Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery

NCT ID: NCT04730531

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2024-12-01

Brief Summary

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.

Conditions

Postoperative Pain; Spinal Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Arm

Local infiltration with 0.25% bupivacaine and epinephrine

Group Type: EXPERIMENTAL

Local infiltration with 0.25% bupivacaine and epinephrine

Intervention Type: PROCEDURE

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.

Control Arm

Placebo of equal volume injectable saline

Group Type: PLACEBO_COMPARATOR

Placebo of equal volume injectable saline

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Craig Birch

Instructor of Orthopedic Surgery, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig Birch, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lauren E Hutchinson, MPH

Role: CONTACT

Lauren.Hutchinson@childrens.harvard.edu

(617) 919-1632 ext. 91632

Facility Contacts

Lauren E Hutchinson, MPH

Role: primary

Lauren.Hutchinson@childrens.harvard.edu

617-919-1632

Other Identifiers

IRB-P00037508

Identifier Type: -

Identifier Source: org_study_id