跳至主要内容
临床试验/NCT04259502
NCT04259502Unknown不适用

Comparison of Rhomboid Intercostal Block and Erector Spina Plan Block for Peri-operative Analgesia in Mastectomy

Kutahya Health Sciences University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Pain score

研究概览

简要总结

Effectiveness of erector spinae plane block for analgesia in breast surgery was documented in previous studies. Rhomboid intercostal block may be beneficial for analgesia in breast surgery. The aim of this study is to compare the peri-operative analgesic effect of rhomboid intercostal block with erector spinae plane block in mastectomy operation. This trial was designed as prospective randomized single-blind study. The included patients will be assigned into two groups: RIB-Group where the patients will receive ultrasound-guided rhomboid intercostal block and ESP-Group where the patients will receive ultrasound-guided erector spinae plane block prior to the operation. Primary outcome will be peri-operative pain scores and secondary outcomes will be peri-operative opioid consumption and peri-operative hemodynamic effect of these blocks.

详细描述

Postoperative analgesia in breast surgery is important in reducing morbidity and mortality. Intravenous or oral analgesics may be used for this purpose. Ultrasound-guided fascia plane blocks are used to provide effective analgesia in mastectomy operations. Effectiveness of erector spinae plane block for analgesia in breast surgery was documented in previous studies.

Rhomboid intercostal block may be beneficial for analgesia in breast surgery. Both blocks have the advantage of unilateral application in unilateral mastectomy operations. When administered pre-operatively, it also provides per-operative analgesia and may reduce per-operative opioid consumption. These blocks are applied under ultrasound-guidance with single injection. Since the site of injection is relatively superficial (between the back muscles and ribs) and applied under ultrasound-guidance, mechanical complications is expected to occur less. These low-cost blocks also may reduce the usage of high-cost and high-risk opioids after surgery. These blocks unilaterally anesthetize the nerves innervating the thoracic region and the axilla, thus providing effective per-operative and post-operative analgesia in mastectomy operations.

The aim of our study is to compare the rhomboid intercostal block with erector spina plane block in mastectomy in terms of intraoperative and postoperative analgesia in mastectomy operation. Our hypothesis is rhomboid intercostal block may reduce peri-operative pain as effective as or more effectively than erector spina plane block. Secondary hypothesis is rhomboid intercostal block may reduce peri-operative opioid consumption as effective as or more effectively than erector spina plane block. Thus, the study is defined as block technique comparison.

Eighty patients aged between 29-79 years who are planned mastectomy under general anesthesia will be included in the study. Patients with severe cardiac and respiratory disease, severe coagulation disorder, body mass index greater than 35, refusal of regional block and patients having local infection in block application area, contraindication of the standardized drugs in the study and patients with insufficient postoperative analgesia requiring more potent opioids will be excluded from the study.

The patients who meet the study criteria will be assigned into two groups by using computerized randomization. Patients who do not give consent will also be excluded from the study. All patients will be sedated with midazolam and fentanyl prior to block application. First group (RIB-Group) of patients will receive ultrasound-guided rhomboid intercostal block prior to the operation under sedation. Patients in the second group (ESP-Group) will receive ultrasound-guided erector spina plane block under sedation. Since both procedures will be performed from the same site, the study was considered as a single blind.

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
Double (Participant, Care Provider)

盲法说明

The two interventions will be performed at the same thoracic region using the same technique as so; there participant will be blinded to the study. The investigator who performs the intervention will be unblinded. The investigator who will follow up the patients and collect the postoperative pain data will be blinded.

入排标准

年龄范围
29 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are planned mastectomy under general anesthesia

排除标准

  • Patients with severe cardiac and respiratory disease
  • Severe coagulation disorder
  • Body mass index greater than 35 kg/m2
  • Refusal of regional block
  • Patients having local infection in block application area
  • Contraindication of the standardized drugs in the study
  • Insufficient postoperative analgesia requiring more potent opioids

结局指标

主要结局

Pain score

时间窗: Throughout post-operative course, up to 48 hours

Subjective pain score reported by the patient, assessed by a blinded investigator to the study; which is defined as the score in a scale between minimum value of zero and maximum value of 10 (higher scores mean a better outcome).

Peroperative Analgesia

时间窗: At the end of the operation

Fentanyl consumption

次要结局

  • Opioid consumption(48th postoperative hour)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Onur Balaban, MD

Asistan Professor, MD.

Kutahya Health Sciences University

研究点 (2)

Loading locations...

相似试验