The Effect of Erector Spinae Plane Block (ESPB) on Pediatric Pain Management Following Posterior Spinal Fusion (PSF) Surgery
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Compare Oral Morphine Equivalents and Benzodiazepine Doses used in the first 72 hours after surgery among patients who have a ESPB with standard postoperative pain protocols versus those with standard protocols alone.
Overview
Brief Summary
This study is being done to better understand the efficacy of an erector spinae plane block (ESPB) in pain management for children with Adolescent Idiopathic Scoliosis or Neuromuscular Scoliosis undergoing Posterior Spinal Fusion surgery. The study team is trying to find out if receiving the ESPB leads to less pain and less need for pain medication after surgery.
The ESPB involves an injection of a local anesthetic, ropivacaine, into your child's back muscles to help block pain signals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Adolescent Idiopathic Scoliosis (AIS) or neuromuscular scoliosis
- •Undergoing Posterior Spinal Fusion (PSF) Surgery
Exclusion Criteria
- •Patients with forms of scoliosis other than AIS or NM Scoliosis.
- •Patients undergoing a spinal deformity correction surgery other than Posterior Spinal Fusion Surgery
- •Allergy or other contraindication to erector spinae plane block (ESPB) with Ropivacaine patients who are taking pre-operative opioids
Arms & Interventions
ESPB with Ropivacaine + standard postoperative pain protocol
Erector spinae plan block (ESPB) with Ropivacaine and standard postoperative pain protocol
Intervention: Ropivacaine Hydrocloride (Drug)
No ESPB + standard postoperative pain protocol
No erector spinae plane block (ESPB) or type of injection and standard posteropative pain protocol
Outcomes
Primary Outcomes
Compare Oral Morphine Equivalents and Benzodiazepine Doses used in the first 72 hours after surgery among patients who have a ESPB with standard postoperative pain protocols versus those with standard protocols alone.
Time Frame: Change from Baseline to 72 hours after surgery.
Institutional pain management protocol: patients have a hydromorphone patient-controlled analgesia pump until post-operative day 1 and as needed (PO) methadone two times a day, as well as PO oxycodone every 4 hours as needed for moderate pain and IV hydromorphone every 2 hours as needed for severe pain. PO diazepam is available every 6 hours for muscle spasms. The oral morphine equivalents and benzodiazepine doses used in the first 72 hours after surgery will be the primary method of assessing postoperative pain and muscle spasms respectively.
Evaluate if combining ESPBs with standard postoperative pain protocols reduce postoperative pain scores in the first 24 hours postoperatively as compared to standard protocols alone.
Time Frame: From Baseline to 24 hours after surgery.
Pain will be measured on a numerical scale from zero to ten, with zero being no pain at all and ten being the worst pain you have ever felt. Scores will be gathered at multiple time points the day of surgery, and post-op day 1, 2 and 3. We will take the average pain score. These numerical pain scores will be the secondary method of assessing postoperative pain.
Assess time to clearance from physical therapy among patients who have a ESPB with standard postoperative pain protocols versus those with standard protocols alone.
Time Frame: From postoperative day 1 to physical therapy clearance.
Time to clearance from physical therapy (PT) is a measure that demonstrates the amount of time required to obtain a functional level of mobilization after surgery. This mobilization is often pain limited. For neuromuscular patients with mobility limitations, aim 3 will be measured based on when patients are cleared by PT for safe discharge home. We will measure time to clearance in both groups.
Secondary Outcomes
No secondary outcomes reported