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In order to determine if Intralipid 20% can be used to reverse the effects of local anesthetics, the investigators will recruit 18 volunteers who will be asked to come to HSS for two study visits. Small amounts of local anesthetics will be injected into the volunteers' thighs during both visits. During one visit volunteers will receive Intralipid 20% and during the other visit they will receive a saline solution. The study team will measure how quickly normal sensation returns to the thighs when the volunteers get Intralipid 20% compared to saline.
The purpose of this study is to determine if a fat solution (Intralipid 20%) given intravenously can reverse the effects of local anesthetics. Local anesthetics are drugs that cause numbness when they are injected into different parts of the body. Local anesthetics are important drugs because they allow doctors to perform surgeries and other procedures on patients; however, there are certain instances where it would be helpful to reverse the effects of local anesthetics and reduce the amount of time that they produce numbness. In order to determine if Intralipid 20% can be used to reverse the effects of local anesthetics, the investigators will recruit 18 volunteers who will be asked to come to HSS for two study visits. Small amounts of local anesthetics will be injected into the volunteers' thighs during both visits. During one visit volunteers will receive Intralipid 20% and during the other visit they will receive a saline solution. The study team will measure how quickly normal sensation returns to the thighs when the volunteers get Intralipid 20% compared to saline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralipid 20% IV Bolus | Experimental | This is 1 out of the 2 study visits. The patient will receive 6 injections (3 in each thigh). The 6 injections are:
Each test solution will be injected over 5 seconds through a 27G needle and tuberculin syringe at a 30 degree angle. The patient will also receive an intravenous bolus in the arm of Intralipid 20%. Participant will be blindfolded for these activities so they will not know what they received during the visit. |
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| Saline | Placebo Comparator | This is 2 out of the 2 study visits. The patient will receive 6 injections (3 in each thigh). The 6 injections are:
Each test solution will be injected over 5 seconds through a 27G needle and tuberculin syringe at a 30 degree angle. The patient will also receive an intravenous bolus in the arm of Saline. Participant will be blindfolded for these activities so they will not know what they received during the visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 2% | Drug | 3 mL of test solution to a skin area on the thigh, 2cm in diameter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete normal sensation after lidocaine 1% | The time (measured in minutes) when the participant reports normal sensation of both cold swab and pinprick at the injection site of lidocaine 1%. Although measured for each individual participant, the average time across all participants is reported. | up to 24 hours |
| Time to complete normal sensation after lidocaine 2% | The time (measured in minutes) when the participant reports normal sensation of both cold swab and pinprick at the injection site of lidocaine 2%. Although measured for each individual participant, the average time across all participants is reported. | up to 24 hours |
| Time to complete normal sensation after Bupivacaine 0.5% | The time (measured in minutes) when the participant reports normal sensation of both cold swab and pinprick at the injection site of Bupivacaine 0.5%. Although measured for each individual participant, the average time across all participants is reported. | up to 24 hours |
| Time to complete normal sensation after Bupivacaine 0.25% | The time (measured in minutes) when the participant reports normal sensation of both cold swab and pinprick at the injection site of Bupivacaine 0.25%. Although measured for each individual participant, the average time across all participants is reported. | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to normal cold swab sensation after lidocaine 1% | The time (measured in minutes) when the participant reports normal sensation of cold swab at the injection site of lidocaine 1%. Although measured for each individual participant, the average time across all participants is reported. | up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stavros Memtsoudis, MD/PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Special Surgery | New York | New York | 10021 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures)
Beginning 9 months and ending 36 months following article publication
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our data warehouse but without investigator support other than deposited metadata.
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C511998 | Lidoderm |
| D002045 | Bupivacaine |
| C545823 | soybean oil, phospholipid emulsion |
| D012492 | Salts |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Patients will be blinded to which treatment they are receiving both times they come in for the study.
| Lidocaine 1% | Drug | 3 mL of test solution to a skin area on the thigh, 2cm in diameter |
|
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| Bupivacaine 0.25% | Drug | 3 mL of test solution to a skin area on the thigh, 2cm in diameter |
|
|
| Bupivacaine 0.5% | Drug | 3 mL of test solution to a skin area on the thigh, 2cm in diameter |
|
|
| Intralipid, 20% Intravenous | Drug | a 250ml bag administered intravenously |
|
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| Saline intravenously | Other | a 250ml bag administered intravenously |
|
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| Saline | Other | 3 mL of test solution to a skin area on the thigh, 2cm in diameter |
|
|
| Time to normal pinprick sensation after lidocaine 1% |
The time (measured in minutes) when the participant reports normal sensation of pinprick at the injection site of lidocaine 1%. Although measured for each individual participant, the average time across all participants is reported. |
| up to 24 hours |
| Time to normal cold swab sensation after lidocaine 2% | The time (measured in minutes) when the participant reports normal sensation of cold swab at the injection site of lidocaine 2%. Although measured for each individual participant, the average time across all participants is reported. | up to 24 hours |
| Time to normal pin prick sensation after lidocaine 2% | The time (measured in minutes) when the participant reports normal sensation of pinprick at the injection site of lidocaine 2%. Although measured for each individual participant, the average time across all participants is reported. | up to 24 hours |
| Time to normal pinprick sensation after Bupivacaine 0.5% | The time (measured in minutes) when the participant reports normal sensation of pinprick at the injection site of Bupivacaine 0.5%. Although measured for each individual participant, the average time across all participants is reported. | up to 24 hours |
| Time to normal cold swab sensation after Bupivacaine 0.5% | The time (measured in minutes) when the participant reports normal sensation of cold swab at the injection site of Bupivacaine 0.5%. Although measured for each individual participant, the average time across all participants is reported. | up to 24 hours |
| Time to normal cold swab sensation after Bupivacaine 0.25% | The time (measured in minutes) when the participant reports normal sensation of cold swab at the injection site of Bupivacaine 0.25%. Although measured for each individual participant, the average time across all participants is reported. | up to 24 hours |
| Time to normal pinprick sensation after Bupivacaine 0.25% | The time (measured in minutes) when the participant reports normal sensation of pinprick at the injection site of Bupivacaine 0.25%. Although measured for each individual participant, the average time across all participants is reported. | up to 24 hours |
| Aniline Compounds |
| D000588 | Amines |
| D007287 | Inorganic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |