EndometriosisNCT01968694
Effects of Intravenous Lidocaine on Endometriosis Pain
A study testing IV Lidocaine and IV diphenhydramine in people with Endometriosis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
We are doing this research study to find out if intravenous (in your vein, "IV") lidocaine can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved intravenous lidocaine to treat irregular heart beats, but the FDA has not approved intravenous lidocaine to treat pain from… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- IV Lidocaine and IV diphenhydramine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jun 2016
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Reproductive age women ages 18 - 50
- Endometriosis diagnosed laparoscopically or by primary care physician or gynecologist using clinical criteria
- Pain for > 6 months
- Pain most intense around time of menstrual cycle. Pain at least 5 on a 0-10 scale.
- Receiving regular monthly menses (cannot be receiving Depo-provera injections)
Who cannot join
- Pregnant or breastfeeding
- On lupron therapy
- History of myocardial infarction or cardiac arrhythmias including Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular heart block in the absence of a pacemaker
- History of seizure disorder
- Significant anxiety, psychosis or other cognitive disorder limiting completion of study procedures
- History of alcohol or substance abuse
Show all 11Show fewer
- Chronic pain symptoms other than chronic pelvic pain (excluding migraine pain)
- Known hypersensitivity to amide type anesthetics
- Known hypersensitivity to diphenhydramine (benadryl)
- History of treatment with lidocaine or mexiletene
- Having or showing signs and symptoms of liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital Pain Management Center
Boston, Massachusetts, 02467
About this study
We are doing this research study to find out if intravenous (in your vein, "IV") lidocaine can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved intravenous lidocaine to treat irregular heart beats, but the FDA has not approved intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used for more than 25 years to treat different acute and chronic pain conditions but has not yet been studied for endometriosis pain.
This is a cross-over trial over two months where one month you will receive the active medication (lidocaine) and one month you will receive the active placebo (diphenhydramine, commonly known as benadryl). We will compare the effect on pain from endometriosis of lidocaine to active placebo.
- Conditions
- Endometriosis
- Being tested
- IV Lidocaine, IV diphenhydramine
- Keywords
- endometriosis, chronic pain, intravenous lidocaine
- Medical subject headings
- Endometriosis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV LidocaineDrug
IV diphenhydramineDrug
| Study group | Role | What they receive |
|---|---|---|
| IV Lidocaine | Experimental | IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes Receives: Drug: IV Lidocaine |
| IV diphenhydramine | Placebo comparator | IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes Receives: Drug: IV diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) ranges from 0 (no pain) to 10 (the worse imaginable pain).
Change scores are calculated from baseline (pre-infusion) at 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete:
(15 minutes after start of infusion value - BL pre-infusion value) (30 minutes after start of infusion value - BL pre-infusion value) (30 minutes after infusion complete value - BL pre-infusion value)
Measured: 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)
Secondary outcomes (3)
Change in Short Form McGill Pain Questionnaire 2
Short-form McGill Pain Questionnaire version 2 consists of 22 pain items (Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, Punishing-cruel, Electric-shock, Cold-freezing, Piercing, Pain caused by light touch, Itching, Tingling or 'pins and needles', and Numbness). Each item is rated on a scale from 0-10, where 0=none, and 10=worst possible pain. The total pain score is the sum of these 22 items, ranging from 0-220.
Change scores are calculated from baseline (pre-infusion) at 30 minutes, 1 week, and 1 month post-treatment:
(30 minutes post-treatment value - BL pre-infusion value)
(1 week post-treatment value - BL pre-infusion value)
(1 month post-treatment value - BL pre-infusion value)
Measured: 30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)
Change in Brief Pain Inventory (BPI): Pain on Average
The Pain on Average score in the Brief Pain Inventory is rated from 0-10, where 0 is no pain, and 10 is pain as bad as you can imagine.
Change scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:
(1 day post-treatment value - BL pre-infusion value)
(1 week post-treatment value - BL pre-infusion value)
(1 month post-treatment value - BL pre-infusion value)
Measured: 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)
Change in Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) consists of 14 items rated from 0-3 and 2 subscales Depression (7 items) and Anxiety (7 items). A higher score on each item represents more of each symptom (i.e., more depression or more anxiety). Each subscale score is the sum of the 7 items from each subscale.
A score of 0-7 = Normal, 8-10=Borderline abnormal (borderline case), and 11-21=Abnormal (case).
Change scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:
(1 day post-treatment value - BL pre-infusion value)
(1 week post-treatment value - BL pre-infusion value)
(1 month post-treatment value - BL pre-infusion value)
Measured: 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startDec 2010
- Primary completionJun 2016
- Study completionJun 2016
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 EndometriosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Antje Barreveld, MD, Brigham and Women's Hospital
- Investigators
- Antje Barreveld, MD, Principal investigator, Brigham and Women's Hospital, Newton-Wellesley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968694
- Sponsor's protocol ID
- 2010P002903
- Status last verified
- May 2017
- First submitted
- 21 Oct 2013
- Last updated
- 7 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Lidocaine on Endometriosis Pain
- ClinicalTrials.gov ID
- NCT01968694
- Acronym / sponsor ID
- 2010P002903
- Conditions
- Endometriosis
- Keywords
- endometriosis, chronic pain, intravenous lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Posted 7 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are doing this research study to find out if intravenous (in your vein, "IV") lidocaine can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved intravenous lidocaine to treat irregular heart beats, but the FDA has not approved intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used for more than 25 years to treat different acute and chronic pain conditions but has not yet been studied for endometriosis pain.
This is a cross-over trial over two months where one month you will receive the active medication (lidocaine) and one month you will receive the active placebo (diphenhydramine, commonly known as benadryl). We will compare the effect on pain from endometriosis of lidocaine to active placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Lidocaine | Experimental | Drug: IV LidocaineIV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes |
| IV diphenhydramine | Placebo comparator | Drug: IV diphenhydramineIV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Reproductive age women ages 18 - 50
- Endometriosis diagnosed laparoscopically or by primary care physician or gynecologist using clinical criteria
- Pain for > 6 months
- Pain most intense around time of menstrual cycle. Pain at least 5 on a 0-10 scale.
- Receiving regular monthly menses (cannot be receiving Depo-provera injections)
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding
- On lupron therapy
- History of myocardial infarction or cardiac arrhythmias including Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular heart block in the absence of a pacemaker
- History of seizure disorder
- Significant anxiety, psychosis or other cognitive disorder limiting completion of study procedures
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 |
|---|---|---|
| IV Lidocaine | Drug | IV Lidocaine |
| IV diphenhydramine | Drug | IV diphenhydramine |
Primary outcome
Change in Visual Analogue Scale (VAS)
Time frame: 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)
Visual Analogue Scale (VAS) ranges from 0 (no pain) to 10 (the worse imaginable pain). Change scores are calculated from baseline (pre-infusion) at 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete: (15 minutes after start of infusion value - BL pre-infusion value) (30 minutes after start of infusion value - BL pre-infusion value) (30 minutes after infusion complete value - BL pre-infusion value)
3 secondary outcomes
Change in Short Form McGill Pain Questionnaire 2
Time frame: 30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)
Change in Brief Pain Inventory (BPI): Pain on Average
Time frame: 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Antje Barreveld, MD principal investigator
Brigham and Women's Hospital, Newton-Wellesley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV Lidocaine and IV diphenhydramine in people with Endometriosis, run by Brigham and Women's Hospital 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 5 inclusion and 11 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 7 Jun 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2017). 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?
Change in Visual Analogue Scale (VAS) (time frame: 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)). 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 7 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.