Ultrasound vs. Surgical ESP Block With Bupivacaine-Dexmedetomidine in Lumbar Fusion Surgery

NCT06958718 | Completed Phase 4

• 1 other identifier: M762
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Operative Pain

Keywords

lumbar spinal surgery; Pain; ESPB; Ultrasound guided ESPB; Surgical ESPB; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• QAQStatic VAS score one hour postoperatively.

  Visual Analog Scale (VAS) tool used to measure pain of patients after surgery, consist of 100mm length scale where 0 = "no pain" and 100 = "worst imaginable pain". static VAS score to be obtained one hour after surgery.

  one hour after surgery

Secondary Outcomes (14)

• Postoperative static VAS scores.

  At 48 hours after the block

• Postoperative dynamic VAS scores.

  At 48 hours after the block

• Time consumed in the block.

  the time After starting blocking procedure till finishing procedure up to 1 hour

• The time of the first postoperative analgesic request.

  the time After blocking procedure till the first request of analgesia up to 48 hours

• Total postoperative needs of nalbuphine.

  At first 24 hours after ESP block.

Study Arms (2)

Ultrasound Guided erector spinae plane block (UB)

ACTIVE COMPARATOR

the block will be done using ultrasound device after wound closure

Procedure: Ultrasound Guided erector spinae plane block (UB); Drug: Dexmedetomidine; Drug: Bupivacaine Hcl 0.5% Inj

Surgical erector spinae plane block (SB)

ACTIVE COMPARATOR

the block will be done surgically before wound closure

Procedure: Surgical erector spinae plane block (SB); Drug: Dexmedetomidine; Drug: Bupivacaine Hcl 0.5% Inj

Interventions

Ultrasound Guided erector spinae plane block (UB) PROCEDURE

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.

Ultrasound Guided erector spinae plane block (UB)

Surgical erector spinae plane block (SB) PROCEDURE

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.

Surgical erector spinae plane block (SB)

Dexmedetomidine DRUG

0.5 μg/kg dexmedetomidine added to block solution

Also known as: precedex

Surgical erector spinae plane block (SB); Ultrasound Guided erector spinae plane block (UB)

Bupivacaine Hcl 0.5% Inj DRUG

40 ml Bupivacaine HCL

Also known as: Marcaine

Surgical erector spinae plane block (SB); Ultrasound Guided erector spinae plane block (UB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- American Society of Anesthesiologists (ASA) I-Ⅲ patients scheduled for elective two or three levels of lumbar spinal fusion surgeries by the same surgical team.

You may not qualify if:

• Patient refusal.
• Body mass index \> 30 kg/m2
• Significant renal, hepatic, or cardiovascular diseases.
• History of allergy to one of the study drugs (local anesthetics, opioids, or dexmedetomidine).
• Any contraindications to regional anesthesia like local infection or abnormal coagulation function.
• Pregnant or breastfeeding women.
• Chronic opioid use, history of chronic pain, or cognitive disorders.
• Emergent surgeries.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

Al Fayyum, Fayoum Governorate, 63514, Egypt

Location

Related Publications (10)

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  PMID: 32890299 BACKGROUND

• Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.

  PMID: 31033625 BACKGROUND

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  PMID: 25766366 BACKGROUND

• Qiu Y, Zhang TJ, Hua Z. Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review. J Pain Res. 2020 Jul 1;13:1611-1619. doi: 10.2147/JPR.S256205. eCollection 2020.

  PMID: 32669870 BACKGROUND

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  PMID: 34593667 BACKGROUND

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  PMID: 32752602 BACKGROUND

• Bajwa S, Kulshrestha A. Dexmedetomidine: an adjuvant making large inroads into clinical practice. Ann Med Health Sci Res. 2013 Oct;3(4):475-83. doi: 10.4103/2141-9248.122044.

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  PMID: 35528286 BACKGROUND

• Bianconi M, Ferraro L, Ricci R, Zanoli G, Antonelli T, Giulia B, Guberti A, Massari L. The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. Anesth Analg. 2004 Jan;98(1):166-172. doi: 10.1213/01.ANE.0000093310.47375.44.

  PMID: 14693613 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Dexmedetomidine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mohamed A Hamed, MD

  Fayoum University Hospital

  PRINCIPAL INVESTIGATOR

• Mohamed A Elsaeed, MD

  Fayoum University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 6, 2025
• Study Start: May 6, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)