Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery

NCT04156581 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2019-1282
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Enhanced recovery pathways (ERPs) emphasize evidence-based, multimodal anesthetic and analgesic choices to minimize opioid consumption while providing adequate pain control after surgery. Although ERPs for spine surgery are now being described, few pathways include regional analgesia. The Erector Spinae Plane Block (ESPB) may represent a novel opportunity to incorporate regional analgesia into ERPs for spine surgery. To date, there is minimal data to support the utility of ESPB in spine surgery, and this block has not yet been evaluated in complex spine surgery. This study seeks to see whether ESPB will reduce opioid consumption and pain scores, and improve patient recovery during the first 24 hours after complex spine surgery when included in a comprehensive ERP.

Conditions

Opioid Use; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Intraoperative and Postoperative Opioid Consumption

  The total amount of opioid taken during surgery and 24 hours after surgery, measured in morphine milligram equivalent (MME).

  0-24 hours after surgery (intraoperative + immediately after surgery)

Secondary Outcomes (9)

• Numeric Rating Scale Pain at Rest

  at baseline (holding area), post anesthesia care unit (PACU) (hour 0), hour 6, 12, and 24 hours after surgery

• Pain Scores With Physical Therapy

  on post-operative physical therapy day 0, 1, and 2

• Quality of Recovery

  at baseline (holding area), 24 and 72 hours after surgery

• Opioid Related Side Effects

  at 24 hours after surgery

• Blinding Assessment

  at 72 hours after surgery

Study Arms (2)

ESPB with Bupivacaine and Dexamethasone

ACTIVE COMPARATOR

23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight.

Drug: Bupivacaine; Drug: Dexamethasone

ESPB with saline placebo

PLACEBO COMPARATOR

23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight.

Other: Saline

Interventions

Bupivacaine DRUG

Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures.

Also known as: Marcaine

ESPB with Bupivacaine and Dexamethasone

Dexamethasone DRUG

Dexamethasone is a corticosteroid that reduces inflammation.

Also known as: Decadron

ESPB with Bupivacaine and Dexamethasone

Saline OTHER

Saline is a mixture of NaCl and water that can be used as a placebo.

Also known as: sodium chloride

ESPB with saline placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Planned primary complex spine surgery: \>2 level- lumbar and/or thoraco-lumbar spine fusion with or without decompression
• Planned stand-alone posterior surgical approach
• Able to follow study protocol
• Able to communicate in English (outcome questionnaires validated in English)

You may not qualify if:

• Age \<18 or \>80
• Revision surgery
• BMI \> 35
• planned prolonged intubation/intubation overnight on night of surgery
• Unable to communicate in English
• History of chronic pain condition requiring gabapentin/pregabalin/antidepressant medication longer than 3 months
• Opioid tolerance (\>60 OME daily for \>2 weeks)
• Allergy, intolerance or contraindication to any protocol component/study medication/technique
• Patient refusal of regional analgesia (ESPB)

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Dexamethasone; Calcium Dobesilate; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Justas Lauzadis
• Organization: Hospital for Special Surgery

lauzadisj@hss.edu

212-774-2946

Study Officials

• Ellen Soffin, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 7, 2019
• Study Start: November 19, 2019
• Primary Completion: June 18, 2022
• Study Completion: June 18, 2022
• Last Updated: December 27, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal.

Locations

US (1)