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| ID | Type | Description | Link |
|---|---|---|---|
| HMS-LIPO-001 |
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RCT of S/E of lidocaine infiltration in tumescent technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Active Comparator | Infiltration with 0.9% saline+1:1,000,000 epinephrine+0.06% Lidocaine |
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| II | Placebo Comparator | Infiltration with 0.9% saline+1:1,000,000 epinephrine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Subcutaneous infiltration with Active/Placebo solutions with tumescent technique previous to suction assisted lipectomy. Patient abdomen and back will be divided in 4 zones anterior and posterior, one side (left or right) will be infiltrated with active solution and the other with placebo. The allocation of the side will be made with random numbers. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain (VSA) | 1, 6, 12, 18 and 24 post operative hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue medication | 1, 6, 12, 15 and 24 hours postoperative | |
| Nausea, emesis, arrythmia, seizures, arrest, shock, death. | 24 hours postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Danilla, MD, MSc | Hospital Militar de Santiago | Principal Investigator |
| Guillermo Israel, MD | Hospital Militar de Santiago | Study Chair |
| Montserrat Fontbona, MD | Hospital Militar de Santiago | Study Chair |
| Rodrigo Cabello, MD | Hospital Militar de Santiago | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Militar de Santiago | Santiago | RM | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8780763 | Background | Kaplan B, Moy RL. Comparison of room temperature and warmed local anesthetic solution for tumescent liposuction. A randomized double-blind study. Dermatol Surg. 1996 Aug;22(8):707-9. doi: 10.1111/j.1524-4725.1996.tb00621.x. | |
| 16970691 | Background | Yang CH, Hsu HC, Shen SC, Juan WH, Hong HS, Chen CH. Warm and neutral tumescent anesthetic solutions are essential factors for a less painful injection. Dermatol Surg. 2006 Sep;32(9):1119-22; discussion 1123. doi: 10.1111/j.1524-4725.2006.32254.x. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 26, 2013 | |
| Reset | Nov 5, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 26, 2013 | Nov 5, 2013 |
| ID | Term |
|---|---|
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 10077095 | Background | Rubin JP, Bierman C, Rosow CE, Arthur GR, Chang Y, Courtiss EH, May JW Jr. The tumescent technique: the effect of high tissue pressure and dilute epinephrine on absorption of lidocaine. Plast Reconstr Surg. 1999 Mar;103(3):990-6; discussion 997-1002. |
| 15861085 | Background | Rubin JP, Xie Z, Davidson C, Rosow CE, Chang Y, May JW Jr. Rapid absorption of tumescent lidocaine above the clavicles: a prospective clinical study. Plast Reconstr Surg. 2005 May;115(6):1744-51. doi: 10.1097/01.prs.0000161678.10555.53. |
| 23897332 | Derived | Danilla S, Fontbona M, de Valdes VD, Dagnino B, Sorolla JP, Israel G, Searle S, Norambuena H, Cabello R. Analgesic efficacy of lidocaine for suction-assisted lipectomy with tumescent technique under general anesthesia: a randomized, double-masked, controlled trial. Plast Reconstr Surg. 2013 Aug;132(2):327-332. doi: 10.1097/PRS.0b013e3182958b20. |
| Aniline Compounds |
| D000588 | Amines |