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临床试验/CTRI/2024/08/072236
CTRI/2024/08/072236尚未招募2/3 期

Comparative evaluation of ultrasound guided PECS block of the two concentration of levobupivacaine with adjuvant dexmedetomidine in patients undergoing modified radical mastectomy

Indira Gandhi Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Compare the efficacy of levobupivacaine 0.125% adjuvant (dexmedetomidine) with levobupivacaine 0.25% adjuvant (dexmedetomidine) in an ultrasound-guided PEC Block as analgesia during a 24-hr period after MRM.

研究概览

简要总结

Breast cancer is the most common cancer in the women worldwide. Mastectomy is the treatment of choice for carcinoma breast stage-I and -II with tumours not involving the chest-muscle fascia. Modified radical mastectomy (MRM) involves removal of the whole breast which includes the skin, areola, nipple, and most axillary lymph nodes. During mastectomy, some of the nerves in the chest are severed. Most women have some level of pain after the procedure. Severe acute postoperative pain following breast surgery not only increases the risk of persistent pain and affects recovery, it also leads to longer hospitalization and increased healthcare costs. Pectoral nerve block can provide a good analgesic effect for pain after carcinoma breast surgery. PECS blocks have also been proposed as alternative techniques to anesthetize operative regions such as the axilla, proximal medial upper arm, and posterior shoulder. In our study we are planning to give PECS block before induction of general anesthesia in two different concentration of levobupivacaine with adjuvant (dexmedetomidine).We will look which concentration of levobupivacaine with adjuvant (dexmedetomidine) will be better for postoperative analgesia .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 80.00 Year(s)(—)
性别
Female

入选标准

  • Age group in between 30 and 80 years, diagnosed with stage I and II breast carcinoma.
  • ASA I and II patients.
  • In patients whom consented for the procedure.
  • Patients with normal coagulation profile.

排除标准

  • Patient with chest wall / spine deformities.
  • Change in the procedure planed ; that is if initially the patient was planed for MRM later changed to more invasive procedure on table.

结局指标

主要结局

Compare the efficacy of levobupivacaine 0.125% adjuvant (dexmedetomidine) with levobupivacaine 0.25% adjuvant (dexmedetomidine) in an ultrasound-guided PEC Block as analgesia during a 24-hr period after MRM.

时间窗: 24 Hours

次要结局

  • To compare the requirement for rescue(analgesia in both groups)
  • Whether the PEC Block reduced the amount of analgesia used postoperatively.(24 hours)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr MANOJ KUMAR PANWAR

Professor at the department of anesthesiology, Indira Gandhi Medical College, Shimla.

研究点 (1)

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