Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks

Breast Cancer Clinical Trial

Official title:

Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231204
• Other study ID #: PVB Catheter Study
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2010
• Last updated: April 7, 2016
• Start date: October 2010
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Research study to determine if putting local anesthetic—or numbing medication—through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.

Description:

Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of a multiple-day ambulatory continuous paravertebral block decreases the incidence and severity of post-mastectomy pain.

Hypothesis 1: Following mastectomy, the incidence and severity of breast pain will be significantly decreased in the week following surgery with a multiple-day ambulatory continuous paravertebral block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Hypothesis 2: Following mastectomy, the incidence and severity of chronic pain will be significantly decreased three months following multiple-day ambulatory continuous paravertebral blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• undergoing unilateral or bilateral mastectomy

• desiring analgesia with a paravertebral nerve block(s)

• age 18 years or older

• female

Exclusion Criteria:

• morbid obesity as defined by a body mass index > 40

• renal insufficiency

• chronic opioid use

• history of opioid abuse

• any comorbidity which results in moderate or severe functional limitation

• inability to communicate with the investigators or hospital staff

• pregnancy

• incarceration

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Mastectomy
• Mastodynia
• Paravertebral Catheter Insertion

Intervention

Procedure:
• Placebo (normal saline) Continuous Infusion
Patients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with normal saline. The normal saline infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed.
• Ropivicaine 0.4% Continuous Infusion
Patients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with 0.4%Ropivicaine. The 0.4%Ropivicaine infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed.

Locations

Country	Name	City	State
United States	UCSD Thornton Hospital	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores (NRS)	Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory	Day following Surgery	No
Secondary	Pain scores	Measured on the NRS (defined above) during the first 4 postoperative days	First 4 postoperative days	No
Secondary	Opioid Requirements	Both in and out of the hospital during the first 3 postoperative days	First 4 postoperative days	No
Secondary	Opioid-related side effects	Both in and out of the hospital during the first 4 postoperative days	First 4 postoperative days	No
Secondary	Sleep Disturbances	Due to breast pain during the first 4 postoperative days	First 4 postoperative days	No
Secondary	Cancer Recurrence	Patients' records will be investigated for indications of cancer recurrence up to 3 years following catheter placement (including estrogen receptor status as + or -). Patients may be contacted by phone if records suggest that the patient has not returned to the original surgeon within the previous 12 months	One Year following Surgery	No
Secondary	Pain and Physical Functioning	Brief Pain Inventory given by phone on postop day 1, 4, 8; and weeks 4, 12; and months 3 and 12	Within first year of surgery	No