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临床试验/CTRI/2020/03/024315
CTRI/2020/03/024315已完成不适用

To study the efficacy of ultrasound guided Quadratus Lumborum block for post operative analgesia after lower segment caesarean section:a randomised prospective controlled study

Dr Sandeep Sahu1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To study the efficacy of USG guided Quadratus lumborum block (USG-QL) in reducing pain (static and dynamic) after LSCS

研究概览

简要总结

As pain is ranked highest among undesirable clinical outcomes associated with caesarean section and it interferes with both mother and new born care ,so we are doing this study to see the role of levobupivacaine (which is used world wide for nerve blockade ) and efficacy in reducing post operative analgesia after caesarean section and we will also compare it with wound infiltration of same drug.Although IT and epidural morphine remain the most popular form of acute pain control for Caesarean pain, more than 70% of patients require additional analgesia. Furthermore, the sideeffect profile should not be underestimated; as many as 87% of patients experience pruritus and up to 70% experience urinary retention. Nausea and vomiting have also been well-established side effects, leading to significant discomfort for a new mother trying to provide acute infant care. Although nonsteroidal anti-inflammatory drugs and acetaminophen are helpful opioid-sparing multimodal adjuncts, the role of regional anaesthesia in improving Caesarean pain requires additional exploration. An IV PCA pump with demand dosing of opioids (fentanyl) provides effective pain relief after LSCS surgeries. However there are very limited studies on the assessment of analgesic efficacy and side effects of Quadratus lumborum block after caesarean section , as it confer major advantage over IVPCA alone because the regimen including background infusion increases total drug dosage and side effects without significantly improving analgesic efficacy. So, we designed a prospective, randomized study to evaluate the efficacy and side effects of quadratus lumborum block with levoboupivacaine in patients undergoing LSCS and taking patients with wound infiltration with same drug and as control group .We wish to compare between these two groups and conclude the best amongst the two. Following approval by the Institutional Ethics Committee, study would be completed in the period of 2 years. After taking written and informed consent from the patient, this study would be conducted in adult pregnant females with normal singleton pregnancy with a gestation of atleast 37 weeks undergoing lscs under spinal anaesthesia. Spinal anaesthesia will be administered with 27 G pencil tip needle, 2.0 ml heavy bupivacaine Patients will be immediately placed in supine position and spinal anaesthesia will be considered successful when a bilateral block to T6 , assessed by loss of cold(spirit swab) and touch (blunt pain ) discrimination will be established While in supine position ,patients will receive bilateral QLB at the end of surgrey .QLB will be performed under USG guidance using broad band (5-8MHz) convex probe .After cleaning abdomen with povidone iodine ,probe will be placed at ASIS and moved cranially until three abdominal wall muscles are clearly identified The needle will be inserted in plane from medial(anterior)to lateral (posterior).The optimal point of injection will be determined using hydrodissection . Assessment of pain will be done by a 11 point numerical rating scale (NRS); 0= no pain, 10 = worst imaginable pain.

Patients who met the inclusion criteria during the pre-anaesthetic check up will be randomly assigned into two equal groups of 30 each with the help of a computer generated table of random numbers; each group will receive post operative iv pca infusion with a solution containing 10 μg ml-1 fentanyl at a rate required by the patient.

QL BLOCK Group: USG guided QL block  with 0.25 % 20 -30ml levobupivacaine and IV Paracetamol 8 hourly, up to 24 hours postoperatively.

CONTROL Group:    wound infiltration with 0.25 % 20-30 ml levobupivacine  and IV Paracetamol , 8 hourly up to 24 hours postoperatively.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Adult female patients, ASA physical status I or II, with normal singleton pregnancy with a gestation of atleast 37 weeks who are scheduled for lower segment caesarean section under spinal anaesthesia will be included in the study.

排除标准

  • Patient refusal to partipate, coagulation disorders, signs of local or systemic infection, , patients with acute or chronic renal disease, spinal deformities, ASA grade 3 or 4 ,patients who used anticoagulants or were unable to comprehend or use the verbal rating pain scoring system or PCA pump .

结局指标

主要结局

To study the efficacy of USG guided Quadratus lumborum block (USG-QL) in reducing pain (static and dynamic) after LSCS

时间窗: At 0 (zero) hours,4 hours,8 hours,12 hours,16 hours,20 hours and finally 24 hours

次要结局

  • 1.Duration of analgesia in both groups,(2.Pain- by NRS score)

研究者

发起方
Dr Sandeep Sahu
申办方类型
Other [self]

研究点 (1)

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