A Comparison of Tumescence in Breast Reduction Surgery

NCT01602692 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: 2011-0543A539730SMPH/SURGERY/DENT&P SRG
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' main hypothesis is that in breast reduction surgery, the use of tumescent solution containing both dilute lidocaine and epinephrine will lead to better control of postoperative pain, nausea, vomiting, shorter time through postoperative phases of care, quicker discharge from the hospital and lower numbers of hospital readmissions than the use of tumescent solution containing only dilute epinephrine.

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Keywords

Pain, postoperative; Postoperative Nausea and Vomiting; Patient Readmission; Time to Discharge

Outcome Measures

Primary Outcomes (2)

• Post-operative Pain

  Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The data points that will be statistically compared will be pain scores determined via a validated pain survey (pain levels on a scale of 0-10 where 10 is the worst pain) and the amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined from responses to survey questions and by reviewing the medical record.

  Up to 24 hours following surgery

• Amount of Post-Operative Narcotic Medication Administered

  Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined by reviewing the medical record.

  Up to 24 hours following surgery

Secondary Outcomes (5)

• Post Operative Nausea and Vomiting

  Up to 24 hours following surgery

• Anti-emetic / Intraoperative Medication Administered (mg)

  Up to 24 hours following surgery

• Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms)

  Up to 24 hours following surgery

• Time to Discharge

  Up to 24 hours following surgery

• Unplanned Hospital Readmission

  Up to 1 week following surgery

Study Arms (2)

Tumescent solution with dilute epinephrine

ACTIVE COMPARATOR

Subjects in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.

Drug: Tumescent Solution with dilute epinephrine

Tumescent solution with dilute lidocaine and epinephrine

ACTIVE COMPARATOR

Subjects in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).

Drug: Tumescent solution with dilute lidocaine and epinephrine

Interventions

Tumescent solution with dilute lidocaine and epinephrine DRUG

Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)

Tumescent solution with dilute lidocaine and epinephrine

Tumescent Solution with dilute epinephrine DRUG

Tumescent Solution containing dilute epinephrine (1:1,000,000) only

Tumescent solution with dilute epinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Women under the age of 18 years
• Breast feeding or pregnant women
• Incarcerated women.
• Women unable to give consent because of impaired decision making ability.
• Women who have reported allergies to the substances that will be used in the study.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Transformations Surgery Center

Middleton, Wisconsin, 53562, United States

Location

Related Publications (11)

• Lu L, Fine NA. The efficacy of continuous local anesthetic infiltration in breast surgery: reduction mammaplasty and reconstruction. Plast Reconstr Surg. 2005 Jun;115(7):1927-34; discussion 1935-6. doi: 10.1097/01.prs.0000163332.04220.bd.

  PMID: 15923838 BACKGROUND

• Rawlani V, Kryger ZB, Lu L, Fine NA. A local anesthetic pump reduces postoperative pain and narcotic and antiemetic use in breast reconstruction surgery: a randomized controlled trial. Plast Reconstr Surg. 2008 Jul;122(1):39-52. doi: 10.1097/PRS.0b013e3181774349.

  PMID: 18594373 BACKGROUND

• Kryger ZB, Rawlani V, Lu L, Fine NA. Decreased postoperative pain, narcotic, and antiemetic use after breast reduction using a local anesthetic pain pump. Ann Plast Surg. 2008 Aug;61(2):147-52. doi: 10.1097/SAP.0b013e31815a23ef.

  PMID: 18650606 BACKGROUND

• Schurr MJ, Gordon DB, Pellino TA, Scanlon TA. Continuous local anesthetic infusion for pain management after outpatient inguinal herniorrhaphy. Surgery. 2004 Oct;136(4):761-9. doi: 10.1016/j.surg.2004.06.016.

  PMID: 15467660 BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• Quality improvement guidelines for the treatment of acute pain and cancer pain. American Pain Society Quality of Care Committee. JAMA. 1995 Dec 20;274(23):1874-80. doi: 10.1001/jama.1995.03530230060032.

  PMID: 7500539 BACKGROUND

• Klein JA. Tumescent technique for regional anesthesia permits lidocaine doses of 35 mg/kg for liposuction. J Dermatol Surg Oncol. 1990 Mar;16(3):248-63. doi: 10.1111/j.1524-4725.1990.tb03961.x.

  PMID: 2179348 BACKGROUND

• Ostad A, Kageyama N, Moy RL. Tumescent anesthesia with a lidocaine dose of 55 mg/kg is safe for liposuction. Dermatol Surg. 1996 Nov;22(11):921-7. doi: 10.1111/j.1524-4725.1996.tb00634.x.

  PMID: 9063507 BACKGROUND

• Larson JD, Gutowski KA, Marcus BC, Rao VK, Avery PG, Stacey DH, Yang RZ. The effect of electroacustimulation on postoperative nausea, vomiting, and pain in outpatient plastic surgery patients: a prospective, randomized, blinded, clinical trial. Plast Reconstr Surg. 2010 Mar;125(3):989-94. doi: 10.1097/PRS.0b013e3181ccdc23.

  PMID: 20195124 BACKGROUND

• Heller L, Kowalski AM, Wei C, Butler CE. Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for pain management after free TRAM flap breast reconstruction. Plast Reconstr Surg. 2008 Oct;122(4):1010-1018. doi: 10.1097/PRS.0b013e3181858c09.

  PMID: 18827631 BACKGROUND

• Christie BM, Kapur S, Kempton SJ, Hanson SE, Ma Y, Rao VK. A Prospective Randomized Trial Comparing the Effects of Lidocaine in Breast Reduction Surgery. Plast Reconstr Surg. 2017 May;139(5):1074e-1079e. doi: 10.1097/PRS.0000000000003243.

  PMID: 28445354 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Venkat Rao
• Organization: University of Wisconsin - Madison

rao@surgery.wisc.edu

(608) 263-1223

Study Officials

• Venkat K Rao, M.D. M.B.A

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2012
• First Posted: May 21, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 5, 2020
• Results First Posted: October 5, 2020

Record last verified: 2020-10

Locations

US (1)