Preemptive Analgesia for Postlaminectomy - Full Text View

Sponsor:	Harran University
Information provided by:	Harran University
ClinicalTrials.gov Identifier:	NCT00656526

Purpose

To relieve post laminectomy pain, we have tried intraoperative perineural injection of lidocaine right after the exposure in expecting that this would be preemptive analgesia by blocking the nerve transmission so that postoperative pain starts later and lighter.

Condition	Intervention	Phase
Laminectomy	Drug: Lidocaine, perineural injection, intraoperatively Drug: Lidocaine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Intraoperative Perineural Injection of Lidocaine for Postlaminectomy Pain

Resource links provided by NLM:

Drug Information available for: Lidocaine

U.S. FDA Resources

Further study details as provided by Harran University:

Primary Outcome Measures:

In the laminectomy operation, right after the exposure of the dorsal root , an injection of lidocaine attenuates postoperative pain. [ Time Frame: postoperative 24 hours ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	September 2007
Study Completion Date:	December 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: A01L	Drug: Lidocaine, perineural injection, intraoperatively 0.5 cc lidocaine, one single injection over the dorsal root. Other Name: lidocaine Drug: Lidocaine 0.5 cc %2 lidocaine,single injection
No Intervention: B01C

Detailed Description:

A randomized double-blind 40 patients aged 18-50 of ASA I and II undergoing laminectomy were included in the study. All the patients were followed for their heart rate, arterial pressure , respiratory rate, oxygen saturation, end tidal CO2 and postoperative VAS scores.

All the patients were premedicated with midazolam 0.1 mg/kg intramuscularly 40 minutes prior to surgery. The induction was made 2 mg/kg propofol, 1 ug/kg remifentanyl, 0.5mg/kg rocuronium. After the orotracheal intubation anesthesia was maintained with isoflurane (%0.5-2.0) and 0.1 mg/kg rocuronium.Just before the exposure of dorsal root, 0.5 cc %2 lidocaine was injected on the dorsal root.The patients postoperative analgesic period, VAS scores and additional analgesic need was recorded. For the postoperative analgesia tramadol 1 mg/kg tramadol was used.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

laminectomy
18-50 age
ASA 1-2
both sex

Exclusion Criteria:

under 18 or older than 50
any disease other than back pain\
ASA 3-4

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656526

Locations

Turkey
harran University Education, Research and application hospital
Sanliurfa, Turkey, 63000

Sponsors and Collaborators

Harran University

Investigators

Study Chair:

cengiz Mordeniz, MD, Ass Prof

Harran University

More Information

No publications provided

Responsible Party:	Assistant Professor Cengiz Mordeniz, Harran University
ClinicalTrials.gov Identifier:	NCT00656526 History of Changes
Other Study ID Numbers:	012
Study First Received:	April 7, 2008
Last Updated:	April 10, 2008
Health Authority:	Turkey: Ministry of Health; Turkey: Ethics Committee

Keywords provided by Harran University:

analgesia, postlaminectomy , lidocaine, dorsal root

Additional relevant MeSH terms:

Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012