Enhanced Recovery Strategies in Elective Breast Surgery

NCT03187080 | Terminated Phase 4 Results FDA Drug

• 4 other identifiers: 2016-1388A539730SMPH\SURGERY\DENT&P SRGProtocol Version 4/9/2021
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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. The investigators 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.

Conditions

Pain, Acute; Nausea; Vomiting, Postoperative; Opioid Use; Satisfaction

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Scores, Rated by Patient on 0-10 Scale

  Our primary outcome of interest is self-reported pain (0-10 visual analog scale) on post-operative day 1 (POD1). Higher scores indicates higher levels of pain.

  Postoperative day 1

Secondary Outcomes (7)

• Numerical Pain Scores, Rated by Patient on 0-10 Scale

  Day of surgery

• Time Spent in Each Phase of Care Prior to Discharge

  Day of surgery

• Time to Discharge to Home

  Day of surgery

• Analgesic Requirements Reported as the Number of Participants Who Were Still Taking Medications Post-Operatively Day 7

  1 week after surgery

• Post-operative Nausea and Vomiting (Subjective Report) Measured as the Mean Incidence Reported Post-Operatively Day 7

  1 week after surgery

Study Arms (8)

Group 1 Arm A

EXPERIMENTAL

Breast reduction with Paravertebral block using local anesthetic.

Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline; Drug: Paravertebral block using local anesthetic

Group 1 Arm B

SHAM COMPARATOR

Breast reduction with Sham paravertebral block using saline.

Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline; Procedure: Sham paravertebral block using saline

Group 2 Arm A

EXPERIMENTAL

Breast augmentation with Paravertebral block using local anesthetic.

Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline; Drug: Paravertebral block using local anesthetic

Group 2 Arm B

SHAM COMPARATOR

Breast augmentation with Sham paravertebral block using saline.

Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline; Procedure: Sham paravertebral block using saline

Group 3 Arm A

EXPERIMENTAL

Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.

Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline; Other: Enhanced recovery after breast surgery (ERABS) strategies

Group 3 Arm B

NO INTERVENTION

Breast reduction, standard perioperative management.

Group 4 Arm A

EXPERIMENTAL

Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.

Procedure: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline; Other: Enhanced recovery after breast surgery (ERABS) strategies; Drug: Paravertebral block using local anesthetic

Group 4 Arm B

NO INTERVENTION

Breast augmentation, standard perioperative management.

Interventions

Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline PROCEDURE

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.

Group 1 Arm A; Group 1 Arm B; Group 2 Arm A; Group 2 Arm B; Group 3 Arm A; Group 4 Arm A

Enhanced recovery after breast surgery (ERABS) strategies OTHER

For comparing ERABS strategies to current standard of care, the following perioperative strategies will be utilized: * 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.

Group 3 Arm A; Group 4 Arm A

Sham paravertebral block using saline PROCEDURE

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.

Group 1 Arm B; Group 2 Arm B

Paravertebral block using local anesthetic DRUG

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.

Group 1 Arm A; Group 2 Arm A; Group 4 Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 or MSC and thus would not be undergoing surgery at Transformations or MSC. This would include women with sepsis/bacteremia, significant valvular disorders or heart conditions.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (13)

• Bonde C, Khorasani H, Eriksen K, Wolthers M, Kehlet H, Elberg J. Introducing the fast track surgery principles can reduce length of stay after autologous breast reconstruction using free flaps: A case control study. J Plast Surg Hand Surg. 2015;49(6):367-71. doi: 10.3109/2000656X.2015.1062387. Epub 2015 Jul 10.

  PMID: 26161838 BACKGROUND

• Davis GM, Ringler SL, Short K, Sherrick D, Bengtson BP. Reduction mammaplasty: long-term efficacy, morbidity, and patient satisfaction. Plast Reconstr Surg. 1995 Oct;96(5):1106-10.

  PMID: 7568486 BACKGROUND

• Parikh RP, Sharma K, Guffey R, Myckatyn TM. Preoperative Paravertebral Block Improves Postoperative Pain Control and Reduces Hospital Length of Stay in Patients Undergoing Autologous Breast Reconstruction after Mastectomy for Breast Cancer. Ann Surg Oncol. 2016 Dec;23(13):4262-4269. doi: 10.1245/s10434-016-5471-1. Epub 2016 Aug 3.

  PMID: 27489056 BACKGROUND

• Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14.

  PMID: 20947592 BACKGROUND

• Anderson AD, McNaught CE, MacFie J, Tring I, Barker P, Mitchell CJ. Randomized clinical trial of multimodal optimization and standard perioperative surgical care. Br J Surg. 2003 Dec;90(12):1497-504. doi: 10.1002/bjs.4371.

  PMID: 14648727 BACKGROUND

• Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.

  PMID: 21236454 BACKGROUND

• Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.

  PMID: 9175983 BACKGROUND

• Arsalani-Zadeh R, ElFadl D, Yassin N, MacFie J. Evidence-based review of enhancing postoperative recovery after breast surgery. Br J Surg. 2011 Feb;98(2):181-96. doi: 10.1002/bjs.7331.

  PMID: 21104705 BACKGROUND

• Kairaluoma PM, Bachmann MS, Korpinen AK, Rosenberg PH, Pere PJ. Single-injection paravertebral block before general anesthesia enhances analgesia after breast cancer surgery with and without associated lymph node biopsy. Anesth Analg. 2004 Dec;99(6):1837-1843. doi: 10.1213/01.ANE.0000136775.15566.87.

  PMID: 15562083 BACKGROUND

• Dabbagh A, Elyasi H. The role of paravertebral block in decreasing postoperative pain in elective breast surgeries. Med Sci Monit. 2007 Oct;13(10):CR464-7.

  PMID: 17901854 BACKGROUND

• Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.

  PMID: 10825328 BACKGROUND

• Gornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, Bost JE, Kluivers KB, Nilsson UG, Tanaka Y, Forbes A. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013 Aug;111(2):161-9. doi: 10.1093/bja/aet014. Epub 2013 Mar 6.

  PMID: 23471753 BACKGROUND

• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Nausea; Postoperative Nausea and Vomiting; Personal Satisfaction

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Postoperative Complications; Pathologic Processes; Vomiting; Behavior

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Study terminated early and not powered for meaningful results.

Results Point of Contact

• Title: Venkat Rao, MD, MBA
• Organization: University of Wisconsin School of Medicine and Public Health

rao@surgery.wisc.edu

(608) 263-1223

Study Officials

• Venkat K Rao, MD, MBA

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 14, 2017
• Study Start: October 19, 2017
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)