Speeding Recovery From Pain and Opioid Use

NCT ID: NCT03388814

Last Updated: 2018-11-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2020-06-30

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.

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.

Conditions

Pain, Postoperative; Breast Cancer; Opioid Use; Surgery

Keywords

PPBCS; Acute; Postoperative; Mastectomy; Breast Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Local infiltration of bupivacaine

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Pectoralis Nerve block

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doug Jaffe, DO

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Countries

United States

Other Identifiers

IRB00047335

Identifier Type: -

Identifier Source: org_study_id