Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain

NCT ID: NCT02293525

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2016-01-31

Brief Summary

The purpose of this study is to evaluate the clinical performance of the ReLeaf infusion catheter & wound drain in patients following lumbar spinal fusion surgery. One half of the patients will receive continuous local analgesic fusion during the post-operative period while the other half will received continuous local saline.

Detailed Description

Posterior lumbar spinal fusion is commonly used in the management of a wide array of spinal disorders ranging from instability to degenerative disc disease. However, severe postoperative pain is a significant adverse outcome in patients who have undergone a lumbar spinal fusion procedure. This pain may delay mobilization and decrease compliance with physical, occupational, or pulmonary physiotherapy.

Pain symptoms may worsen with activity and ambulation due to reflex spasms of the paraspinal muscles elicited by pain from the wound. A local anesthetic agent administered immediately after surgery into the tissue surrounding the wound addresses the pain source for less than four hours. Therefore, it is reasonable to consider continuous local anesthetic infusion, which may limit local pain mediators for a longer duration.

Continuous local anesthetic infusion into the paraspinal musculature with the ReLeaf catheter has the potential to reduce pain, narcotic demand & usage, and accelerate the rate of recovery in lumbar spinal fusion patients.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Ropivacaine

Continuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours)

Group Type: ACTIVE_COMPARATOR

ReLeaf catheter

Intervention Type: DEVICE

Continuous infusion rate 10ml/hr (5ml/side)

Ropivacaine

Intervention Type: DRUG

Morphine

Intervention Type: DRUG

Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg

Oxycodone

Intervention Type: DRUG

10mg every 4-6 hours

Saline

Continuous saline infusion until catheter removal (typically 36 hours)

Group Type: PLACEBO_COMPARATOR

ReLeaf catheter

Intervention Type: DEVICE

Continuous infusion rate 10ml/hr (5ml/side)

Saline

Intervention Type: DRUG

Morphine

Intervention Type: DRUG

Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg

Oxycodone

Intervention Type: DRUG

10mg every 4-6 hours

Interventions

ReLeaf catheter

Continuous infusion rate 10ml/hr (5ml/side)

Intervention Type: DEVICE

Ropivacaine

Intervention Type: DRUG

Saline

Intervention Type: DRUG

Morphine

Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg

Intervention Type: DRUG

Oxycodone

10mg every 4-6 hours

Intervention Type: DRUG

Other Intervention Names

Naropin; Oxycontin, Roxicodone, Oxecta

Eligibility Criteria

Inclusion Criteria

• Skeletally mature
• Diagnosis of lumbar spine disease requiring an open, midline, instrumented posterolateral fusion with or without interbody support at one or two vertebral levels and laminectomy or laminotomy
• Physically and mentally willing to comply with the study requirements
• Signed the study informed consent

Exclusion Criteria

• Lumbar spine disease requiring more than two levels of instrumentation
• Any previous operative lumbar procedure, except discectomy or hemi-laminotomy performed a minimum of 2 years prior to current study surgery
• Patients requiring iliac crest bone graft for the procedure
• Intra-operative durotomy
• Any duration of pre-operative morphine or morphine equivalent use exceeding 30 mg of morphine equivalents per day for longer than 3 months
• Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse)
• Diagnosed with Severe Depression and on treatment
• Active infection at the operative level or a symptomatic infection
• Diagnosed systemic disease that would affect the subject's welfare or overall outcome of the research study (i.e. Paget's disease, renal osteodystrophy, Lupus etc)
• Is pregnant or breast feeding
• Has any active malignancy or spinal arthrodesis being performed for a tumor decompression
• Has a known allergy to local analgesics
• Pending litigation related to back pain or injury or Worker's Compensation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vital 5, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Yukawa Y, Kato F, Ito K, Terashima T, Horie Y. A prospective randomized study of preemptive analgesia for postoperative pain in the patients undergoing posterior lumbar interbody fusion: continuous subcutaneous morphine, continuous epidural morphine, and diclofenac sodium. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2357-61. doi: 10.1097/01.brs.0000184377.31427.fa.

Reference Type: BACKGROUND

PMID: 16261108 (View on PubMed)

Gottschalk A, Freitag M, Tank S, Burmeister MA, Kreil S, Kothe R, Hansen-Algenstedt N, Weisner L, Staude HJ, Standl T. Quality of postoperative pain using an intraoperatively placed epidural catheter after major lumbar spinal surgery. Anesthesiology. 2004 Jul;101(1):175-80. doi: 10.1097/00000542-200407000-00027.

Reference Type: BACKGROUND

PMID: 15220788 (View on PubMed)

Bianconi M, Ferraro L, Ricci R, Zanoli G, Antonelli T, Giulia B, Guberti A, Massari L. The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. Anesth Analg. 2004 Jan;98(1):166-172. doi: 10.1213/01.ANE.0000093310.47375.44.

Reference Type: BACKGROUND

PMID: 14693613 (View on PubMed)

Elder JB, Hoh DJ, Wang MY. Postoperative continuous paravertebral anesthetic infusion for pain control in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2008 Jan 15;33(2):210-8. doi: 10.1097/BRS.0b013e318160447a.

Reference Type: BACKGROUND

PMID: 18197109 (View on PubMed)

Other Identifiers

CLI-001-0201

Identifier Type: -

Identifier Source: org_study_id