CTRI/2025/05/086095尚未招募4 期
Magnesium sulphate vs Dexamethasone as an adjuvant to ropivacaine in ultrasound guided transverse abdominis plane block as post operative analgesia in lower segment cesarean section patients.A randomised clinical comparative study.
Institue of medical science and sum hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月15日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the duration of analgesia of dexamethasone and magnesium sulphate as an adjuvant to 0.2% ropivacaine in Ultrasound Guided Transverse Abdominus Plane Block in Lower segment caesarean patients
研究概览
简要总结
- The study is a randomized, double blinded, clinical comparative study will be conducted at our institution in obstetrics operations theatre with a study population of 100 patients.
- All the data collected will be entered in Microsoft excel 2007 and further analyses in SPSS version-27.categorised variables will be expressed in numericals and percentage.continuous variable will be expressed by chi-square /fischer extract test.comparison between two means will be assessed by using T test /mann Whitney.
- P value < 0.05 will be constant.
- Sample size-100
- Consent for Transverse abdominis plane block will be taken from each patient prior to their elective surgery and will be randomized into two groups 50 in each.
- All the patients will be nill per oral fast for at least 6 hours prior to the procedure.
- All the routine monitors will be attached and the preoperative baseline readings of noninvasive blood pressure, (NIBP), pulse rate (PR), and saturation (SPO2) will be noted.
- After securing an intravenous access using an 18-Gauge IV cannula all patients irrespective of the group they belonged to will be preloaded with Ringer’s lactate 10 mL/kg over 15 min.
- All patients will be administered spinal anesthesia with 0.5% hyperbaric bupivacaine of 2.2 -2.5ml using 25G Quincke’s needle in sitting position under strict aseptic precautions.
- Bilateral ultrasound guided posterior TAP block will be administered postoperatively immediately following surgery , drugs will be prepared by the attending anesthesiologist supervising the block and given unlabeled to the anesthesiologist who completed the block .
- A linear transducer is placed in the axial plane in the mid-axillary line and moved posteriorly to the most posterior limit of the TAP between the internal oblique and transversus abdominis muscles.
- The needle will be inserted in the mid-axillary line and advanced posteriorly until it reaches the posterior end of the TAP where local anesthetic will be injected.
- The in-plane technique with a 22G 80mm block needle will be used to inject 20 ml of 0.2% Ropivacaine combined with either 8 mg dexamethasone or 250 mg magnesium sulphate into the transverse abdominus plane on each side, bilaterally will be administered.
- IV paracetamol 15mg/kg analgesics will be given at the end of the surgery.Patients will be shifted to postoperative ward for monitoring.Patient will be allowed to take orally 4 hrs after surgery.
- Pain scores using the visual analogue scale (VAS) will be assessed at 2,4,6,8,12, and 24- hours to determine the post-block pain Scores. Rescue drug Tramadol will be given intravenously 50 mg IV when pt have VAS >4.
- Hemodynamic parameters like noninvasive blood pressure, heart rate, saturation, will be monitored at—2,4,6,8,12,24 hrs along with Nausea, vomiting, bradycardia and respiratory depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients posted for elective Lower segment caesarean section without any other comorbidities and primigravida patients and patient within the age group of 18 to 40 years,Patients under ASA 1&2 ,Patients who have given informed consent to participate in the study.
排除标准
- •Patients refusal, with multiple gestations, emergency lower segment cesarean section and patients requiring general anaesthesia and Patients with known allergy or contraindication to Ropivacaine, Magnesium Sulphate or Dexamethasone,Patients with a history of chronic pain or on chronic analgesic therapy,Pre eclampsia patient who received magnesium sulphate therapy,Patients with coagulopathy or on anticoagulant therapy, chronic use of steroid therapy, Patients with infection at the injection site or generalized sepsis,Patients with a Body mass index more than 35,Patients with neurological or psychiatric disorders affecting pain perception or reporting,Patients with pregnancy related complications such as preeclampsia, eclampsia, diabetes mellitus , gestational diabetes, and who are unwilling or unable to comply with post-operative pain assessments,patients with renal, cardiovascular diseases,contraindication to subarachnoid block.
结局指标
主要结局
To evaluate the duration of analgesia of dexamethasone and magnesium sulphate as an adjuvant to 0.2% ropivacaine in Ultrasound Guided Transverse Abdominus Plane Block in Lower segment caesarean patients
时间窗: 2,4,6,8,12,24 hours
次要结局
- To evaluate the pain scores using a standardized pain scale Visual analogue score at various time intervals post operatively,To measure total doses of rescue analgesia intake in first 24 hours post operatively,To monitor hemodynamic variables-systolic blood pressure,Diastolic blood pressure,Mean arterial pressure,Heart rate,Saturation,To observe any side effects due to drugs
研究者
研究点 (1)
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