Nose Deformities, AcquiredPhase 4NCT01827020
Effect of Ketamine Addition to Lidocaine in Rhinoplasty
A Phase 4 study testing Lidocaine 2 %, Ketamine plus Lidocaine and Saline in people with Nose Deformities, Acquired, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether subanesthetic ketamine addition to lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Nose Deformities, Acquired
- What is being tested?
- Lidocaine 2 %, Ketamine plus Lidocaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Mar 2013
- 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
- Patients scheduled for elective rhinoplasty operation under general anesthesia
- Patients with ASA (American Society of Anesthesiology) class I
- Patients between 18-50 years old
Who cannot join
- Age <18 and >50
- ASA > II
- Preexisting neurological or psychiatric illness
- Systemic diseases (diabetes mellitus, hypertension, coronary heart disease...)
- Having a history of chronic pain and receiving chronic analgesia therapy
- Having a history of drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ketamine Addition to Lidocaine for Postoperative Pain Management in Rhinoplasty
The purpose of this study is to determine whether subanesthetic ketamine addition to lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty.
Read the detailed description
In rhinoplasty operations local infiltration anesthesia uses for surgery insight and patient comfort. The investigators designed this study to prolonged the time of infiltration block and preventive analgesia. So, before operation, study drugs will infiltrate to the submucosa of intranasal cavity. Then, surgeon and patient satisfaction, postoperative analgesic demand, postoperative pain scores and side effects will determine.
- Conditions
- Nose Deformities, Acquired
- Being tested
- Lidocaine 2 %, Ketamine plus Lidocaine, Saline
- Medical subject headings
- Nose Deformities, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2 %Drug
Also called preincisional infiltration of lidocaine
12 mL lidocaine 2% 1mg/kg
Ketamine plus LidocaineDrug
Also called preincisional infiltration of ketamine plus lidocaine
ketamine 0.5 mg/kg + Lidocaine 2% 1 mg/kg in total volume of 12 mL
SalineDrug
Also called preincisional infiltration of saline
12 mL saline (0.9% isotonic solution)
| Study group | Role | What they receive |
|---|---|---|
| Group L (number of participants=30) | Active comparator | After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL lidocaine 2%, 1mg/kg into nasal cavity. Receives: Drug: Lidocaine 2 % |
| Group K (number of participants=30) | Active comparator | After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL ketamine 0.5 mg/kg plus lidocaine 2% 1 mg/kg of the intranasal cavity. Receives: Drug: Ketamine plus Lidocaine |
| Group S (number of participants=30) | Placebo comparator | After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of saline 12 mL into intranasal cavity. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores on the Visual Analogue Scale
Pain scores will examine with Visual analogue scale (VAS, 0-100) in the first 24 hours of postoperative period. The examination will repeated in different time period(5.min, 15.min, 30.min, 1 h, 2h,4.h, 6.h, 8.h, 16.h, 24.h). Patients that have VAS>40 will receive 1mg/kg tramadol.
Measured: 24 hours
Secondary outcomes (2)
Patient satisfaction
At the end of postoperative 24 h, the patient satisfaction will examine by a score as (1 poor, 2 middle, 3 good, 4 perfect)
Measured: 24 hour
Analgesic demand
At the first day of postoperative period, analgesic requirement will record. When Visual analogue scale > 40, intravenous 1 mg/kg tramadol bolus will give.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nose Deformities, AcquiredStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mukadder Sanli, Inonu University
- Investigators
- Mukadder Sanli, MD, Principal investigator, Turgut Ozal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827020
- Sponsor's protocol ID
- Mukadder
- Status last verified
- Apr 2013
- First submitted
- 28 Mar 2013
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Honarmand A, Safavi M, Karaky H. Preincisional administration of intravenous or subcutaneous infiltration of low-dose ketamine suppresses postoperative pain after appendectomy. J Pain Res. 2012;5:1-6. doi: 10.2147/JPR.S26476. Epub 2011 Dec 30.
PubMed 22328829
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketamine Addition to Lidocaine for Postoperative Pain Management in Rhinoplasty
- ClinicalTrials.gov ID
- NCT01827020
- Acronym / sponsor ID
- Mukadder
- Conditions
- Nose Deformities, Acquired
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Apr 2013 (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.
The purpose of this study is to determine whether subanesthetic ketamine addition to lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty.
Detailed description
In rhinoplasty operations local infiltration anesthesia uses for surgery insight and patient comfort. The investigators designed this study to prolonged the time of infiltration block and preventive analgesia. So, before operation, study drugs will infiltrate to the submucosa of intranasal cavity. Then, surgeon and patient satisfaction, postoperative analgesic demand, postoperative pain scores and side effects will determine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group L (number of participants=30) | Active comparator | Drug: Lidocaine 2 %After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL lidocaine 2%, 1mg/kg into nasal cavity. |
| Group K (number of participants=30) | Active comparator | Drug: Ketamine plus LidocaineAfter standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL ketamine 0.5 mg/kg plus lidocaine 2% 1 mg/kg of the intranasal cavity. |
| Group S (number of participants=30) | Placebo comparator | Drug: SalineAfter standard anesthesia induction and before surgery, patients will receive submucosal infiltration of saline 12 mL into intranasal cavity. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective rhinoplasty operation under general anesthesia
- Patients with ASA (American Society of Anesthesiology) class I
- Patients between 18-50 years old
Key exclusion criteria (6 listed)
- Age <18 and >50
- ASA > II
- Preexisting neurological or psychiatric illness
- Systemic diseases (diabetes mellitus, hypertension, coronary heart disease...)
- Having a history of chronic pain and receiving chronic analgesia therapy
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 2 %Also: preincisional infiltration of lidocaine12 mL lidocaine 2% 1mg/kg | Drug | Group L (number of participants=30) |
| Ketamine plus LidocaineAlso: preincisional infiltration of ketamine plus lidocaineketamine 0.5 mg/kg + Lidocaine 2% 1 mg/kg in total volume of 12 mL | Drug | Group K (number of participants=30) |
| SalineAlso: preincisional infiltration of saline12 mL saline (0.9% isotonic solution) | Drug | Group S (number of participants=30) |
Primary outcome
Postoperative pain scores on the Visual Analogue Scale
Time frame: 24 hours
Pain scores will examine with Visual analogue scale (VAS, 0-100) in the first 24 hours of postoperative period. The examination will repeated in different time period(5.min, 15.min, 30.min, 1 h, 2h,4.h, 6.h, 8.h, 16.h, 24.h). Patients that have VAS>40 will receive 1mg/kg tramadol.
2 secondary outcomes
Patient satisfaction
Time frame: 24 hour
Analgesic demand
Time frame: 24 hour
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 9 Apr 2013.
- Results publication: PubMed 22328829Honarmand A, Safavi M, Karaky H. Preincisional administration of intravenous or subcutaneous infiltration of low-dose ketamine suppresses postoperative pain after appendectomy. J Pain Res. 2012;5:1-6. doi: 10.2147/JPR.S26476. Epub 2011 Dec 30.
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.
Mukadder Sanli, MD principal investigator
Turgut Ozal Medical Center
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 2 %, Ketamine plus Lidocaine and Saline in people with Nose Deformities, Acquired, run by Inonu 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 3 inclusion and 6 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 9 Apr 2013. 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?
Postoperative pain scores on the Visual Analogue Scale (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01827020, which also lists 1 linked publication.
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 9 Apr 2013.