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

ConditionsIdiopathic ScoliosisErector Spinae Plane BlockPatient Controlled Analgesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorWest China Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 14 years or older, regardless of gender.

Scheduled for scoliosis correction surgery.

Signed informed consent from the participant or their legal guardian.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ESPB

    Other intervention

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

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: ESPB GroupExperimental treatment 1 intervention
Group B: PCA GroupActive comparator 1 intervention

Trial outcomes

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).

Time frame
2 hours postoperatively

Secondary outcomes

1

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).

Time frame
30 days postoperatively
2

Postoperative resting NRS pain scores

Resting NRS pain scores on postoperative days 1, 2, and 3

Time frame
3 days after surgery
3

Postoperative NRS pain scores during movement

NRS pain scores during movement on postoperative days 1, 2, and 3.

Time frame
3 days after surgery
4

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.

Time frame
30 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov

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