Injections, IntravenousPhase 4NCT03057704
Comparison of Two Techniques of IV Lidocaine on Propofol Injection Pain
A Phase 4 study testing Lidocaine injection flushed and Lidocaine injection tourniquet in people with Injections, Intravenous, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Intravenous lidocaine is commonly given through an intravenous (IV) line prior to injection of propofol to reduce the amount of pain during propofol injection. The investigators want to study if giving the lidocaine through the IV while the forearm on the same limb has a tourniquet applied to it to prevent "washing… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Injections, Intravenous
- What is being tested?
- Lidocaine injection flushed and Lidocaine injection tourniquet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2016to 20 Jan 2017
- 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
- Any subject at North Carolina Baptist Hospital scheduled for a procedure in which they will receive propofol for sedation or anesthesia and will not be receiving any other medications prior to the propofol injection.
- Cases must be schedule to have a duration less than 60 minutes.
Who cannot join
- Subjects are excluded if they cannot verbalize a rating of pain
- Subjects are excluded if they require intravenous medications prior to the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina Baptist Hospital
Winston-Salem, North Carolina, 27612
About this study
Official title: Comparison of Two Techniques of Administering IV Lidocaine in Reducing Propofol Injection Pain
Intravenous lidocaine is commonly given through an intravenous (IV) line prior to injection of propofol to reduce the amount of pain during propofol injection. The investigators want to study if giving the lidocaine through the IV while the forearm on the same limb has a tourniquet applied to it to prevent "washing out" of the lidocaine prior to propofol injection helps reduce propofol injection pain.
Read the detailed description
The investigators expect that tourniquet lidocaine is superior to straight non-tourniquet lidocaine in reducing propofol injection pain. The investigators also wanted to determine the association of tourniquet duration on reduction of pain with propofol administration. Small studies indicate that 60 seconds of tourniquet lidocaine is superior to 30 seconds or less of tourniquet duration or mixed lidocaine/propofol for injection. The investigators suspect many clinicians do not use the 60-second tourniquet technique due to the extra time involved but hypothesize that a more practical application by applying the tourniquet as soon as the patient is positioned on the operating table will not only be more widely adopted by clinicians as it does not cause delay but also provide the necessary amount of time for benefit from the tourniquet. The investigators also wanted to record the time from tourniquet application to start of propofol administration, which the investigators predict would be at least 60 seconds to see if there is a correlation between duration of venous stasis of IV lidocaine and pain benefit.
Methods and Measures
Design This was conducted as a randomized controlled trial of two methods of administering lidocaine prior to propofol injection.
Setting The study setting was located within North Carolina Baptist Health, an academic medical center, in the Endoscopy Suite or Outpatient Surgery Center where subjects were scheduled to receive propofol as part of their sedation or anesthetic.
Sample Size The investigators estimated that 25 subjects in each of the two groups was required to test the hypothesis based on prior studies.
Interventions and Interactions
The investigators used two groups:
- Group 1: 50mg of 2% lidocaine given just prior to the propofol dose through the IV line.
- Group 2: 50mg of 2% lidocaine given IV with venous occlusion applied when the patient is positioned on the operating room table and timed until the onset of propofol administration. The tourniquet the investigators used was a Quick Release tourniquet applied to the forearm 10cm distal to the elbow joint in the tourniquet group. Venous stasis was confirmed with cessation of flow from hanging IV fluid.
For both groups, no premedication was given, which is the normal practice for these procedures. Study procedures involved placing a 20 gauge intravenous (IV) catheter in a vein distal to the mid forearm. Venous occlusion was achieved by either a latex free tourniquet or McKesson Quick Release tourniquet applied to the forearm 10cm distal to the elbow joint. Tourniquet pressure was somewhat variable but sufficient to cause venous stasis as confirmed by no flow of hanging IV fluid. Injections were delivered at roughly 1 ml/sec.
Schedule of events in the study (all performed by 1 of the 2 investigators:
- Day of procedure: holding area
- Consent subject for study participation
- Randomly assign patient to one of two groups
- Day of procedure: procedure area -Accompany subject to the operating or procedure room, perform protocol from the group to which the subjects were assigned, while noting outcome measures such as self-described discomfort and observer graded discomfort
- Day of procedure: recovery area -Revisit subject in recovery 30 minutes after their procedure to determine post-procedure recall of discomfort
- Post-study period
- Analyze data
Analytical Plan The investigators will analyze results initially using descriptive statistics. Comparison between groups was done using chi square tests for proportions, and t-tests or ANOVA procedures for continuous variables. Regression analysis was performed to identify independent outcome predictors. Other inferential statistical analysis was conducted as appropriate.
Informed Consent One of the two investigators obtained signed informed consent from each subject. This was performed in the holding room prior to the procedure since most subjects had their pre-procedure examination performed in the holding room and were not seen prior to the day of their procedure.
- Conditions
- Injections, Intravenous
- Being tested
- Lidocaine injection flushed, Lidocaine injection tourniquet
- Keywords
- Propofol, lidocaine, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine injection flushedDrug
Also called Xylocaine
The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.
Lidocaine injection tourniquetDrug
Also called Xylocaine, Tourniquet
Intravenous lidocaine: tourniquet
| Study group | Role | What they receive |
|---|---|---|
| Intravenous lidocaine: flushed | Active comparator | Lidocaine injection flushed Receives: Drug: Lidocaine injection flushed |
| Intravenous lidocaine: tourniquet | Experimental | Lidocaine injection tourniquet Receives: Drug: Lidocaine injection tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Expression of Pain
Patient's verbal rating of pain during injection (see link to study protocol)
We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question:
How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale:
- None (0)
- Mild (1)
- Moderate (2)
- Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).
Measured: During injection at beginning of study; lasts 10 seconds one time only
Secondary outcomes (2)
Subject's Recall of Injection Discomfort
Investigator asks patient if they recall discomfort during injection after the procedure.
Patient's verbal rating and recall of pain during injection.
We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question:
How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale:
- None (0)
- Mild (1)
- Moderate (2)
- Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).
Measured: This occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time only
Investigators Rating of Patient Discomfort
Investigator rates patient's nonverbal display of discomfort.
Investigator Assessments:
Induction Discomfort Scale (during injection and within 5 seconds after injection)
- No change in patient behavior (0)
- Grimace (1)
- IV forearm withdrawal (2)
- Moaning (3)
- Verbal statement of discomfort ("it hurts", etc.) (4) 0 indicates desired outcome of no pain and 4 indicates worst IV pain experienced.
Measured: During injection at beginning of study period; lasts 10 seconds one time only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start5 Dec 2016
- Primary completion20 Jan 2017
- Study completion20 Jan 2017
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.
- Other trials for Injections, IntravenousStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Model description
- A randomized, controlled trial of two methods of administering lidocaine prior to propofol injection
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy N Harwood, MD, Principal investigator, Wake Forest University Health SciencesPatrick Grace, MD, Study director, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057704
- Sponsor's protocol ID
- IRB00040756
- Status last verified
- Aug 2018
- First submitted
- 15 Feb 2017
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Techniques of Administering IV Lidocaine in Reducing Propofol Injection Pain
- ClinicalTrials.gov ID
- NCT03057704
- Acronym / sponsor ID
- IRB00040756
- Conditions
- Injections, Intravenous
- Keywords
- Propofol, lidocaine, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 20 Jan 2017 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Posted 13 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intravenous lidocaine is commonly given through an intravenous (IV) line prior to injection of propofol to reduce the amount of pain during propofol injection. The investigators want to study if giving the lidocaine through the IV while the forearm on the same limb has a tourniquet applied to it to prevent "washing out" of the lidocaine prior to propofol injection helps reduce propofol injection pain.
Detailed description
The investigators expect that tourniquet lidocaine is superior to straight non-tourniquet lidocaine in reducing propofol injection pain. The investigators also wanted to determine the association of tourniquet duration on reduction of pain with propofol administration. Small studies indicate that 60 seconds of tourniquet lidocaine is superior to 30 seconds or less of tourniquet duration or mixed lidocaine/propofol for injection. The investigators suspect many clinicians do not use the 60-second tourniquet technique due to the extra time involved but hypothesize that a more practical application by applying the tourniquet as soon as the patient is positioned on the operating table will not only be more widely adopted by clinicians as it does not cause delay but also provide the necessary amount of time for benefit from the tourniquet. The investigators also wanted to record the time from tourniquet application to start of propofol administration, which the investigators predict would be at least 60 seconds to see if there is a correlation between duration of venous stasis of IV lidocaine and pain benefit.
Methods and Measures
Design This was conducted as a randomized controlled trial of two methods of administering lidocaine prior to propofol injection.
Setting The study setting was located within North Carolina Baptist Health, an academic medical center, in the Endoscopy Suite or Outpatient Surgery Center where subjects were scheduled to receive propofol as part of their sedation or anesthetic.
Sample Size The investigators estimated that 25 subjects in each of the two groups was required to test the hypothesis based on prior studies.
Interventions and Interactions
The investigators used two groups:
- Group 1: 50mg of 2% lidocaine given just prior to the propofol dose through the IV line.
- Group 2: 50mg of 2% lidocaine given IV with venous occlusion applied when the patient is positioned on the operating room table and timed until the onset of propofol administration. The tourniquet the investigators used was a Quick Release tourniquet applied to the forearm 10cm distal to the elbow joint in the tourniquet group. Venous stasis was confirmed with cessation of flow from hanging IV fluid.
For both groups, no premedication was given, which is the normal practice for these procedures. Study procedures involved placing a 20 gauge intravenous (IV) catheter in a vein distal to the mid forearm. Venous occlusion was achieved by either a latex free tourniquet or McKesson Quick Release tourniquet applied to the forearm 10cm distal to the elbow joint. Tourniquet pressure was somewhat variable but sufficient to cause venous stasis as confirmed by no flow of hanging IV fluid. Injections were delivered at roughly 1 ml/sec.
Schedule of events in the study (all performed by 1 of the 2 investigators:
- Day of procedure: holding area
- Consent subject for study participation
- Randomly assign patient to one of two groups
- Day of procedure: procedure area -Accompany subject to the operating or procedure room, perform protocol from the group to which the subjects were assigned, while noting outcome measures such as self-described discomfort and observer graded discomfort
- Day of procedure: recovery area -Revisit subject in recovery 30 minutes after their procedure to determine post-procedure recall of discomfort
- Post-study period
- Analyze data
Analytical Plan The investigators will analyze results initially using descriptive statistics. Comparison between groups was done using chi square tests for proportions, and t-tests or ANOVA procedures for continuous variables. Regression analysis was performed to identify independent outcome predictors. Other inferential statistical analysis was conducted as appropriate.
Informed Consent One of the two investigators obtained signed informed consent from each subject. This was performed in the holding room prior to the procedure since most subjects had their pre-procedure examination performed in the holding room and were not seen prior to the day of their procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized, controlled trial of two methods of administering lidocaine prior to propofol injection
| Arm | Type | Receives |
|---|---|---|
| Intravenous lidocaine: flushed | Active comparator | Drug: Lidocaine injection flushedLidocaine injection flushed |
| Intravenous lidocaine: tourniquet | Experimental | Drug: Lidocaine injection tourniquetLidocaine injection tourniquet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any subject at North Carolina Baptist Hospital scheduled for a procedure in which they will receive propofol for sedation or anesthesia and will not be receiving any other medications prior to the propofol injection.
- Cases must be schedule to have a duration less than 60 minutes.
Key exclusion criteria (2 listed)
- Subjects are excluded if they cannot verbalize a rating of pain
- Subjects are excluded if they require intravenous medications prior to the study period
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 injection flushedAlso: XylocaineThe investigator administers IV lidocaine and flushes it into the subject prior to administering propofol. | Drug | Intravenous lidocaine: flushed |
| Lidocaine injection tourniquetAlso: Xylocaine, TourniquetIntravenous lidocaine: tourniquet | Drug | Intravenous lidocaine: tourniquet |
Primary outcome
Patient Expression of Pain
Time frame: During injection at beginning of study; lasts 10 seconds one time only
Patient's verbal rating of pain during injection (see link to study protocol) We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question: How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale: * None (0) * Mild (1) * Moderate (2) * Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).
2 secondary outcomes
Subject's Recall of Injection Discomfort
Time frame: This occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time only
Investigators Rating of Patient Discomfort
Time frame: During injection at beginning of study period; lasts 10 seconds one time only
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Timothy N Harwood, MD principal investigator
Wake Forest University Health Sciences
Patrick Grace, MD study director
Wake Forest University Health Sciences
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 injection flushed and Lidocaine injection tourniquet in people with Injections, Intravenous, run by Wake Forest University Health Sciences 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 10 Sep 2018. 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. 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 13 Feb 2018). 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?
Patient Expression of Pain (time frame: During injection at beginning of study; lasts 10 seconds one time only). 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 10 Sep 2018.