Erector Spinae Plan Block (ESPB) with Dexmedetomidine and Dexamethasone in Lumbar Spine Fusion

NCT06658054 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: HS-23-00440
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study wants to understand if using a pre-operative anesthetic injection could contribute to better pain relief after the surgery. This injection is referred to as an erector spinae plane block (ESPB, or "Block" for short). In the past, blocks have been commonly used to alleviate different types of pain, including pain following lumbar spine surgery, but our investigators are curious to study if adding two additional commonly used drugs could improve pain relief following surgery when used together. This possibility for improvement in pain management is important for our doctors to study because they want to find ways to reduce the amount of pain medication required after surgery. We try to assess if one treatment is better than the other by looking into the amount of pain medication used immediately after the surgery (up to five times within the first 2 days; this is usually done by reviewing progress notes) and by asking patients if they can share with us their pain experienced at different times during their stay at the hospital and at 2-weeks after their procedure.

Conditions

Lumbar Degenerative Disease

Keywords

analgesia; ESPB; erector spinae plane block; dexmedetomidine; dexamethasone; bupivacaine; randomized; blinded; postoperative; opioid; PONV; nausea; vomitting; fusion

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption

  measured in morphine milligram equivalents (MME)

  24 hours postoperatively

Study Arms (2)

Group A (control)

ACTIVE COMPARATOR

Patients will receive an erector spinae plane block (ESPB) with 20 cc solution per single-shot injection comprised of 0.25% bupivacaine and 0.9% normal saline under ultrasound guidance to be administered bilaterally (40 cc total).

Drug: Control (Standard treatment)

Group B (Intervention)

ACTIVE COMPARATOR

Patients will receive ESPB with 20cc solution per single-shot injection comprised of 0.25% bupivacaine, 25mcg dexmedetomidine, and 5mg dexamethasone under ultrasound guidance to be administered bilaterally (40 cc total). This is in addition to the bupivacaine.

Drug: Adjuvant analgesia

Interventions

Adjuvant analgesia DRUG

Patients will receive adjuvant dexmedetomidine (25mcg) and dexamethasone (5mg) in addition to bupivacaine.

Group B (Intervention)

Control (Standard treatment) DRUG

Patient will receive standard ESPB with bupivacaine and normal saline

Group A (control)

Eligibility Criteria

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

You may qualify if:

• Medically optimized patients undergoing 1-3 level lumbar fusion surgery for treatment of degenerative lumbar spinal pathologies
• Aged 18 years or older
• English-speaking patients

You may not qualify if:

• Patients with surgical indications for infection, malignancy, or trauma
• women who are pregnancy or breastfeeding
• Patients with respiratory compromise
• Patients who are smokers
• Patients with allergies to local anesthetics, and/or opioid medications

Sponsors & Collaborators

• University of Southern California: lead

MeSH Terms

Conditions

Agnosia; Postoperative Nausea and Vomiting; Nausea

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting

Central Study Contacts

Paul S Lee

CONTACT

(323) 442-7400; pauls.lee@med.usc.edu

Ram K Alluri, MD

CONTACT

(323) 442-5300; ram.alluri@med.usc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Spine Surgeon
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 26, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 26, 2024

Record last verified: 2024-10