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
  Purpose

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.


Condition Intervention
Lumbar Laminectomy
Drug: bupivacaine
Other: saline solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: April 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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.
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847339

Contacts
Contact: Firoozbakhsh Farhad, MD 216-444-4000 firoozf@ccf.org
Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Farhad Firoozbakhsh, MD    216-444-4000    firoozf@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Farhad Firoozbakhsh, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01847339     History of Changes
Other Study ID Numbers: 13-183
Study First Received: May 2, 2013
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pharmaceutical Solutions
Bupivacaine
Gelatin Sponge, Absorbable
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on September 22, 2014