Comparison of the Analgesic Effects of Modified Thoracoabdominal Nerve Block Through Pericondrial Approach (M-TAPA) and Transversus Abdominis Plane (TAP) Block in Laparoscopic Inguinal Hernia Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Comparing the numerical rating scale scores
研究概览
简要总结
The goal of this study is to compare the analgesic efficacy of M-TAPA block and TAP block in patients undergoing laparoscopic inguinal hernia surgeries.
详细描述
There will be three randomized groups: Group Control (no any block, n=30) Group M-TAPA (n=30), Group TAP (n=30). All patients will have standard general anesthesia. Group M-TAPA patients will receive bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml). Group TAP patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml). All blocks will be performed at the end of the surgery, before awakening the patients. All patients in the study will receive 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. All patients will have ibuprofen 3x400 mg in postoperative 24 hours (maximum dose 1200 mg/day). Numerical rating scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol will be administered as a rescue analgesic in all patients.Total tramadol consumption will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients older than 18 years of age who will undergo laparoscopic inguinal hernia under general anesthesia and will be American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
排除标准
- •Patients who did not give consent,
- •patients with coagulopathy,
- •patients with signs of infection at the block application site,
- •patients using anticoagulants,
- •patients with local anesthetic drug allergies,
- •patients undergoing open surgery,
- •patients with unstable hemodynamics,
- •patients who could not cooperate during postoperative pain assessment
研究组 & 干预措施
CONTROL
Control group patients are not going to be subjected to any block or local infiltration anesthesia. Their postoperative pain will be relieved with ibuprofen and tramadol (intravenous) administrations.
M-TAPA
Patients will have bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.
干预措施: M-TAPA block with bupivacaine 25% (Other)
TAP
Patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.
干预措施: TAP block with bupivacaine 25% (Other)
结局指标
主要结局
Comparing the numerical rating scale scores
时间窗: Postoperative 24 hours
Numerical rating scale will be used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
次要结局
- Comparing total tramadol consumption(Postoperative 24 hours)
研究者
Oguz Gundogdu
Associate Professor
Cumhuriyet University