At a glance
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Efficacy of Ultrasound-guided Versus Surgical Erector Spinae Plane Block With a Mixture of Bupivacaine and Dexmedetomidine in Lumbar Spinal Fusion Surgery: A Prospective Randomized Double-Blinded Clinical Trial.
In Brief
A Phase 4 clinical trial evaluating Ultrasound Guided erector spinae plane block (UB), Surgical erector spinae plane block (SB), and 2 other interventions for Post Operative Pain. Completed, enrolled 52 participants across 1 site.
Detailed Summary
Lumbar spine surgery causes intense post-op pain, peaking within 12 hours and improving by day three. Traditional spinal procedures involve extensive tissue dissection, leading to severe pain and potential complications like delayed mobilization, respiratory issues, and chronic pain. Effective pain management is crucial. Opioid-based relief is standard but comes with side effects (nausea, respiratory depression), increasing hospital stays and costs. Dexmedetomidine (DEX) is an alpha-2 adrenergic receptor agonist that enhances nerve block duration when combined with local anesthetics (LAs). It works by inhibiting sodium and potassium channels, leading to prolonged hyperpolarization. Regional nerve blocks, such as thoracic epidurals and fascial plane blocks, improve postoperative pain management and help reduce opioid use, minimizing complications. Various techniques, including ESP blocks, paravertebral Block (PVB), and Serratus anterior Block (SAB) have been explored for acute pain relief. The Erector Spinae Plane Block (ESPB), initially used for thoracic neuropathic pain, has expanded to thoracic, breast, and abdominal surgeries. The ESP block is done by injecting a local anesthetic between the transverse process and the erector spinae muscle. Ultrasound guidance helps visualize the spread of the anesthetic and the surrounding anatomy. Previous studies indicate that the ESP block can effectively relieve pain after lumbar spine surgery and may reduce postoperative opioid use when local anesthetics are applied to the wound and deep tissues. Based on this, performing the ESP block directly by the surgical team, using a local anesthetic between the erector spinae muscle and transverse process with direct view and free hand, may yield similar results to the ultrasound guided technique. The current study aims to evaluate the analgesic efficacy of Ultrasound-Guided Erector Spinae Plane Block in comparison with surgical Erector Spinae Plane Block using a mixture of bupivacaine and dexmedetomidine in lumbar Spinal fusion Surgeries.
Study Details
Timeline
Interventions
Ultrasound Guided erector spinae plane block (UB) with 40 ml Bupivacaine HCL mixed with 0.5 μg/kg dexmedetomidine .. After the surgical incision is closed and before extubation, while the patient remains in the prone position. A linear high-frequency transducer (L6-12 linear array transducer (6-12 MHz) on GE Healthcare logiq p7, made in Korea) will be positioned in a sagittal orientation, 4 cm lateral to the L3 transverse process. A 22 G × 88 mm block needle will be inserted in the craniocaudal direction, with the needle tip placed beneath the erector spinae muscle and above the hyperechoic transverse process. The needle tip position will be confirmed via saline injection. Once correct needle placement is verified, 40 mL of 0.25% bupivacaine, combined with 0.5 μg/kg dexmedetomidine 15 will be administered divided on both sides.
Surgical erector spinae plane block (SB) with 40 ml Bupivacaine HCL mixed with 0.5 μg/kg dexmedetomidine ..This volume will be divided into 8 injections, four 5 ml injections on each side. The surgeons will perform the block just before starting the wound closure stage. The surgical ESP block technique consists of injections at four bilateral levels, starting from one level above the operated vertebra and covering all surgical segments using a 22G × 88 mm needle. The needle will be inserted to contact the transverse process, and the injectate will be delivered between the erector spinae muscle and the transverse process at each level.
0.5 μg/kg dexmedetomidine added to block solution
40 ml Bupivacaine HCL