NCT00656526

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
Last Updated

April 11, 2008

Status Verified

April 1, 2008

Enrollment Period

2 months

First QC Date

April 7, 2008

Last Update Submit

April 10, 2008

Conditions

Laminectomy

Keywords

analgesia, postlaminectomy , lidocaine, dorsal root

Outcome Measures

Primary Outcomes (1)

  • In the laminectomy operation, right after the exposure of the dorsal root , an injection of lidocaine attenuates postoperative pain.

    postoperative 24 hours

Study Arms (2)

A01L

PLACEBO COMPARATOR
Drug: Lidocaine, perineural injection, intraoperativelyDrug: Lidocaine

B01C

NO INTERVENTION

Interventions

Lidocaine, perineural injection, intraoperativelyDRUG

0.5 cc lidocaine, one single injection over the dorsal root.

Also known as: lidocaine
A01L
LidocaineDRUG

0.5 cc %2 lidocaine,single injection

A01L

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • laminectomy
  • age
  • ASA 1-2
  • both sex

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

harran University Education, Research and application hospital

Sanliurfa, Şanlıurfa, 63000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • cengiz Mordeniz, MD, Ass Prof

    Harran University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 11, 2008

Study Start

September 1, 2007

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

April 11, 2008

Record last verified: 2008-04

Locations

TU(1)