NCT04730531

Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery

Status unknown NA Last updated 26 August 2022

What this trial tests

NA trial testing Local infiltration with 0.25% bupivacaine and epinephrine in Postoperative Pain in 100 participants. Status unknown.

Timeline

2 June 2022

Primary endpoint
1 December 2023

1 December 2024

Quick facts

Lead sponsor	Boston Children's Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	2 June 2022
Primary completion	1 December 2023
Estimated completion	1 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Local infiltration with 0.25% bupivacaine and epinephrine
• Placebo of equal volume injectable saline

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →
• Spinal Fusion — all drugs for Spinal Fusion →

Sponsor

Boston Children's Hospital

Who can join

Adults 10 to 17, any sex, with Postoperative Pain or Spinal Fusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.