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Enhanced Recovery Strategies in Elective Breast Surgery

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ClinicalTrials.gov Identifier: NCT03187080
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, any intervention that potentially minimizes opioid use may have meaningful individual and societal impact. In patients undergoing breast reduction and breast augmentation surgery, multiple techniques for managing postoperative pain are used commonly. One such technique is the use of a paravertebral block (PVB), which is a method of injecting local anesthesia into the area surrounding the spinal nerves in order to decrease sensation and pain in the chests and breasts in the setting of breast surgery. PVB is generally used concomitantly with standard multimodal perioperative pain management including cool compress, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids. All of these pain management strategies are used at the University of Wisconsin and are considered standard of care for breast surgery nationwide.

The overall purpose of this study is to evaluate interventions that aim to optimize pain control, minimize the risk of PONV, and improve recovery after elective breast surgery. We will do this by (1) Comparing PVB with standard pain management strategies in patients undergoing planned breast reduction and breast augmentation, and (2) Comparing "enhanced recovery after surgery" (ERAS) strategies to standard of care for patients undergoing planned breast reduction and breast augmentation. This will be studied using pain assessments, validated surveys, medication logs, and review of medical records.


Condition or disease Intervention/treatment Phase
Pain, Acute Nausea Vomiting, Postoperative Opioid Use Satisfaction Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline Other: Enhanced recovery after breast surgery (ERABS) strategies Procedure: Sham paravertebral block using saline Drug: Paravertebral block using local anesthetic Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: There are four serial aims of this study. The overarching goal is to prospectively assess the use of PVB as an adjunct for postoperative pain control both alone and in the setting of related ERABS strategies in elective breast surgery (both breast reduction and breast augmentation, two of the most common non-oncologic breast operations performed in an ambulatory setting). The methodologies used to assess postoperative pain, the set of collective ERABS strategies, the potential risks and benefits of study participation, and the inclusion/exclusion criteria will be the same in the groups studying breast reduction and those studying breast augmentation. As both operations are performed on a regular basis in the PI's practice, we feel it essential to evaluate both operations.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Participants will be blinded as to which treatment arm within their group that they are allocated. The surgery team including the surgeon (PI) and resident will be blinded as well. Anesthesiologists will not be blinded.
Primary Purpose: Treatment
Official Title: Evaluating the Use of Enhanced Recovery Strategies and Paravertebral Block in Elective Breast Reduction and Breast Augmentation
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 Arm A
Breast reduction with Paravertebral block using local anesthetic.
Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of 0.25% bupivacaine with 2.5 mcg/mL of epinephrine will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.

Drug: Paravertebral block using local anesthetic
Use of local anesthetic (0.25% bupivacaine) that is *NOT* an experimental drug but will be used as part of the paravertebral block to provide local anesthetic. This will not be given to those in the sham block groups.

Sham Comparator: Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of 0.25% bupivacaine with 2.5 mcg/mL of epinephrine will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.

Procedure: Sham paravertebral block using saline
Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of sterile saline will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.

Experimental: Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of 0.25% bupivacaine with 2.5 mcg/mL of epinephrine will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.

Drug: Paravertebral block using local anesthetic
Use of local anesthetic (0.25% bupivacaine) that is *NOT* an experimental drug but will be used as part of the paravertebral block to provide local anesthetic. This will not be given to those in the sham block groups.

Sham Comparator: Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of 0.25% bupivacaine with 2.5 mcg/mL of epinephrine will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.

Procedure: Sham paravertebral block using saline
Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of sterile saline will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.

Experimental: Group 3 Arm A
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of 0.25% bupivacaine with 2.5 mcg/mL of epinephrine will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.

Other: Enhanced recovery after breast surgery (ERABS) strategies

For comparing ERABS strategies to our current standard of care, we will utilize the following perioperative strategies [Arsalani]:

  • Standardized written information given preoperatively.
  • Allow clear liquids for up to 2 hours prior to arrival at the surgery center.
  • Use paravertebral block to augment postoperative pain control.
  • Standardized multimodal analgesic regimen
  • Antiemetics
  • Easily accessible call-in or walk-in postop care/support

The proposed strategies differ from standard of care in the following ways:

  • PVB is less commonly used in elective surgery.
  • Patients do not eat or drink after midnight.
  • There is no standardized preoperative information packet.
  • Anesthetic/intraoperative analgesic and antiemetic regimen varies between providers.

No Intervention: Group 3 Arm B
Breast reduction, standard perioperative management.
Experimental: Group 4 Arm A
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline
Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of 0.25% bupivacaine with 2.5 mcg/mL of epinephrine will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.

Other: Enhanced recovery after breast surgery (ERABS) strategies

For comparing ERABS strategies to our current standard of care, we will utilize the following perioperative strategies [Arsalani]:

  • Standardized written information given preoperatively.
  • Allow clear liquids for up to 2 hours prior to arrival at the surgery center.
  • Use paravertebral block to augment postoperative pain control.
  • Standardized multimodal analgesic regimen
  • Antiemetics
  • Easily accessible call-in or walk-in postop care/support

The proposed strategies differ from standard of care in the following ways:

  • PVB is less commonly used in elective surgery.
  • Patients do not eat or drink after midnight.
  • There is no standardized preoperative information packet.
  • Anesthetic/intraoperative analgesic and antiemetic regimen varies between providers.

Drug: Paravertebral block using local anesthetic
Use of local anesthetic (0.25% bupivacaine) that is *NOT* an experimental drug but will be used as part of the paravertebral block to provide local anesthetic. This will not be given to those in the sham block groups.

No Intervention: Group 4 Arm B
Breast augmentation, standard perioperative management.



Primary Outcome Measures :
  1. Numerical Pain Scores, rated by patient on 0-10 scale [ Time Frame: Postoperative day 1. ]
    Our primary outcome of interest is self-reported pain (0-10 visual analog scale) on post-operative day 1 (POD1).


Secondary Outcome Measures :
  1. Numerical Pain Scores, rated by patient on 0-10 scale [ Time Frame: Day of surgery ]
    Pain scores in PACU/recovery area

  2. Time spent in each phase of care prior to discharge [ Time Frame: Day of surgery ]
    Time spent in recovery after surgery

  3. Time to discharge to home [ Time Frame: Day of surgery ]
    Time between conclusion of surgery and discharge from the surgery center

  4. Analgesic requirements (pain medication quantity) [ Time Frame: 1 week after surgery ]
    Quantity and frequency of pain medication usage

  5. Post-operative nausea and vomiting (subjective report) [ Time Frame: 1 week after surgery ]
    Occurrence of nausea and vomiting after surgery

  6. Anti-emetic requirements (anti-nausea medication quantity) [ Time Frame: 1 week after surgery ]
    Use of anti-nausea mediation postoperatively

  7. Patients' assessment of perceived quality of recovery using Modified Quality of Recovery Survey (MQOR-40) [ Time Frame: 1 week after surgery ]
    Patients' assessment of quality of recovery using validated 'quality of recovery 40' survey



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age equal to and greater than 18 years.
  • Medically cleared to undergo elective breast surgery (including associated anesthesia) at UW Transformations Surgery Center.
  • Undergoing bilateral breast augmentation or bilateral breast reduction by the PI (Dr. Venkat Rao).

Exclusion Criteria:

  • Minors or under the age of 18
  • Pregnant or breast feeding women
  • Incarcerated women
  • Males
  • Individuals unable to give consent due to another condition such as impaired decision-making capacity.
  • Women who take opioid pain medications on a regular basis prior to surgery.
  • Women with a history of opioid abuse and/or dependence.
  • Women who, based on anesthesiologist discretion, are not candidates for paravertebral block.
  • Women with BMI >35
  • Women with a diagnosis of obstructive sleep apnea who are noncompliant with their treatment (e.g. CPAP use).
  • Women with a history of bleeding disorders precluding safe paravertebral block.
  • Women on anticoagulation therapy who have not held their anticoagulation as recommended by their surgeon or anesthesiologist.
  • Women with a history of infection at the site of paravertebral block.
  • Women not medically cleared for surgery at Transformations and thus would not be undergoing surgery at Transformations. This would include women with sepsis/bacteremia, significant valvular disorders or heart conditions.

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): NCT03187080


Contacts
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Contact: Jacqueline S Israel, MD 7152109959 jisrael@uwhealth.org

Locations
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United States, Wisconsin
University of Wisconsin Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Jacqueline Israel, MD    715-210-9959    jisrael@uwhealth.org   
Contact: Stephany Marten    6082631367    marten@surgery.wisc.edu   
Principal Investigator: Venkat K Rao, MD, MBA         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Venkat K Rao, MD, MBA University of Wisconsin, Madison

Publications:

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03187080     History of Changes
Other Study ID Numbers: UW 2016-1388
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

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