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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05944393
Other study ID # 673/22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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