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

NCT ID: NCT06728046

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-05-31

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.

Detailed Description

Scoliosis correction surgery involves large surgical wounds spanning multiple vertebrae, requiring sufficient analgesia to manage intense intraoperative stimulation and severe postoperative pain. Effective pain control in this context often necessitates potent opioids, such as morphine or equivalent drugs. Current perioperative analgesia strategies include intraoperative use of long-acting opioids (e.g., sufentanil, fentanyl) and patient-controlled analgesia (PCA) pumps for postoperative pain management, primarily involving opioids like sufentanil or morphine. However, opioids are associated with adverse effects such as nausea, vomiting, bowel obstruction, pruritus, dizziness, respiratory depression, opioid tolerance, and hyperalgesia, which can lead to suboptimal pain control and negatively impact patients' quality of life and postoperative recovery. There is a critical need for effective analgesic methods in scoliosis correction surgery that minimize opioid-related adverse effects, enhance the patient experience, and promote accelerated recovery.

The Erector Spinae Plane Block (ESPB) was first reported by Forero et al. in 2016 as an effective analgesic technique for rib-related neuropathic pain. Its mechanism involves the injection of local anesthetics into the fascial plane between the erector spinae muscle and the transverse process, allowing for the diffusion of the anesthetic to adjacent areas. ESPB exerts its primary analgesic effect through the posterior branches of spinal nerves and can further diffuse anteriorly to paravertebral and epidural spaces, and laterally across the costotransverse foramina, affecting nerve roots and visceral structures. This mechanism provides comprehensive analgesia. ESPB has since been widely applied in perioperative pain management for thoracic surgery, shoulder arthroscopy, breast surgery, abdominal surgery, cesarean sections, and urological procedures, as well as for acute and chronic pain conditions such as rib fractures, postherpetic neuralgia, burns, and cancer pain.

Studies have demonstrated that ESPB effectively reduces postoperative pain scores, decreases opioid consumption, delays the need for rescue analgesics, reduces the number of patients requiring rescue medication, and lowers the incidence of nausea and vomiting in spinal surgeries. Although there are limited case reports and clinical experience summarizing its perioperative analgesic effect in scoliosis correction surgery, preliminary findings suggest it is effective.

Based on the analgesic mechanism of ESPB and prior studies, we hypothesize that ESPB provides superior postoperative pain control compared to PCA, significantly reducing postoperative pain scores, perioperative opioid consumption, and associated adverse effects.

Conditions

Idiopathic Scoliosis; Erector Spinae Plane Block; Patient Controlled Analgesia

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESPB Group

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

Group Type: EXPERIMENTAL

ESPB

Intervention Type: OTHER

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

PCA Group

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.

Group Type: ACTIVE_COMPARATOR

PCA

Intervention Type: 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.

Interventions

ESPB

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

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ren Liao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ren Liao, M.D.

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Countries

China

Central Contacts

Ren Liao, M.D.

Role: CONTACT

Phone: +86-18980602177

Email: liaoren7733@163.com

Other Identifiers

WCH20241202

Identifier Type: -

Identifier Source: org_study_id