Comparison of Single and Double Injection Ultrasound-Guided Bilateral Thoracic Paravertebral Block Effects in Patients Undergoing Reduction Mammaplasty: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain (Numeric rating scale (NRS)) score
研究概览
简要总结
This study compares the analgesic effects and dermatomal blockade distributions of single and double injection bilateral thoracic paravertebral block (TPVB) techniques in patients undergoing reduction mammaplasty.
After obtaining ethics committee approval; 60 patients scheduled for elective bilateral reduction mammoplasty and gave written informed consent, were included in the study. The patients were randomized in one of single (Group S: T3-T4) or double injections (Group D: T2-T3&T4-T5) bilateral TPVB groups (bupivacaine 0.375% 20 mL per side). All patients' dermatomal blockade distributions (T2-T6) were followed for 30 minutes, and then they were given general anesthesia. Before extubation, 1 g IV paracetamol was applied to all. Postoperatively, patients in both groups received IV paracetamol 1 g when numeric rating scale (NRS) pain score ≥4, and also tramadol 1 mg/kg if they defined NRS≥4 again after 1 h. The primary endpoint was NRS pain scores at postoperative 12th hour. The secondary endpoints were NRS scores and dermatomal blockade distributions through the postoperative first 48 hours, postoperative time until first pain, the total numbers of analgesic requirements on days 1 and 2.
详细描述
This prospective randomized controlled study compares the analgesic effects and dermatomal blockade distributions of single and double injection bilateral thoracic paravertebral block (TPVB) techniques in patients undergoing reduction mammaplasty.
After obtaining ethics committee approval; 60 patients scheduled for elective bilateral reduction mammoplasty and gave written informed consent, were included in the study. The inclusion criteria were female gender, aging between 18 and 70 years, American Society of Anesthesiologists (ASA) physical status of 1-3, capable of consenting, understanding the instructions for using the NRS pain scores and replying the study-based questions, lack of contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB, absence of mental/psychiatric disorders, chronic analgesic/opioid use and alcohol/illicit drug use. The patients were randomized in one of single (Group S: T3-T4-bupivacaine 0.375% 20 mL/injection) or double injections (Group D: T2-T3&T4-T5-bupivacaine 0.375% 10 mL/injection) bilateral TPVB groups using the sealed envelopes technique. All patients' dermatomal (sensorial) blockade distributions (T2-T6) were tested bilaterally between T2 and T6 dermatomal levels on the midclavicular line in every 5 minutes through the first 30 minutes after TPVB performances, by using the pin-prick test, and then they were given standard general anesthesia. Before extubation, 1 g IV paracetamol was applied to all. The NRS pain scores (0: no pain and 10: worst pain imaginable), and the dermatomal blockade distribution/numbers of blocked dermatomes of all patients on both sides were asked and documented on postoperative 0th min, 1st, 2nd, 6th, 12th, 24th and 48th hours. Postoperatively, patients in both groups received IV paracetamol 1 g when NRS pain score ≥4, and also tramadol 1 mg/kg if they defined NRS≥4 again after 1 h. The primary endpoint was NRS pain score at 12th hour. The secondary endpoints included the NRS pain scores and the dermatomal blockade distribution/numbers of blocked dermatomes through the postoperative first 48 hours, block application times, number of patients experienced hypotension or required fentanyl intraoperatively, length of stay in postoperative care unit (PACU), postoperative time until first pain (NRS≥4), the total numbers of paracetamol and tramadol requirements, incidence of postoperative nausea and vomiting (PONV) and duration of sleep on postoperative days 1 and 2, patient and surgeon satisfaction scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
- All TPVB procedures were performed by the same 3 senior anesthesiology residents, always under the supervision of 2 attending anesthesiologists (1 senior resident with 1 attending anesthesiologist at a time)
- Preoperatively, the anesthesiologists who were blinded to the group of that specific patient evaluated the sensorial blockade of dermatomes separately on both sides
- Postoperatively, different anesthesiologists who did not participate in the TPVB performance process of that specific patient and were totally blinded to the group again collected the data.
- Surgeons were also blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status of 1-3
- •Capable of consenting
- •Capable of understanding the instructions for using the NRS pain scores
- •Capable of replying the study-based questions
- •Lack of contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB
- •Absence of mental/psychiatric disorders
- •Absence of chronic analgesic/opioid use
- •Absence of alcohol/illicit drug use
排除标准
- •Patient refusal
- •American Society of Anesthesiologists (ASA) physical status of 4
- •Not capable of consenting
- •Not capable of understanding the instructions for using the NRS pain scores
- •Not capable of replying the study-based questions
- •Contraindications to regional anesthesia (allergy to a LA, local infection, and coagulopathy) and especially TPVB
- •Presence of mental/psychiatric disorders
- •Presence of chronic analgesic/opioid use
- •Presence of alcohol/illicit drug use
结局指标
主要结局
Pain (Numeric rating scale (NRS)) score
时间窗: 12th hour
NRS pain score (0: no pain, 10: worst pain imaginable) on postoperative 12th hour
次要结局
- Number of patients experienced hypotension intraoperatively(Intraoperative 2-4 hours)
- Incidence of postoperative nausea and vomiting (PONV)(0-48 hours)
- Patient satisfaction(0-48 hours)
- Pain (Numeric rating scale (NRS)) score(0-48 hours)
- Postoperative time until first pain(0-48 hours)
- Dermatomal blockade distribution/numbers of blocked dermatomes(0-48 hours)
- Block application time(2-20 minutes)
- Number of patients required fentanyl intraoperatively(Intraoperative 2-4 hours)
- Tramadol consumption/the total numbers of tramadol requirements(0-48 hours)
- Surgeon satisfaction(0-48 hours)
- Paracetamol consumption/the total numbers of paracetamol requirements(0-48 hours)
- Length of stay in postoanesthesia care unit (PACU)(0-1 hours)
- Duration of sleep(0-48 hours)
研究者
Emine Aysu Salviz, MD
Associate Professor
Istanbul University