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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESPB Group | Experimental | Participants will receive ultrasound-guided ESPB preoperatively, using 40 ml of 0.3% ropivacaine. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESPB | Other | Participants will receive ultrasound-guided ESPB preoperatively, using 40 ml of 0.3% ropivacaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Severe complications | The incidence of severe complications are categorized into five grades based on severity: Grade I (resolved with temporary treatment, e.g., postoperative nausea and vomiting), Grade II (prolonged hospital stay required, e.g., pneumonia requiring antibiotics), Grade III (life-threatening events requiring intervention but recoverable during hospitalization, e.g., deep vein thrombosis), Grade IV (significant harm persisting 30 days or longer with a marked decrease in quality of life, e.g., postoperative cognitive dysfunction or delirium), and Grade V (death within 30 days postoperatively). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ren Liao, M.D. | Contact | +86-18980602177 | liaoren7733@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ren Liao, M.D. | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41239513 | Derived | 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. |
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Individual participant data (IPD) will be shared after de-identification.The shared data will include de-identified individual participant data, and metadata supporting the primary and secondary outcomes, as well as the study protocol.Data will be available beginning 6 months after publication of the main study results and ending 3 years following publication. Requests for data sharing should be directed to the corresponding author (liaoren7733@163.com). Upon approval of a formal proposal, a data-sharing agreement will be signed, and access will be granted through a secure datasharing platform.
Data will be available beginning 6 months after publication of the main study results and ending 3 years following publication.
Requests for data sharing should be directed to the corresponding author: liaoren7733@163.com.
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| ID | Term |
|---|---|
| D010323 | Passive Cutaneous Anaphylaxis |
| ID | Term |
|---|---|
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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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.
| 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. |
|
| 30 days postoperatively |
| Postoperative resting NRS pain scores | Resting NRS pain scores on postoperative days 1, 2, and 3 | 3 days after surgery |
| Postoperative NRS pain scores during movement | NRS pain scores during movement on postoperative days 1, 2, and 3. | 3 days after surgery |
| Postoperative opioids consumption | Opioids will be used as a rescue measure for acute pain, including sulfentanil, fentanil, and morphine. Sulfentanil or fentanil will be given to the participants in PACU when the NRS scores higher than 4. When a participant's resting NRS pain score exceeds 4 in the ward, 5 mg of morphine can be administered intravenously. If the effect is insufficient, an additional 5 mg may be given after 30 minutes, with a maximum daily dose of 20 mg. | 30 days postoperatively |
| Time to initiate functional exercises | Duration from hospital admission to the first attempt at mobilization, either preoperatively or postoperatively (in days) | 30 days postoperatively |
| Total length of hospital stay | Duration from hospital admission to discharge (in days) | 7 days after discharge |
| Postoperative length of hospital stay | Duration from the day of surgery to discharge (in days) | 7 days after discharge |
| Total hospital cost | Total hospital cost | 7 days after discharge |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |