Lumbar Spinal Stenosis, Lumbar Spine Degeneration, Lumbar Spine Instability
Conditions
Keywords
Lumbar spinal fusion surgery, Postoperative analgesia, Erector spina plan block
Brief summary
Lumbar spinal surgery is one of the operations performed for the treatment of leg and back pain. Severe pain may occur at postoperative period in patients following lumbar fusion surgery. The ultrasound(US) guided erector spina plan block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. Visualization of sonoanatomy with US is simple and the spread of local anesthetic solution can be seen easily the deep fascia of the erector spinae. In the literature, it has been reported that ESPB provides effective analgesia after lumbar spine surgery. The surgical team visualizes the transverse processes and erector spina muscle during surgery. The aim of this study is to compare US-guided ESPB and surgical infiltrative ESPB for postoperative analgesia management after lumbar spinal fusion surgery.
Detailed description
Lumbar spinal surgery is one of the operations performed for the treatment of leg and back pain. Severe pain may occur at postoperative period in patients following lumbar fusion surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced. Parenteral opioids are generally preferred in the management of acute postoperative pain. However opioids have undesired adverse events such as nausea, vomiting, itching, sedation and respiratory depression (opioid-related adverse events). Regional anesthesia techniques may be preferred as the use of ultrasound (US) increases in daily anesthesia practice. The ultrasound(US) guided erector spina plan block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. Visualization of sonoanatomy with US is simple and the spread of local anesthetic solution can be seen easily the deep fascia of the erector spinae. In the literature, it has been reported that ESPB provides effective analgesia after lumbar spine surgery. The surgical team visualizes the transverse processes and erector spina muscle during surgery. The erector spina plane block can be performed by administering local anesthetic solution between the transverse process and the erector spina muscle. The aim of this study is to compare US-guided ESPB and surgical infiltrative ESPB for postoperative analgesia management after lumbar spinal fusion surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).
Interventions
DRUGSurgical ESPB
In group IE, transverse processes will be palpated before sewing the surgical incision by the surgery team. The local anesthetic solution will be administered after the needle contacts the transverse process and its location is confirmed by negative aspiration. Once the needle tip will be placed within the interfacial plane and after careful aspiration to rule out intravascular needle placement, 5 mL of solution will be injected the proper injection site. Local anesthetic solution will be injected at 4 levels along the surgical incision line. A dose of 0.25% bupivacaine 20 mL will be injected in each side (total 40 mL). Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.
DRUGUS guided ESPB
US guided ESP block will be performed. US probe will be placed longitudinally 2-3 cm lateral to the L3 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle will be inserted cranio caudal direction and then for correction of the needle 2 ml saline will be enjected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block in each side (total 40 mL). Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.
Sponsors
Bursa City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The patient, investigators and the pain nurse who performs postoperative pain evaluation will not know the group.
Intervention model description
There are three models for this study. The first group is ultrasound guided erector spinae plane block group. The second one is surgical injection erector spinae plane block group. The third one is the no intervention control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) classification I-II * 2 or 3 levels of posterior lumbar spinal fusion surgery under general anesthesia
Exclusion criteria
* history of bleeding diathesis * receiving anticoagulant treatment * known local anesthetics and opioid allergy * infection of the skin at the site of the needle puncture * pregnancy or lactation * patients who do not accept the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative opioid consumption | Change from Baseline Opioid Consumption for Postoperative 24 hours. | Postoperative opioid consumption will be evaluated at postoperative 24 h period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scores (VAS) | postoperative 1, 2, 4, 8, 16 and 24 hours | VAS score (0 = no pain, 10 = the most severe pain felt) |
Countries
Turkey (Türkiye)
Outcome results
None listed