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

NCT06728046 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-11

No results posted yet for this 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.

Conditions

  • Idiopathic Scoliosis
  • Erector Spinae Plane Block
  • Patient Controlled Analgesia

Interventions

OTHER

ESPB

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

DEVICE

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Ren Liao, M.D. · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06728046 on ClinicalTrials.gov