Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04730531
• Other study ID #: IRB-P00037508
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: August 2022
• Source: Boston Children's Hospital
• Contact: Lauren E Hutchinson, MPH
• Phone: (617) 919-1632
• Email: Lauren.Hutchinson[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Spinal Fusion

Intervention

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 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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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