergoing scoliosis surgery

Exclusion Criteria:

• refusal to participate
• > 18 yo
• Chronic opioid use
• localized infection

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder of Spine
• Pediatric Anesthesia
• Regional Anesthesia
• Scoliosis
• Spinal Diseases

Intervention

Drug:
• Ropivacaine 0.2% Injectable Solution
Ultrasound-guided Erector Spine Plane block with 10 mL 0.5% ropivacaine
• Normal saline 0.9% Injectable Solution
Ultrasound-guided Erector Spine Plane block with 10 mL 0.9% normal saline

Locations

Country	Name	City	State
Poland	Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznan, Poland	Poznan	Wielkopolska

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score	NRS (numerical rating scale) score (0- no pain to 10 worst pain)	Within 30 minutes of emergence from anesthesia
Primary	pain score - 60 minutes	NRS (numerical rating scale) score (0- no pain to 10 worst pain)	Within 60 minutes of emergence from anesthesia
Primary	pain score - 90 minutes	NRS (numerical rating scale) score (0- no pain to 10 worst pain)	Within 90 minutes of emergence from anesthesia
Primary	pain score - 120 minutes	NRS (numerical rating scale) score (0- no pain to 10 worst pain)	Within 120 minutes of emergence from anesthesia
Primary	pain score - 6 hours	NRS (numerical rating scale) score (0- no pain to 10 worst pain)	Within 6 hours of emergence from anesthesia
Primary	pain score - 12 hours	NRS (numerical rating scale) score (0- no pain to 10 worst pain)	Within 12 hours of emergence from anesthesia
Primary	pain score - 24 hours	NRS (numerical rating scale) score (0- no pain to 10 worst pain)	Within 24 hours of emergence from anesthesia
Primary	pain score - 48 hours	NRS (numerical rating scale) score (0- no pain to 10 worst pain)	Within 48 hours of emergence from anesthesia
Secondary	total opioid consumption within first 24 hours	Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is <4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record.	Second day following the procedure
Secondary	opioid consumption - 48 hours	Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is <4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record.	Within 48 hours of emergence from anesthesia
Secondary	Nausea and Vomiting	This is a yes/no binary outcome measure defined by administration of any antiemetic drug in the post-anesthesia care unit.	Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (0-48 hours postoperativly)
Secondary	NLR -12 hours	neutrophil/limphocyte ratio	12 hours postoperatively
Secondary	PLR -12 hours	platelet/limphocyte ratio	12 hours postoperatively
Secondary	NLR - 24 hours	neutrophil/limphocyte ratio	12 hours postoperatively
Secondary	PLR - 24 hours	platelet/limphocyte ratio	12 hours postoperatively