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Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery

Primary Purpose

Postoperative Pain, Spinal Fusion

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Local infiltration with 0.25% bupivacaine and epinephrine
Placebo of equal volume injectable saline
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Arm

Control Arm

Arm Description

Local infiltration with 0.25% bupivacaine and epinephrine

Placebo of equal volume injectable saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 26, 2021
Last Updated
August 23, 2022
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04730531
Brief Title
Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery
Official Title
Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Spinal Fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Local infiltration with 0.25% bupivacaine and epinephrine
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Placebo of equal volume injectable saline
Intervention Type
Procedure
Intervention Name(s)
Local infiltration with 0.25% bupivacaine and epinephrine
Intervention Description
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
Intervention Name(s)
Placebo of equal volume injectable saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) pain score
Description
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.
Time Frame
24 hours post-operatively
Secondary Outcome Measure Information:
Title
Average use of morphine equivalents
Description
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.
Time Frame
24 hours post-operatively
Title
Scoliosis Patient Questionnaire - Version 30 (SRS-30)
Description
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.
Time Frame
1-, 6-, and 12-months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren E Hutchinson, MPH
Phone
(617) 919-1632
Ext
91632
Email
Lauren.Hutchinson@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Birch, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren E Hutchinson, MPH
Phone
617-919-1632
Email
Lauren.Hutchinson@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Craig Birch, MD
First Name & Middle Initial & Last Name & Degree
Daniel Hedequist, MD
First Name & Middle Initial & Last Name & Degree
Timothy Hresko, MD
First Name & Middle Initial & Last Name & Degree
Grant Hogue, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery

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