Evaluating the Use of Enhanced Recovery Strategies and Paravertebral Block in Elective Breast Reduction and Breast Augmentation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Numerical Pain Scores, Rated by Patient on 0-10 Scale
研究概览
简要总结
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.
详细描述
Bilateral breast reduction and bilateral breast augmentation are both routine plastic surgery procedures commonly performed on an outpatient basis. While patient satisfaction following these procedures is high, postoperative pain management can be challenging, resulting in decreased patient satisfaction, delayed recovery including delayed return to work and daily activities, increased opioid pain medication requirements and occasionally unplanned hospital admissions, surgical complications, and increased cost of care.
PVB is a common procedure used for analgesia in breast surgery in combination with multimodal perioperative pain regimens, though its use has not been formally studied in a prospective fashion. To date, no prospective, randomized, blinded study has been performed to evaluate the efficacy of PVB on perioperative pain management in this patient population.
The overarching goal of this study is to evaluate the safety and efficacy of PVB alone, as well as in conjunction with a global set of perioperative enhanced recovery strategies in elective breast surgery. The investigators hypothesize that the use of such strategies will improve the patient experience of breast reduction and augmentation beyond the current standard of care.
There are four serial aims of this study. The overarching goal of the study 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.
Following completion of all 4 groups, the investigators will be able to assess the impact of PVB alone as well as the impact of ERABS strategies in both breast reduction and breast augmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •Minors or under the age of 18
- •Pregnant or breast feeding women
- •Incarcerated women
- •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.
研究组 & 干预措施
Group 1 Arm A
Breast reduction with Paravertebral block using local anesthetic.
干预措施: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline (Procedure)
Group 1 Arm A
Breast reduction with Paravertebral block using local anesthetic.
干预措施: Paravertebral block using local anesthetic (Drug)
Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
干预措施: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline (Procedure)
Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
干预措施: Sham paravertebral block using saline (Procedure)
Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
干预措施: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline (Procedure)
Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
干预措施: Paravertebral block using local anesthetic (Drug)
Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
干预措施: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline (Procedure)
Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
干预措施: Sham paravertebral block using saline (Procedure)
Group 3 Arm A
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
干预措施: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline (Procedure)
Group 3 Arm A
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
干预措施: Enhanced recovery after breast surgery (ERABS) strategies (Other)
Group 4 Arm A
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
干预措施: Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline (Procedure)
Group 4 Arm A
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
干预措施: Enhanced recovery after breast surgery (ERABS) strategies (Other)
Group 4 Arm A
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
干预措施: Paravertebral block using local anesthetic (Drug)
结局指标
主要结局
Numerical Pain Scores, Rated by Patient on 0-10 Scale
时间窗: Postoperative day 1
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.
次要结局
- 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)
- Time Spent in Each Phase of Care Prior to Discharge(Day of surgery)
- Time to Discharge to Home(Day of surgery)
- Patients' Assessment of Perceived Quality of Recovery Using Modified Quality of Recovery Survey (MQOR-40)(1 week after surgery)
- Numerical Pain Scores, Rated by Patient on 0-10 Scale(Day of surgery)
- Anti-emetic Requirements Measured as Number of Participants Taking Anti-nausea Medication Post-Operatively Day 7(1 week after surgery)