Regional Nerve Blocks in Alloplastic Breast Reconstructive Surgery: A Pilot, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rate of participant retention
研究概览
简要总结
Pain management is a major concern in oncologic breast surgery and reconstruction. Significant risks for acute and chronic pain after surgery might be reduced through improved pain control pre-operatively. Addition of regional anesthesia to a multimodal peri-operative pain management protocol offers a promising solution for improved recovery. For patients undergoing mastectomy with immediate alloplastic breast reconstruction, this RCT compares TPVB+Pecs local anesthetic block with TPVB local anesthetic block and Pecs placebo normal saline block for their effect on acute pain, chronic pain, opioid consumption, opioid-related side effects, patient-reported quality of recovery after surgery, and length of stay.
详细描述
OBJECTIVES
The primary objectives of the pilot trial are to demonstrate feasibility of recruitment and to demonstrate efficacy potential. The primary objectives of the definitive trial are to determine if Thoracic Paravertebral with Pecs blocks (defined as Pec I and Pec II blocks) (TPVB+Pecs) will reduce opioid consumption and chronic pain compared to a TPVB+Sham block in patients undergoing mastectomy with IBR using tissue expanders or implants. Secondary objectives of the definitive trial include assessment of opioid consumption, patient-reported postoperative pain scores, postoperative nausea and vomiting, length of stay, and patient-reported quality of recovery.
HYPOTHESIS
In breast cancer patients undergoing mastectomy with immediate implant-based breast reconstruction, the addition of a Pecs block to a thoracic paravertebral block (TPVB+Pecs) will reduce acute and chronic patient-reported postoperative pain as compared to a thoracic paravertebral block with sham Pecs block (TPVB+Sham).
Secondary hypotheses include: the TPVB+Pecs over TPVB+Sham will decrease opioid consumption, postoperative nausea and vomiting, decrease patient-reported postoperative pain scores, length of stay, and improve patient-reported quality of recovery in patients undergoing total mastectomy with IBR using tissue expanders or immediate implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be female, and at least 19 years old.
- •Patients must be ASA grade I or II.
- •Patients must be undergoing total mastectomy with IBR using tissue expander or implant, with or without axillary surgery.
排除标准
- •Patients have a known contraindication for a regional block: known coagulation disorder, treatment with anticoagulants, infection at the injection site, known allergy to medication in the study.
- •Patients who are pregnant at the time of surgery.
- •Patients having bilateral mastectomy and immediate alloplastic breast reconstruction (as only one side can be blocked to prevent local anesthesia toxicity).
- •Patients with ASA Class III or IV.
- •Patients with BMI>35kg/m
- •Patients weighing less than 50kg.
- •Patients living/staying outside of 1-hour driving distance from hospital.
研究组 & 干预措施
Local anesthetic TPVB + Sham Pecs block
Patients will receive a thoracic paravertebral with local anesthetic infiltrate and a pecs block with saline infiltrate.
干预措施: Sham Pecs block (Drug)
Local anesthetic TPVB + Local anesthetic Pecs block
Patients will receive a thoracic paravertebral with pecs block, both with local anesthetic infiltrate.
干预措施: Thoracic paravertebral block (Drug)
Local anesthetic TPVB + Local anesthetic Pecs block
Patients will receive a thoracic paravertebral with pecs block, both with local anesthetic infiltrate.
干预措施: Pecs block (Drug)
Local anesthetic TPVB + Sham Pecs block
Patients will receive a thoracic paravertebral with local anesthetic infiltrate and a pecs block with saline infiltrate.
干预措施: Thoracic paravertebral block (Drug)
结局指标
主要结局
Rate of participant retention
时间窗: 6 months
The definitive trial will be considered feasible if there is \> 90% participant retention at 6 months.
Rate of participant recruitment
时间窗: 1 year
The definitive trial will be considered feasible if \> 50% of eligible patients are enrolled in this pilot study.
Rate of successful nerve blocks
时间窗: 1 year
The definitive trial will be considered feasible if \> 90% of blocks are successful.
Average pain score in the 24-hour post-operative period assessed by the Numerical Rating Scale.
时间窗: 24 hours post-operatively
The Numerical Rating Scale is an 11-point scale (0-10), where a lower number indicates less pain. We will consider preliminary evidence of efficacy for a definitive trial if the 80% confidence interval for the between-group difference in average pain score in the 24-hour postoperative period favours LA block.
次要结局
- Time to perform ultrasound-guided TPVB+PecsII(Up to 24 hours post-operatively)
- Time under general anesthesia(Up to 24 hours post-operatively)
- Post-operative vomiting measured by number of vomiting episodes(Up to 48 hours post-operatively)
- Time in PACU(Up to 24 hours post-operatively)
- Number of participants requiring rescue opioid analgesics and anti-emetics.(Up to 7 days post-operatively)
- Number of participants with failure of early discharge.(Up to 48 hours post-operatively)
- Opioid analgesia requirements(24 hours post-operatively)
- Post-operative nausea measured by the Numerical Rating Scale(24 hours post-operatively)
- Acute patient-reported pain scores assessed by the Numerical Rating Scale(Up to 24 hours post-operatively)
- Quality of Recovery Score measured by the Quality of Recovery 15 Questionnaire(Baseline (prior to surgery) and 24 hours after surgery)
- Length of stay in hospital in hours(Up to 96 hours post-operatively)
- Number of participants with failure of discharge from PACU and requiring admission to hospital(Up to 24 hours post-operatively)
- Time to rescue opioid analgesics and anti-emetics.(Up to 7 days post-operatively)
- Number of participants with complications and adverse events(Up to 24 hours post-operatively)
研究者
Kathryn Isaac
Principal Investigator
University of British Columbia