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

NCT ID: NCT06658054

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2026-11-30

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.

Detailed Description

Regional anesthetic techniques, including interfascial plane blocks, have demonstrated success in postoperative pain control and improved patient satisfaction. Erector spinae plane blocks (ESPB) are a relatively new regional anesthetic modality, which have shown potential for perioperative pain control in lumbar spinal surgery. This study aims to investigate whether adding dexmedetomidine and dexamethasone as adjuncts to bupivacaine in ESPB improves analgesia and reduces opioid usage in lumbar spinal fusion patients receiving multimodal pain regimens. It will also assess the impact of these adjuncts on postoperative nausea and vomiting (PONV) and anti-emetic medication requirements. The study employs a randomized, double-blind design, with participants divided into two groups: ESPB without adjuvants (Group A) and ESPB with dexmedetomidine and dexamethasone (Group B). Primary outcomes include opioid consumption at 24 hours postoperatively, while secondary outcomes involve opioid consumption at various time points and visual analog scale (VAS) pain scores. The results of this investigation will provide valuable insights into the efficacy of ESPB with adjuncts in postoperative pain management in lumbar spinal fusion patients.

Conditions

Lumbar Degenerative Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A (control)

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).

Group Type: ACTIVE_COMPARATOR

Control (Standard treatment)

Intervention Type: DRUG

Patient will receive standard ESPB with bupivacaine and normal saline

Group B (Intervention)

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.

Group Type: ACTIVE_COMPARATOR

Adjuvant analgesia

Intervention Type: DRUG

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

Interventions

Adjuvant analgesia

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

Intervention Type: DRUG

Control (Standard treatment)

Patient will receive standard ESPB with bupivacaine and normal saline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Paul S. Lee

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Paul S Lee

Role: CONTACT

pauls.lee@med.usc.edu

(323) 442-7400

Ram K Alluri, MD

Role: CONTACT

ram.alluri@med.usc.edu

(323) 442-5300

Other Identifiers

HS-23-00440

Identifier Type: -

Identifier Source: org_study_id