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

NeuroTherapia, Inc.

Status: Withdrawn

Conditions: Lumbar Laminectomy

Treatments: Drug: bupivacaine; Other: saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01847339

13-183

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

bupivacaine soaked sponges

Experimental group

Description:

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

Treatment:

Drug: bupivacaine

saline soaked sponges

Placebo Comparator group

Description:

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.

Treatment:

Other: saline solution