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Completed

NCT Number: NCT01231204

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

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.

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Key information

Conditions

Paravertebral Catheter Insertion Breast Cancer Breast Diseases Breast Neoplasms Mastectomy Mastodynia Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UCSD Thornton Hospital

La Jolla, California, 92093, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo (normal saline) Continuous Infusion

Procedure

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

Procedure

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.

Primary outcomes

  1. Pain Scores (NRS)

    Time frame: Day following Surgery

    Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory

Secondary outcomes

  1. Pain scores

    Time frame: First 4 postoperative days

    Measured on the NRS (defined above) during the first 4 postoperative days

  2. Opioid Requirements

    Time frame: First 4 postoperative days

    Both in and out of the hospital during the first 3 postoperative days

  3. Opioid-related side effects

    Time frame: First 4 postoperative days

    Both in and out of the hospital during the first 4 postoperative days

  4. Sleep Disturbances

    Time frame: First 4 postoperative days

    Due to breast pain during the first 4 postoperative days

  5. Cancer Recurrence

    Time frame: One Year following Surgery

    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

  6. Pain and Physical Functioning

    Time frame: Within first year of surgery

    Brief Pain Inventory given by phone on postop day 1, 4, 8; and weeks 4, 12; and months 3 and 12

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2016
First posted
Nov 1, 2010
Registry last updated
Apr 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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