LaminectomyPhase 4NCT00656526
Preemptive Analgesia for Postlaminectomy
A Phase 4 study testing Lidocaine, perineural injection, intraoperatively and Lidocaine in people with Laminectomy, run by Harran University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Laminectomy
- What is being tested?
- Lidocaine, perineural injection, intraoperatively and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2007to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- laminectomy
- 18-50 age
- ASA 1-2
- both sex
Who cannot join
- under 18 or older than 50
- any disease other than back pain\
- ASA 3-4
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
harran University Education, Research and application hospital
Sanliurfa, Şanlıurfa, 63000
About this study
Official title: 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.
Read the 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
- Being tested
- Lidocaine, perineural injection, intraoperatively, Lidocaine
- Keywords
- analgesia, postlaminectomy , lidocaine, dorsal root
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine, perineural injection, intraoperativelyDrug
Also called lidocaine
0.5 cc lidocaine, one single injection over the dorsal root.
LidocaineDrug
0.5 cc %2 lidocaine,single injection
| Study group | Role | What they receive |
|---|---|---|
| A01L | Placebo comparator | Not described Receives: Drug: Lidocaine, perineural injection, intraoperatively; Drug: Lidocaine |
| B01C | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
In the laminectomy operation, right after the exposure of the dorsal root , an injection of lidocaine attenuates postoperative pain.
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startSep 2007
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaminectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Investigators
- cengiz Mordeniz, MD, Ass Prof, Study chair, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656526
- Sponsor's protocol ID
- 012
- Status last verified
- Apr 2008
- First submitted
- 7 Apr 2008
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Perineural Injection of Lidocaine for Postlaminectomy Pain
- ClinicalTrials.gov ID
- NCT00656526
- Acronym / sponsor ID
- 012
- Conditions
- Laminectomy
- Keywords
- analgesia, postlaminectomy , lidocaine, dorsal root
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A01L | Placebo comparator | Drug: Lidocaine, perineural injection, intraoperatively, Drug: Lidocaine |
| B01C | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- laminectomy
- 18-50 age
- ASA 1-2
- both sex
Key exclusion criteria (3 listed)
- under 18 or older than 50
- any disease other than back pain\
- ASA 3-4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine, perineural injection, intraoperativelyAlso: lidocaine0.5 cc lidocaine, one single injection over the dorsal root. | Drug | A01L |
| Lidocaine0.5 cc %2 lidocaine,single injection | Drug | A01L |
Primary outcome
In the laminectomy operation, right after the exposure of the dorsal root , an injection of lidocaine attenuates postoperative pain.
Time frame: postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
cengiz Mordeniz, MD, Ass Prof study chair
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine, perineural injection, intraoperatively and Lidocaine in people with Laminectomy, run by Harran University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In the laminectomy operation, right after the exposure of the dorsal root , an injection of lidocaine attenuates postoperative pain. (time frame: postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2008; AzTrials last refreshed its copy on 28 Oct 2026.