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NCT Number: NCT06471348

Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine

A randomized controlled trial (RCT) investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion (PSF) for AIS is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 0.25% bupivacaine with epinephrine for patients aged 10 to 17, with 128 patients randomly assigned to one of two arms: liposomal bupivacaine or 0.25% bupivacaine with epinephrine.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spinal Fusion

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥10 years old and ≤17 years old at assessment
  • Diagnosis of Adolescent Idiopathic Scoliosis
  • Planned surgical treatment of progressive spinal deformity with posterior spinal fusion

Exclusion criteria

  • Diagnosis of neuromuscular, syndromic, or congenital scoliosis
  • History of known allergy to local anesthesia
  • Chronic pre-operative opioid consumptions
  • Any other analgesic treatment for chronic pain before surgery
  • Psychiatric or neurological disorders
  • Cannot fluently read or speak English

Treatment and study plan

Bupivacaine liposome injectable suspension

Drug

EXPAREL is a milky white too off-white aqueous suspension available as single-dose vials. Each mL contains 13.3 mg of bupivacaine, which is contained in multivesicular liposomes.

Other names: EXPAREL

Bupivacaine Hydrochloride and Epinephrine Injection

Drug

Sensorcaine-MPF with Epinephrine 1:200,000 is a clear, colorless to slightly yellow solution available as single-dose vials. Each mL contains bupivacaine hydrochloride, 0.005 mg epinephrine, and 0.5 mg sodium metabisulfite (antioxidant), and 0.2 mg anhydrous citric acid (stabilizer).

Other names: Sensorcaine-MPF with Epinephrine 1:200,000

Primary outcomes

  1. Total amount of morphine equivalents per kilogram

    Time frame: 72 hours postoperatively

    Total amount of morphine equivalents per kilogram during the first 72 hours postoperatively.

Secondary outcomes

  1. Numeric Rating Scale (NRS) pain scores

    Time frame: 72 hours postoperatively

    The average Numeric Rating Scale pain score (on a scale of 0-10) during the first 72 hours postoperatively will be computed from at most six values typically obtained every four to six hours following surgery. The higher the score, the higher the experienced pain of the individual.

  2. Pain, functional ability, and mental health scores

    Time frame: 1-, 6-, 12-, and 24-months postoperatively

    SRS-22r scores at 1-, 6-, 12-, and 24-months post-operatively. The Scoliosis Patient Questionnaire Version 22r (SRS-22r) is a patient-reported outcome instrument with 22 questions that evaluates the impact of scoliosis and surgery on patient quality of life. Scores from the SRS-22r are compiled into five domain scores: function, pain, self-image, mental health, and satisfaction with management of scoliosis. Each domain score is reported on a scale form 1-5. The lower the score, the worse the outcome.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 24, 2024
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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