Preemptive Analgesia for Postlaminectomy

This study has been completed.
Sponsor:
Information provided by:
Harran University
ClinicalTrials.gov Identifier:
NCT00656526
First received: April 7, 2008
Last updated: April 10, 2008
Last verified: April 2008

April 7, 2008
April 10, 2008
September 2007
November 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00656526 on ClinicalTrials.gov Archive Site
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Preemptive Analgesia for Postlaminectomy
Intraoperative Perineural Injection of Lidocaine for Postlaminectomy Pain

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Laminectomy
  • 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
  • Placebo Comparator: A01L
    Interventions:
    • Drug: Lidocaine, perineural injection, intraoperatively
    • Drug: Lidocaine
  • No Intervention: B01C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00656526
012
No
Assistant Professor Cengiz Mordeniz, Harran University
Harran University
Not Provided
Study Chair: cengiz Mordeniz, MD, Ass Prof Harran University
Harran University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP