A Comparison of Tumescence in Breast Reduction Surgery

Pain, Postoperative Clinical Trial

Official title:

A Comparison of Tumescence in Breast Reduction Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602692
• Other study ID #: 2011-0543
• Secondary ID: A539730SMPH/SURG
• Status: Completed
• Phase: Phase 4
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Postoperative pain is often undermanaged in surgical patients. In the outpatient surgery population, such as breast reduction surgery, postoperative pain can lead to increased narcotic use, increased nausea, surgical complications and unplanned hospital admission, in addition to patient discomfort or dissatisfaction. Tumescence is a method of infiltrating tissues, such as the breast, with solutions of very dilute lidocaine and/or very dilute epinephrine in order to provide diffuse local anesthesia, hemostasis, and tissue manipulation. Both types of solution are considered standard care and both at the University of Wisconsin, Madison. There are two main aims to this study. Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. Aim 2 of our study is to determine the effect of dilute lidocaine in tumescent solution on secondary post-operative outcomes following breast reduction surgery. The secondary outcomes that will be measured in this study include average time (minutes) spent in the postanesthesia care unit (PACU), average time (minutes) spent in Phase 2, total time (minutes) between the end of case and discharge home, occurrence of unplanned hospital admission, number of episodes of post-operative nausea (subjective feeling vs. emesis) and amount of anti-emetic medication used in pacu, phase 2 and the first 24 hours post-op (mg). The investigators hypothesize that tumescence with lidocaine and epinephrine will have improved post-operative pain control leading to less narcotic use during the first twenty four hours postoperatively. (Aim 1). The investigators also believe that tumescence with lidocaine and epinephrine will lead to less time spent in PACU, less time spent in Phase2, less time between the end of the case and discharge home, less occurrence of unplanned hospital admissions, less episodes of post-operative nausea and less amount of antiemetic medication used in PACU, phase 2 and the first 24 hours post-op (Aim 2). The investigators propose that such differences could play a significant role in surgical outcomes and patient satisfaction in outpatient plastic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients presenting for breast reduction surgery at the University of Wisconsin Hospital and Clinics and the University of Wisconsin Transformations Surgery Center and who do not meet any of the exclusion criteria.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Nausea
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Tumescent solution with dilute lidocaine and epinephrine
Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
• Tumescent Solution with dilute epinephrine
Tumescent Solution containing dilute epinephrine (1:1,000,000) only

Locations

Country	Name	City	State
United States	University of Wisconsin Transformations Surgery Center	Middleton	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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

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):1010-8. doi: 10.1097/PRS.0b013e3181858c09. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Post Operative Nausea and Vomiting	The secondary outcomes that will be measured in this study include number of episodes of post-operative nausea (subjective feeling vs. emesis). This data will be attained by reviewing the medical record and through the validated survey questions.	Up to 24 hours following surgery
Secondary	Anti-emetic / Intraoperative Medication Administered (mg)	The secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions.	Up to 24 hours following surgery
Secondary	Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms)	The secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions.	Up to 24 hours following surgery
Secondary	Time to Discharge	The patient's medical record will be reviewed to determine the time it took for the patient to be transitioned from the PACU (post anesthesia care unit) till discharge. This includes the time spent in the PACU, time spent in phase 2 and the total time to discharge.	Up to 24 hours following surgery
Secondary	Unplanned Hospital Readmission	The patient's medical record will be reviewed to see if the patient was readmitted to the hospital (unplanned) due to complications related to this surgery.	Up to 1 week following surgery