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

NCT ID: NCT03115151

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-08
• Study Completion Date: 2023-04-04

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.

Detailed Description

Study Design: Prospective study of 58 subjects undergoing elective Lumbar Spinal Fusion (1-3 levels- posterior approach) at UTSW Zale Lipshy University Hospital with:

1. Continuous Lumbar Epidural Analgesia (Patient-Controlled Epidural Analgesia- PCEA groups)

2. Intravenous Patient-Controlled Analgesia (IV PCA)

Study Interventions - The intervention to be evaluated in this study is epidural analgesia using an infusion of 0.0625% bupivacaine plus fentanyl 2mcg/ml. The epidural infusion will be continued until it is appropriate to transition the patient to a regimen of oral pain medications. Duration of epidural catheter will be 72 hours a postoperatively.

For subjects in the IV PCA group, the intervention will include post-operative IV PCA with Hydromorphone.

Epidural catheters will be placed by the spine surgeon under direct visualization intra-operatively prior to closing the surgical incision. Intra-operative epidural catheter placement by the spine surgeon will typically be done at the upper end of the dural exposure/laminectomy.

Epidurals will be assessed for efficacy/function in the recovery room post-operatively by the APS, and then daily on the floor post-operatively (unless contacted by the floor nurse regarding specific concerns).

Visual analog pain scale (VAS) will be used to evaluate degree of pain at 3, 24, 48, and 72 hours after surgery.

Additionally, both the IV PCA and the epidural PCEA groups may be given additional "rescue" pain medications as needed in the recovery room, and these may be continued through the post-operative period on the floor.

Total study duration is approximately 50 days, which starts from operating room admission for spinal fusion surgery to the first follow-up visit after discharge.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient-Controlled Epidural Analgesia

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

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

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

Fentanyl

Intervention Type: DRUG

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

Intravenous patient-controlled analgesia

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

Group Type: SHAM_COMPARATOR

Hydromorphone

Intervention Type: DRUG

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

Interventions

Bupivacaine

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

Intervention Type: DRUG

Hydromorphone

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

Intervention Type: DRUG

Fentanyl

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

Intervention Type: DRUG

Other Intervention Names

Bupivacaine Hydrochloride; DILAUDID; Opioid

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Enas Kandil

ASSOC PROFESSOR - Anesthesiology & Pain Mgmt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enas Kandil, MD

Role: STUDY_CHAIR

UT Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University Of Texas Southwestern Medical Center, Zale University Hospital

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU 092016-061

Identifier Type: -

Identifier Source: org_study_id