Clinical trial NCT06728046: Erector Spinae Plane Block v.s Patient Controlled Analgesia in Correction Surgery for Idiopathic Scoliosis
Official title: Analgesic Effects of Ultrasound-Guided Erector Spinae Plane Block v.s Patient Controlled Analgesia in Correction Surgery for Idiopathic Scoliosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Idiopathic Scoliosis
Erector Spinae Plane Block
Patient Controlled Analgesia
Keywords: Erector Spinae Plane Block
Patient Controlled Analgesia
Idiopathic Scoliosis Correction Surgery
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Resting numerical rating scale (NRS) pain scores
timeFrame: 2 hours postoperatively
Secondary outcomes:
measure: Severe complications
timeFrame: 30 days postoperatively
measure: Postoperative resting NRS pain scores
timeFrame: 3 days after surgery
measure: Postoperative NRS pain scores during movement
timeFrame: 3 days after surgery
measure: Postoperative opioids consumption
timeFrame: 30 days postoperatively
measure: Time to initiate functional exercises
timeFrame: 30 days postoperatively
measure: Total length of hospital stay
timeFrame: 7 days after discharge
measure: Postoperative length of hospital stay
timeFrame: 7 days after discharge
measure: Total hospital cost
timeFrame: 7 days after discharge
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Ren Liao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: