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

NCT01847339 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-01-09

No results posted yet for this study

Summary

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.

Conditions

  • Lumbar Laminectomy

Interventions

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

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Farhad Firoozbakhsh, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-02-28
Completion
2015-02-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847339 on ClinicalTrials.gov