PainPhase 4NCT00864682
Preventing Propofol-associated Injection Pain
A Phase 4 study testing Saline, Lidocaine / propofol admixture and lidocaine pretreatment in people with Pain, run by Benaroya Research Institute at 1 site in United States.
Trial summary
Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics have been shown to attenuate this response in some patients. This randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Saline, Lidocaine / propofol admixture and lidocaine pretreatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- weight >40kg, <100kg
- ambulatory surgery
Who cannot join
- allergy to propofol or lidocaine
- taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)
Trial locations and contacts
1 site in 1 country.
United States1 site
Benaroya Research Institute
Seattle, Washington, 98101
About this study
Official title: Propofol Mixed With Lidocaine Versus Lidocaine Pretreatment With Tourniquet for Alleviation of Pain Associated With Propofol Injection
Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics have been shown to attenuate this response in some patients. This randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly into the vein, under tourniquet control, prior to injection of propofol. Both groups are expected to be superior to placebo.
- Conditions
- Pain
- Being tested
- Saline, Lidocaine / propofol admixture, lidocaine pretreatment
- Keywords
- propofol, lidocaine, injection pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
3.3 mL normal saline
Lidocaine / propofol admixtureDrug
lidocaine 50 mg plus propofol 50 mg intravenous (iv)
lidocaine pretreatmentDrug
lidocaine 50 mg iv under tourniquet-control
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline pretreatment, saline admixture Receives: Drug: Saline |
| Lidocaine pretreatment | Active comparator | Lidocaine pretreatment / saline-propofol admixture Receives: Drug: lidocaine pretreatment |
| Lidocaine-Propofol admixture | Active comparator | saline pretreatment / Lidocaine-propofol admixture Receives: Drug: Lidocaine / propofol admixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Pain Score
11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain
Measured: Immediately after injection of study drug. One time assessment.
Secondary outcomes (2)
Complete Alleviation of Injection Pain
Total subjects within the arm versus those subjects who had no pain with injection (VPS=0)
Measured: Immediately after injection of study drug. One time assessment
Satisfaction With Anesthetic Technique
Were you satisfied with the anesthetic technique? Yes/No
Measured: Prior to discharge. One time assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Neal, Benaroya Research Institute
- Investigators
- Joseph M Neal, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864682
- Sponsor's protocol ID
- 06091
- Status last verified
- Jan 2021
- First submitted
- 16 Mar 2009
- Last updated
- 27 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Walker BJ, Neal JM, Mulroy MF, Humsi JA, Bittner RC, McDonald SB. Lidocaine pretreatment with tourniquet versus lidocaine-propofol admixture for attenuating propofol injection pain: a randomized controlled trial. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):41-5. doi: 10.1097/AAP.0b013e31820306da.
PubMed 21455088
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Mixed With Lidocaine Versus Lidocaine Pretreatment With Tourniquet for Alleviation of Pain Associated With Propofol Injection
- ClinicalTrials.gov ID
- NCT00864682
- Acronym / sponsor ID
- 06091
- Conditions
- Pain
- Keywords
- propofol, lidocaine, injection pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Posted 3 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics have been shown to attenuate this response in some patients. This randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly into the vein, under tourniquet control, prior to injection of propofol. Both groups are expected to be superior to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SalineSaline pretreatment, saline admixture |
| Lidocaine pretreatment | Active comparator | Drug: lidocaine pretreatmentLidocaine pretreatment / saline-propofol admixture |
| Lidocaine-Propofol admixture | Active comparator | Drug: Lidocaine / propofol admixturesaline pretreatment / Lidocaine-propofol admixture |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- weight >40kg, <100kg
- ambulatory surgery
Key exclusion criteria (2 listed)
- allergy to propofol or lidocaine
- taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)
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 |
|---|---|---|
| Saline3.3 mL normal saline | Drug | Placebo |
| Lidocaine / propofol admixturelidocaine 50 mg plus propofol 50 mg intravenous (iv) | Drug | Lidocaine-Propofol admixture |
| lidocaine pretreatmentlidocaine 50 mg iv under tourniquet-control | Drug | Lidocaine pretreatment |
Primary outcome
Verbal Pain Score
Time frame: Immediately after injection of study drug. One time assessment.
11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain
2 secondary outcomes
Complete Alleviation of Injection Pain
Time frame: Immediately after injection of study drug. One time assessment
Satisfaction With Anesthetic Technique
Time frame: Prior to discharge. One time assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21455088Walker BJ, Neal JM, Mulroy MF, Humsi JA, Bittner RC, McDonald SB. Lidocaine pretreatment with tourniquet versus lidocaine-propofol admixture for attenuating propofol injection pain: a randomized controlled trial. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):41-5. doi: 10.1097/AAP.0b013e31820306da.
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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.
Joseph M Neal, MD principal investigator
Virginia Mason 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 Saline, Lidocaine / propofol admixture and lidocaine pretreatment in people with Pain, run by Benaroya Research Institute at 1 site in United States.
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 2 inclusion and 2 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 27 Jan 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Verbal Pain Score (time frame: Immediately after injection of study drug. One time assessment.). 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 NCT00864682, 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 27 Jan 2021.