Speeding Recovery From Pain and Opioid Use

NCT03388814 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: IRB00047335
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative; Breast Cancer; Opioid Use; Surgery

Keywords

PPBCS; Acute; Postoperative; Mastectomy; Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• Modeled worst pain intensity using the numeric rating scale (NRS)

  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 Outcomes (4)

• Area under the curve of the numeric rating scale (NRS)

  During the first 48 hours postoperatively

• Opioid use

  From admission to 2 months after surgery

• Length of stay for hospitalization

  At Discharge (up to 30 days)

• Readmission rates

  6 months after mastectomy and breast reconstruction

Study Arms (2)

Bupivacaine Group

ACTIVE COMPARATOR

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

Pectoralis Nerve block Group

EXPERIMENTAL

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

Interventions

Local infiltration of bupivacaine 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.

Bupivacaine Group

Pectoralis Nerve block 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.

Pectoralis Nerve block Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Doug Jaffe, DO

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 3, 2018
• Study Start: November 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 30, 2018

Record last verified: 2018-11