Speeding Recovery From Pain and Opioid Use

November 28, 2018 updated by: Wake Forest University Health Sciences

Speeding Recovery From Pain and Opioid Use After Mastectomy and Breast Reconstruction Surgery

Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living. However, breast reconstruction at the same time as mastectomy has been linked to higher postoperative pain, which can be a risk factor for persistent pain. The goal of this study is to determine the speed of recovery from pain and opioid use in the first 2 months after breast surgery and reconstruction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living. Surgical treatments can also negatively influence social exposure and alter self-perception and sexual health. Reconstruction of the breast mound following mastectomy has several benefits in psychosocial functioning, body image and satisfaction with breast appearance, and sexual well-being. However, reconstruction at the same time as mastectomy has been linked to higher postoperative pain. Compared to autologous breast reconstruction, implant based techniques have been linked to higher requirements of postoperative nonsteroidal anti-inflammatory drugs, opioids, and benzodiazepines as well as higher pain scores in the immediate postoperative period and one year after surgery. Recent publications report that intensity of pain in the operative area prior to surgery, body mass index (BMI), presence of axillary operation, intensity of acute postoperative pain, and amount of opioid required to achieve satisfactory analgesia in the acute postoperative period are also risk factors for persistent pain following breast cancer surgery (PPBCS). Since severity of acute postoperative pain is consistently observed as a risk factor for persistent pain, there has been interest in determining whether better acute pain control reduces this risk. Infiltration of the surgical site with bupivacaine decreases intraoperative and postoperative narcotic use, and has been associated with decreased pain scores in the immediate postoperative period. A novel approach to hemithoracic analgesia has been introduced which proposed less risk of anatomic trespass by doing a local anesthetic injection into the fascial planes of the chest wall. These procedures have demonstrated improved analgesia for breast surgeries. Unfortunately, there is a lack of large, multicenter, prospective, and randomized trials comparing these analgesic modalities and evaluating the response to these acute postoperative analgesic interventions with regard to PPBCS and other metrics of daily function, satisfaction with pain control, and self-perception of well-being and predictors of recovery from the pain state. The goals of this research are to provide short-term surrogate measures for prevention or treatment trials and to develop methods enabling practitioners to forecast recovery in real-time and that are translatable to patients in understandable references regarding risk over time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients scheduled for unilateral mastectomy with immediate issue expander and implant based reconstruction.
  • Age ≥ 18 years
  • Ability to understand, read, and write English, and the willingness to sign an IRB-approved informed consent document.
  • Patients who receive a tissue expander placement will be included in the study.
  • American Society of Anesthesiologists physical status I-III patients.

Exclusion Criteria:

  • Patients who receive an autologous tissue reconstruction.
  • Patients who receive a bilateral reconstruction.
  • Patients who receive a direct to permanent implant reconstruction
  • Patients with diagnosis of opioid misuse disorder or on high dose opioid therapy (greater than 100 mg equivalents of oral morphine per day)
  • Patients who are wards of the state
  • Patients who cannot read or speak English
  • History of allergic reactions attributed to compounds with known or suspected cross-sensitivity to bupivacaine.
  • Pregnant or breast feeding
  • Inability to access to the internet on a daily basis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Bupivacaine Group
Those patients randomized to surgeon infiltration will have a skin wheal performed with lidocaine at the site where an actual pectoralis nerve block would be performed as visualized using ultrasound. Surgeons performing infiltration techniques will be blinded to the contents of the injectate and those patients randomized to surgeon infiltration will receive pharmacy study drug labeled bupivacaine injected in the same fashion and volume as the saline group for oncologic and plastic surgery.
Drug: Local infiltration of bupivacaine
Patients assigned to the local infiltration with bupivacaine group will receive 30 ml of 0.25% bupivacaine with 1:200,000 epinephrine. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. The local anesthetic will be injected into the chest wall and skin flaps. Attending physicians and resident physicians will receive prior instruction regarding correct placement of the local anesthetic so that it will be consistently placed in the same locations with similar volume distribution.
Experimental: Pectoralis Nerve block Group
Those patients who are randomized to pectoralis nerve block will have randomization immediately preoperatively and will undergo the nerve block procedure using local anesthetic in the standard fashion. Those patients randomized to pectoralis block will have a standard volume of normal saline injected for oncologic and plastic surgery.
Drug: Pectoralis Nerve block
Patients assigned to the pectoralis block group will receive a total of 20 ml 0.25% bupivacaine (with 1:200,000 epinephrine and 1.67 mcg clonidine per ml) in the tissue plane between the serratus anterior and the pectoralis minor muscles at approximately the level of the 4th rib and 10 ml of the same solution in the tissue plane between the two pectoralis muscles at approximately the 3rd rib under ultrasound guidance on the surgical side preoperatively.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Modeled worst pain intensity using the numeric rating scale (NRS)
Time Frame: From study start to 2 months after surgery
NRS pain scores will be obtained daily from time of initiation into the study until 2 months after surgery and the scores following hospital discharge will be modeled for each individual using a growth curve change-point approach. The NRS has a 0-10 numeric rating scale (0=no pain and 10=worst pain imaginable), where lower scores denotes better outcomes.
From study start to 2 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the curve of the numeric rating scale (NRS)
Time Frame: During the first 48 hours postoperatively
The NRS has a 0-10 numeric rating scale (0=no pain and 10=worst pain imaginable), where lower scores denotes better outcomes.
During the first 48 hours postoperatively
Opioid use
Time Frame: From admission to 2 months after surgery
Opioid use converted to morphine equivalents while in hospital and daily for the first 2 months after surgery
From admission to 2 months after surgery
Length of stay for hospitalization
Time Frame: At Discharge (up to 30 days)
Length of stay for hospitalization after mastectomy and breast reconstruction. Time is counted from admission to hospital discharged.
At Discharge (up to 30 days)
Readmission rates
Time Frame: 6 months after mastectomy and breast reconstruction
Readmission rates to the hospital within 6 months after mastectomy and breast reconstruction.
6 months after mastectomy and breast reconstruction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Doug Jaffe, DO, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00047335

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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