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Clinical trial

Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block for Pain Management Following Lumbar Spinal Fusion Surgery

ID
Name
BursaCityHospital
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. 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.
Trial arms
Trial start
2022-11-28
Estimated PCD
2023-08-15
Trial end
2023-09-15
Status
Completed
Treatment
Surgical 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.
Arms:
Group IE= Surgical Injection ESPB
US 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.
Arms:
Group UE= US guided ESPB
Size
90
Primary endpoint
Postoperative opioid consumption
Change from Baseline Opioid Consumption for Postoperative 24 hours.
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The patient, investigators and the pain nurse who performs postoperative pain evaluation will not know the group.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}
Updated at
2023-09-21

1 organization

2 products

3 indications

Organization
Bursa City Hospital
Product
Surgical ESPB
Indication
Lumbar Spine Instability
Indication
lumbar spinal stenosis
Indication
Degenerative Disc Disease
Product
US guided ESPB