Erector Spinae Block for Spine Surgery

NCT05417113 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: STUDY-22-00168
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery. Given previous studies found long term benefits from liposomal bupivacaine, the hypothesis is that patients will have decreased opioid usage and improved pain scores when compared to a standard ESP block with plain 0.25% bupivacaine.

Conditions

Lumbar Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Postoperative Opioid Consumption During First 72 Hours

  The amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours

  12 hours, 24 hours, 48 hours, 72 hours

Secondary Outcomes (5)

• Change in Pain Score

  up to 12 weeks

• Quality of Recovery (QOR 15)

  72 hours

• Number of Participants With Postoperative Nausea/Vomiting (PONV)

  in PACU (4 hours)

• Time to Ambulation

  average 26-27 hours

• Hospital Length of Stay

  average 72 hours

Study Arms (2)

Bupivacaine only

ACTIVE COMPARATOR

bupivacaine 0.25% in ESP blocks

Drug: Bupivacaine

Liposomal Bupivacaine and Bupivacaine

EXPERIMENTAL

liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks

Drug: Liposomal bupivacaine; Drug: Bupivacaine

Interventions

Liposomal bupivacaine DRUG

liposomal bupivacaine

Liposomal Bupivacaine and Bupivacaine

Bupivacaine DRUG

bupivacaine 0.25% in ESP blocks

Bupivacaine only; Liposomal Bupivacaine and Bupivacaine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged greater than or equal to 18 years old and less than or equal to 85 years old.
• Patients who are scheduled to undergo lumbar spinal surgery (1-2 level) and willing and able to provide informed consent.

You may not qualify if:

• Patients with a history of chronic opioid use for \> 3 months including but not limited to fentanyl, morphine, oxycodone, methadone.
• Patients with known allergy or intolerance to any drug used in the study including local anesthetics and total intravenous anesthesia medications.
• Patients with a history of alcohol or drug abuse.
• Patients with a history of intolerance of nonsteroidal anti-inflammatory drugs.-Patients with hepatic insufficiency.
• Patients with renal insufficiency.
• Patients who are pregnant.
• Patients with American Society of Anesthesiologists physical status of 4 or greater.
• Patients on immunosuppressive therapy. Pregnant patients.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Radiculopathy

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Very limited enrollment due to volume of relevant surgeries and patient eligibility. Opioid consumption confounded by nonuniform usage of PCAs post-operatively.

Results Point of Contact

• Title: Dr. Christina Jeng
• Organization: Icahn School of Medicine at Mount Sinai

christina.jeng@Mountsinai.org

212-241-4743

Study Officials

• Christina Jeng, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: 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: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: August 31, 2022
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)