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

NCT01847339 | Withdrawn

• 1 other identifier: 13-183
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• reported post operative pain

  We will test the hypothesis, that the bupivacaine-soaked sponge reduces postoperative pain or reduces opioid consumption in patients undergoing spinal surgery.

  Day 1

• recorded opioid consumption

  We will test the hypothesis, that the bupivacaine-soaked sponge reduces postoperative pain or reduces opioid consumption in patients undergoing spinal surgery.

  Day 1

Secondary Outcomes (2)

• reported pain

  Day 1

• reported side effects

  Day 1

Study Arms (2)

bupivacaine soaked sponges

EXPERIMENTAL

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

saline soaked sponges

PLACEBO COMPARATOR

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

Interventions

bupivacaine DRUG

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.

bupivacaine soaked sponges

saline solution OTHER

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

saline soaked sponges

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Bupivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Farhad Firoozbakhsh, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 6, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 12, 2015
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

US (1)