Pain, Postoperative
Conditions
Keywords
thoracolumbar, spine, pain, postoperative
Brief summary
The investigators are looking to recruit patients into a study demonstrating the effectiveness of a superficial nerve block involving the thoracolumbar interfascial plane (TLIP) in reducing postoperative pain in those undergoing spinal surgery
Detailed description
Patients undergoing spine surgery with or without fusion experience a great deal of pain especially in the first 3 days after surgery. Spine surgeons are looking for ways to reduce the pain that you experience. Anesthesiologists have introduced a procedure, called a TLIP block to provide pain relief. The block involves injecting local anesthetic (numbing pain medication) in the lower back around the site of the surgery. This block has been used by other surgeons for other types of surgeries in the past and has been shown to work. To determine how effective the block is, the investigators are conducting this investigational study where pain severity in patients who receive one of 2 kinds of local anesthetic or placebo are compared
Interventions
DRUGLiposomal bupivacaine
Use of liposomal bupivicaine as intraoperative local anesthesia
DRUGBupivacaine Injection
Use of bupivicaine as intraoperative local anesthesia
DRUGPlacebo
Use of saline as placebo for local anesthesia
Sponsors
The Cooper Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult patients undergoing multilevel lumbar spine surgery, age 18-75
Exclusion criteria
* Opioid use disorder, previous spine surgery, non english-speaking patients, patients with anticipated communication disorders, patients with coagulopathy, prisoners, children, pregnant women, single level hemilaminectomy with or without discectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in postoperative pain | 24-48 hours | Using Visual Analog Scales on a scale of 0-10, where 0 is no pain and 10 is the worst pain |
| Total postoperative opioid requirements | 1-5 days | Using daily MME |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Ambulation | 1-5 days | Daily physical therapy evaluations where ambulation is recorded and time from surgery is documented |
| Length of Hospital Stay | 1-5 days | Number of postoperative days |
Countries
United States
Contacts
Primary ContactChristopher Bilbao, DO
Backup ContactPatricia Feineigle, PhD
Outcome results
None listed