Erector Spinae Plane Block, Lumbar Spine Surgery
Conditions
Brief summary
The goal of this study is to evaluate the analgesic efficacy of bilateral erector spinae plane (ESP) blocks after lumbar and lumbo-sacral spine surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We are aiming to investigate how ESP blocks, performed under ultrasound guidance at the T12 vertebral level, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until patient discharge from hospital. These primary outcome measures will be compared between a treatment group of participants, who will receive ESP blocks and a control group who will receive a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements
Interventions
PROCEDUREBilateral lumbar erector spinae plane block
Bilateral lumbar erector spinae plane blocks performed under ultrasound guidance
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Spine surgery at or below the L1 vertebral level * Midline surgical approach
Exclusion criteria
* Previous lumbar or lumbo-sacral surgery with or without hardware placement * Evidence of dura pathology (including CSF leak) * Spine tumor * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores | During hospitalization, typically lasting between 1 and 5 days | Pain scores will be measured and documented as part of routine clinical care using the standard NRS (numerical rating scale, ranging from 0= no pain to 10= worst imaginable pain). Pain assessments will be made several times per day starting pre-operatively and continued during hospitalization. |
| Perioperative opiate consumption | During hospitalization, typically lasting between 1 and 5 days | Peri-operative opiate consumption will be assessed by measuring opiate administration intra- and post-operatively (during hospitalization) and expressed as oral morphine equivalents (OMEs). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORClaas Siegmueller, MD PhD MBA
University of California, San Francisco
Outcome results
None listed