Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery

NCT03115151 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: STU 092016-061
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple different drugs and techniques to control pain after surgery), there is no consensus regarding which components of this multimodal therapy provide optimal analgesia. This prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion Surgery at Zale Lipshy University Hospital. The primary objective is to determine the comparative efficacy of epidural analgesia, as compared with intravenous (IV) patient-controlled analgesia (PCA), on post-operative analgesia.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Score (VAS)

  Postoperative Visual Analog Pain Score following lumbar fusion surgery. VAS on the scale 0 to 100 (0= no pain, 100= worst pain).

  VAS score at postoperative 24 hours

Study Arms (2)

Patient-Controlled Epidural Analgesia

EXPERIMENTAL

Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours

Drug: Bupivacaine; Drug: Fentanyl

Intravenous patient-controlled analgesia

SHAM COMPARATOR

Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone

Drug: Hydromorphone

Interventions

Bupivacaine DRUG

Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter

Also known as: Bupivacaine Hydrochloride

Patient-Controlled Epidural Analgesia

Hydromorphone DRUG

Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL).

Also known as: DILAUDID

Intravenous patient-controlled analgesia

Fentanyl DRUG

Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine.

Also known as: Opioid

Patient-Controlled Epidural Analgesia

Eligibility Criteria

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

You may qualify if:

• Adult subjects aged 18 years or older
• Scheduled for elective posterior lumbar spinal fusion surgery between 1 and 3 levels

You may not qualify if:

• Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
• Immunocompromised subject
• Coagulopathy
• Severe liver and renal dysfunction
• Preoperative neurological deficits
• The dura damage during surgery
• Inability to follow directions or comprehend the English language.
• Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.
• Prisoners.
• Patient refusal to provide informed consent.
• Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine) or opioid (fentanyl) allergy if patient assigned epidural analgesia.
• Hydromorphone allergy if patient assigned IV PCA

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9068, United States

Location

University Of Texas Southwestern Medical Center, Zale University Hospital

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Hydromorphone; Fentanyl; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Dr. Enas Kandil
• Organization: UT Southwestern Medical Center

Enas.Kandil@UTSouthwestern.edu

214/648-9374

Study Officials

• Enas Kandil, MD

  University of Texas Southwestern Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC PROFESSOR - Anesthesiology & Pain Mgmt

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 14, 2017
• Study Start: May 8, 2017
• Primary Completion: August 18, 2022
• Study Completion: April 4, 2023
• Last Updated: October 26, 2023
• Results First Posted: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)