Preemptive Analgesia for Postlaminectomy

NCT ID: NCT00656526

Last Updated: 2008-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Laminectomy

Keywords

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analgesia, postlaminectomy , lidocaine, dorsal root

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A01L

Group Type PLACEBO_COMPARATOR

Lidocaine, perineural injection, intraoperatively

Intervention Type DRUG

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

Lidocaine

Intervention Type DRUG

0.5 cc %2 lidocaine,single injection

B01C

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lidocaine, perineural injection, intraoperatively

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

Intervention Type DRUG

Lidocaine

0.5 cc %2 lidocaine,single injection

Intervention Type DRUG

Other Intervention Names

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lidocaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harran University

OTHER

Sponsor Role lead

Responsible Party

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Harran University

Principal Investigators

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cengiz Mordeniz, MD, Ass Prof

Role: STUDY_CHAIR

Harran University

Locations

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harran University Education, Research and application hospital

Sanliurfa, Şanlıurfa, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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012

Identifier Type: -

Identifier Source: org_study_id