Preemptive Analgesia for Postlaminectomy

NCT ID: NCT00656526

Last Updated: 2008-04-11

Basic Information

• 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

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

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

Laminectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

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

lidocaine

Eligibility Criteria

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

Harran University

OTHER

Sponsor Role: lead

Responsible Party

Harran University

Principal Investigators

cengiz Mordeniz, MD, Ass Prof

Role: STUDY_CHAIR

Harran University

Locations

harran University Education, Research and application hospital

Sanliurfa, Şanlıurfa, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

012

Identifier Type: -

Identifier Source: org_study_id