Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery

Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery: A Randomized Control Trial

Non-opioid methods of pain management following posterior spinal fusion (PSF) have become increasingly popular given the rise of opioid abuse and opioid-related deaths. Orthopedic surgery remains one of the highest prescribing subspecialties. Local wound infiltration is an effective method of acute pain management following surgical intervention and is the standard in some surgical subspecialties, however, no randomized control trials (RCT) exist in the pediatric spine literature. This would be the first (RCT) to assess the use of local would infiltration in postoperative pain control following PSF for adolescent idiopathic scoliosis patients (AIS). The primary aim of this study is to investigate the efficacy of local wound infiltration with anesthetic agents in reduction of postoperative pain scores and post-operative opioid use during hospital admission following fusion surgery in AIS patients. The proposed single-center, double-blind prospective randomized study will be conducted by recruiting patients meeting the inclusion criteria of age 10-26 years and diagnosis of AIS undergoing posterior fusion surgery. Study participants will be randomized into either a local injection of 0.25% bupivacaine with epinephrine or a placebo of equal volume injectable saline. Patient-reported outcomes will be collected at 1-, 6-, 12- and 24-months postoperatively.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Spinal Fusion
• Intervention / Treatment: Procedure: Local infiltration with 0.25% bupivacaine and epinephrine; Procedure: Placebo of equal volume injectable saline

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren E Hutchinson, MPH; Phone Number: 91632 (617) 919-1632; Email: Lauren.Hutchinson@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Lauren E Hutchinson, MPH; Phone Number: 617-919-1632; Email: Lauren.Hutchinson@childrens.harvard.edu
      • Principal Investigator: Craig Birch, MD
      • Sub-Investigator: Daniel Hedequist, MD
      • Sub-Investigator: Timothy Hresko, MD
      • Sub-Investigator: Grant Hogue, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥10 years old and ≤17 years old at assessment
• Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Local infiltration with 0.25% bupivacaine and epinephrine	Procedure: Local infiltration with 0.25% bupivacaine and epinephrine; The local infiltration will occur in 2 stages, separated by 30 minutes. The first dose will be injected just prior to the final tightening of set screws, decortication, and bone grafting, and will occur via multiple small volume injections 1 centimeter apart into the paraspinal musculature. The second injection will occur at an interval of 30 minutes following deep fascial closure and similarly consist of multiple small volume injections at 1 centimeter intervals into the subcutaneous tissue and skin.
Placebo Comparator: Control Arm; Placebo of equal volume injectable saline	Procedure: Placebo of equal volume injectable saline; An equal volume of injectable saline will be used in the exact 2 stages as the treatment group. The first dose will be injected just prior to the final tightening of set screws, decortication, and bone grafting, and will occur via multiple small volume injections 1 centimeter apart into the paraspinal musculature. The second injection will occur at an interval of 30 minutes following deep fascial closure and similarly consist of multiple small volume injections at 1 centimeter intervals into the subcutaneous tissue and skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) pain score	The average Visual Analog Scale pain score (on a scale of 0-100 mm) during the first 24 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.	24 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average use of morphine equivalents	The average use of morphine equivalents per kilogram during the first 24 hours postoperatively. Morphine equivalents per kilogram will be also be obtained by reviewing post-anesthesia care unit reports.	24 hours post-operatively
Scoliosis Patient Questionnaire - Version 30 (SRS-30)	SRS-30 scores at 1-, 6-, and 12-months post-operatively. The Scoliosis Research Society (SRS-30) questionnaire is a 30-question patient reported instrument developed to evaluate health-related quality of life in patients with scoliosis. Scores from the SRS-30 are compiled into five domain scores: pain, function, 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.	1-, 6-, and 12-months post-operatively

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Craig Birch, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: IRB-P00037508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No