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

NCT06728046 | Not Yet Recruiting

• 1 other identifier: WCH20241202
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Erector Spinae Plane Block; Patient Controlled Analgesia; Idiopathic Scoliosis Correction Surgery

Outcome Measures

Primary Outcomes (1)

• Resting numerical rating scale (NRS) pain scores

  The Numerical Rating Scale (NRS) is a tool for assessing pain intensity, allowing patients to rate their pain on a scale from 0 to 10, where 0 represents "no pain," 10 represents "the worst pain imaginable," and pain levels are categorized as 0 (no pain), 1-3 (mild pain), 4-6 (moderate pain), and 7-10 (severe pain).

  2 hours postoperatively

Secondary Outcomes (8)

• Severe complications

  30 days postoperatively

• Postoperative resting NRS pain scores

  3 days after surgery

• Postoperative NRS pain scores during movement

  3 days after surgery

• Postoperative opioids consumption

  30 days postoperatively

• Time to initiate functional exercises

  30 days postoperatively

Study Arms (2)

ESPB Group

EXPERIMENTAL

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

Other: ESPB

PCA Group

ACTIVE COMPARATOR

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.

Device: PCA

Interventions

ESPB OTHER

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

ESPB Group

PCA DEVICE

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.

PCA Group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 14 years or older, regardless of gender.
• Scheduled for scoliosis correction surgery.
• Signed informed consent from the participant or their legal guardian.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• Liao C, Zhong J, Lai X, Liao R. Analgesic effects of bilateral ultrasound-guided erector spinae plane block versus patient controlled intravenous analgesia in correction surgery for idiopathic scoliosis: study protocol for a randomized controlled trial. Perioper Med (Lond). 2025 Nov 14;14(1):127. doi: 10.1186/s13741-025-00622-9.

  PMID: 41239513 DERIVED

MeSH Terms

Interventions

Passive Cutaneous Anaphylaxis

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Officials

• Ren Liao, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ren Liao, M.D.

CONTACT

+86-18980602177; liaoren7733@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to differences in clinical management between the groups, investigators, participants, and clinical staff will be aware of group assignments. However, follow-up researchers and statisticians responsible for data analysis will remain blinded to the group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months after publication of the main study results and ending 3 years following publication.
• Access Criteria: Requests for data sharing should be directed to the corresponding author: liaoren7733@163.com.

Locations

CN (1)