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Speeding Recovery From Pain and Opioid Use

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ClinicalTrials.gov Identifier: NCT03388814
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Breast Cancer Opioid Use Surgery Drug: Local infiltration of bupivacaine Drug: Pectoralis Nerve block Early Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Speeding Recovery From Pain and Opioid Use After Mastectomy and Breast Reconstruction Surgery
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. Readmission rates [ Time Frame: 6 months after mastectomy and breast reconstruction ]
    Readmission rates to the hospital within 6 months after mastectomy and breast reconstruction.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388814


Contacts
Contact: Doug Jaffe, DO 3367165955 jjaffe@wakehealth.edu
Contact: Cecilia Rambarat 3367166709 cgrambar@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Doug Jaffe, DO    336-716-5955    jjaffe@wakehealth.edu   
Contact: Cecilia Rambarat    3367166709    cgrambar@wakehealth.edu   
Sub-Investigator: James Eisenach, MD         
Sub-Investigator: Christopher Runyan, MD         
Sub-Investigator: Akiko Chiba, MD         
Sub-Investigator: Megan Rudolph, MD         
Sub-Investigator: Robert Weller, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Doug Jaffe, DO Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03388814     History of Changes
Other Study ID Numbers: IRB00047335
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

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

Keywords provided by Wake Forest University Health Sciences:
PPBCS
Acute
Postoperative
Mastectomy
Breast Reconstruction

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents