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Clinical Trials in China / NCT06728046
Starting soon Not applicable

Erector Spinae Plane Block v.s Patient Controlled Analgesia in Correction Surgery for Idiopathic Scoliosis

NCT06728046 · tracked via the Priya Life Science China tracker
Sponsor
West China Hospital
Phase
Not applicable
Started
2025-01-01
Last updated
2024-12-11

Condition(s) studied

Idiopathic ScoliosisErector Spinae Plane BlockPatient Controlled Analgesia

Investigational drug(s) / intervention(s)

ESPBPCA

ESPB: Participants will receive ultrasound-guided ESPB preoperatively, using 40 ml of 0.3% ropivacaine.

PCA: Participants will receive postoperative PCA with a formulation of 200 µg sufentanil diluted to 100 ml. The PCA settings will include a background dose of 3 ml/hour, a lockout time of 15 minutes, and a bolus dose of 2 ml.

Study summary

Scoliosis correction surgery involves extensive surgical wounds, intense intraoperative stimulation, and severe postoperative pain, often necessitating the use of potent opioids. However, there is a critical clinical need for effective pain management strategies that both ensure sufficient analgesia and minimize opioid-related adverse effects. The Erector Spinae Plane Block (ESPB) has shown promise as an effective analgesic technique, but its application in scoliosis correction surgery has not been reported.We hypothesize that ESPB provides superior postoperative analgesia compared to patient-controlled intravenous analgesia (PCA) pumps. Specifically, ESPB is expected to significantly reduce postoperative pain scores, decrease perioperative opioid consumption, and mitigate opioid-related side effects.

This study is a randomized controlled trial involving 40 participants undergoing scoliosis correction surgery, randomized into two groups: the ESPB group and the PCA group. The primary outcome measure is the resting pain score at 2 hours postoperatively, which will be used to evaluate the efficacy of ESPB. Secondary outcomes include perioperative opioid consumption and the incidence of opioid-related adverse effects. The study aims to provide evidence for ESPB as an innovative and effective method for postoperative analgesia in scoliosis correction surgery.

Eligibility

Sex
ALL
Min age
14 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Aged 14 years or older, regardless of gender. * Scheduled for scoliosis correction surgery. * Signed informed consent from the participant or their legal guardian. Exclusion Criteria: * Allergy to local anesthetics such as ropivacaine. * Family history of malignant hyperthermia. * Severe systemic diseases affecting the heart, lungs, liver, or kidneys. * Neurological or psychiatric disorders. * Communication difficulties, such as hearing impairment or speech disorders. * Concurrent participation in other clinical studies. * Other conditions deemed unsuitable for participation by the investigators.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
West China Hospital, Sichuan University Chengdu Sichuan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06728046 on ClinicalTrials.gov ↗ ← All trials in China