Scoliosis Clinical Trial
Official title:
Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
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.
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznan, Poland | Poznan | Wielkopolska |
Lead Sponsor | Collaborator |
---|---|
Poznan University of Medical Sciences |
Poland,
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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