Preemptive Analgesia for Postlaminectomy

April 10, 2008 updated by: Harran University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A01L
Drug: Lidocaine, perineural injection, intraoperatively
0.5 cc lidocaine, one single injection over the dorsal root.
Other Names:
  • lidocaine
Drug: Lidocaine
0.5 cc %2 lidocaine,single injection
No Intervention: B01C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In the laminectomy operation, right after the exposure of the dorsal root , an injection of lidocaine attenuates postoperative pain.
Time Frame: postoperative 24 hours
postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harran University

Investigators

  • Study Chair: cengiz Mordeniz, MD, Ass Prof, Harran University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

April 7, 2008

First Submitted That Met QC Criteria

April 10, 2008

First Posted (Estimate)

April 11, 2008

Study Record Updates

Last Update Posted (Estimate)

April 11, 2008

Last Update Submitted That Met QC Criteria

April 10, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012 (Other Identifier: Nahrain Medical Research Collective (NMRC))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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