Speeding Recovery From Pain and Opioid Use
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03388814|
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : July 16, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Speeding Recovery From Pain and Opioid Use After Mastectomy and Breast Reconstruction Surgery|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
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.
- 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.
- 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.
- 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
- 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.
- Readmission rates [ Time Frame: 6 months after mastectomy and breast reconstruction ]Readmission rates to the hospital within 6 months after mastectomy and breast reconstruction.
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
|Contact: Doug Jaffe, DOfirstname.lastname@example.org|
|Contact: Cecilia Rambaratemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Cecilia Rambarat 3367166709 email@example.com|
|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|
|Principal Investigator:||Doug Jaffe, DO||Wake Forest University Health Sciences|