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A Study of Epidural Bupivacain-soaked Absorbable Gelatin Sponge on Post-operative Pain in Lumbar Laminectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01847339
First received: May 2, 2013
Last updated: March 4, 2014
Last verified: March 2014

May 2, 2013
March 4, 2014
April 2013
September 2014   (final data collection date for primary outcome measure)
  • reported post operative pain [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    We will test the hypothesis, that the bupivacaine-soaked sponge reduces postoperative pain or reduces opioid consumption in patients undergoing spinal surgery.
  • recorded opioid consumption [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    We will test the hypothesis, that the bupivacaine-soaked sponge reduces postoperative pain or reduces opioid consumption in patients undergoing spinal surgery.
Same as current
Complete list of historical versions of study NCT01847339 on ClinicalTrials.gov Archive Site
  • reported pain [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Bupivacaine epidural sponge increases the time from the end of the operation until the patient requested supplementation of analgesic.
  • reported side effects [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    We will also evaluate side effects of this method of analgesia such as sedation, urinary retention, hypotension, respiratory depression, nausea, vomiting and extremity weakness.
Same as current
Not Provided
Not Provided
 
A Study of Epidural Bupivacain-soaked Absorbable Gelatin Sponge on Post-operative Pain in Lumbar Laminectomy
Not Provided

The effective relief of pain is of paramount importance to anyone treating patients undergoing surgery. Post-operative pain increases the possibility of post-surgical complications, raises the cost of medical care, and most importantly, interferes with recovery and return to normal activities of daily living. Therefore pain control is essential in the management of patients undergoing spinal surgery.Parenteral administration of narcotics has been the mainstay for postoperative pain relief in patients undergoing laminectomy and discectomy. Epidural and intrathecal opioids are also effective means of pain control in several major surgical interventions including spinal surgery. However, some of the side effects have limited their widespread use (eg, late-onset respiratory depression). Therefore, alternative measures of pain control including infiltration of paraspinal musculature with local anesthetics have been investigated with conflicting results. In situations such as laminectomies, where the epidural space is exposed as part of the surgical procedure, the application of absorbable gelatin sponge soaked in local anesthetics appears to be an alternative for providing postoperative analgesia. By investigating the probable analgesic effects of this method the investigators may relieve post laminectomy pain with minimal side effects and also costs.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Lumbar Laminectomy
  • Drug: bupivacaine
    In study group a 1 square centimeter piece of absorbable gelatin sponge will be soaked in the bupivacaine solution %0.25 and then will be placed by the surgeon in the epidural space before final closure.
  • Other: saline solution
    In study group a 1 square centimeter piece of absorbable gelatin sponge will be soaked in the saline solution and then will be placed by the surgeon in the epidural space before final closure
  • Experimental: bupivacaine soaked sponges
    Patients will be randomized using a reproducible set of computer-generated random numbers. In study group a 1 square centimeter piece of absorbable gelatin sponge will be soaked in the bupivacaine solution %0.25 and then will be placed by the surgeon in the epidural space before final closure
    Intervention: Drug: bupivacaine
  • Placebo Comparator: saline soaked sponges
    Patients will be randomized using a reproducible set of computer-generated random numbers. In study group a 1 square centimeter piece of absorbable gelatin sponge will be soaked in saline solution and then will be placed by the surgeon in the epidural space before final closure.
    Intervention: Other: saline solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA grade I or III
  • scheduled to undergo lumbar laminectomy

Exclusion Criteria:

  • Patients who are younger than 18 years of age
  • pregnant
  • spinal or lateral stenosis
  • previous intervertebral disc surgery at that level
  • patients with history of chronicity (symptoms >6 months duration) or coexisting medical conditions such as substance abuse or withdrawal, hyperthyroidism, anxiety disorder, affective disorder, hepatic or renal impairments
Both
18 Years to 80 Years
No
Contact: Firoozbakhsh Farhad, MD 216-444-4000 firoozf@ccf.org
Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org
United States
 
NCT01847339
13-183
No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Farhad Firoozbakhsh, MD The Cleveland Clinic
The Cleveland Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP