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Preemptive Analgesia for Postlaminectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00656526
First Posted: April 11, 2008
Last Update Posted: April 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Harran University
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intraoperative Perineural Injection of Lidocaine for Postlaminectomy Pain

Resource links provided by NLM:


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 ]

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

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistant Professor Cengiz Mordeniz, Harran University
ClinicalTrials.gov Identifier: NCT00656526     History of Changes
Other Study ID Numbers: 012
First Submitted: April 7, 2008
First Posted: April 11, 2008
Last Update Posted: April 11, 2008
Last Verified: April 2008

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
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action