Preemptive Analgesia for Postlaminectomy

Laminectomy Clinical Trial

Official title:

Intraoperative Perineural Injection of Lidocaine for Postlaminectomy Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656526
• Other study ID #: 012
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2008
• Last updated: April 10, 2008
• Start date: September 2007
• Est. completion date: December 2007

Study information

• Verified date: April 2008
• Source: Harran University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of HealthTurkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Laminectomy

Intervention

Drug:
• Lidocaine, perineural injection, intraoperatively
0.5 cc lidocaine, one single injection over the dorsal root.
• Lidocaine
0.5 cc %2 lidocaine,single injection

Locations

Country	Name	City	State
Turkey	harran University Education, Research and application hospital	Sanliurfa

Sponsors (1)

Lead Sponsor	Collaborator
Harran University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In the laminectomy operation, right after the exposure of the dorsal root , an injection of lidocaine attenuates postoperative pain.		postoperative 24 hours	No