Pain on Injection of Propofol,Lidocaine, Alkalinized LidocainePhase 4NCT01773044
Pain on Injection of Propofol: a Comparison of Lidocaine and Alkalinized Lidocaine
A Phase 4 study testing alkalinized lidocaine and Lidocaine in people with Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain. Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II, scheduled to undergo elective surgery, were randomly assigned… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine
- What is being tested?
- alkalinized lidocaine and Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2012to Nov 2012
- Phase
- Phase 4
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergoing elective surgery
Who cannot join
- allergy to the study drug
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu university medicine faculty
Malatya, 44280
About this study
Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain.
Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II, scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each. Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol 30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.
- Being tested
- alkalinized lidocaine, Lidocaine, Placebo (for alcalinized lidocaine)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alkalinized lidocaineDrug
recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)
LidocaineDrug
0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF),
Placebo (for alcalinized lidocaine)Drug
| Study group | Role | What they receive |
|---|---|---|
| alkalinized lidocaine & lidocaine | Active comparator | Not described Receives: Drug: alkalinized lidocaine; Drug: Lidocaine |
| alkalinized lidocaine &Placebo | Active comparator | Not described Receives: Drug: alkalinized lidocaine; Drug: Placebo (for alcalinized lidocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on injection of propofol
Measured: 5 th minutes after propofol injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
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 Pain on Injection of Propofol,Lidocaine, Alkalinized LidocaineStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Özgül, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773044
- Sponsor's protocol ID
- ulkü_1
- Status last verified
- Jan 2013
- First submitted
- 20 Dec 2012
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Borazan H, Erdem TB, Kececioglu M, Otelcioglu S. Prevention of pain on injection of propofol: a comparison of lidocaine with different doses of paracetamol. Eur J Anaesthesiol. 2010 Mar;27(3):253-7. doi: 10.1097/EJA.0b013e328330eca2.
PubMed 19696679