Effect of IV dexamethasone on the duration of spinal anesthesia administered with 0.5% hyperbaric bupivacaine and morphine in elective lower segment caesarean section – Double-blind randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- VAS SCORE
研究概览
简要总结
This double blinded randomized control study, led by Dr. Anusha B, aims to evaluate the efficacy of intravenous Dexamethasone in prolonging the duration of postoperative analgesia in elective Lower section Caesarean section under spinal anaesthesia with Inj. 0.5% hyperbaric bupivacaine 2.2 ml and 100 mcg of Inj. Morphine given intrathecally. The primary objective is to assess the effect of single dose IV Dexamethasone 8 mg on prolonging the duration of post-operative analgesia in LSCS under spinal anaesthesia using VAS score immediately on receiving in PACU and then at 15 min intervals till 4 hours and at 5, 6, 12, 24 hours post-operatively. This study enrols 62 pregnant females undergoing elective LSCS under spinal anaesthesia. After thorough preanesthetic check-up of all patients including all routine investigations, written consent shall be obtained. Randomization is done and Group -A will receive Inj. Dexamethasone 8 mg (2 ml) given IV, while Group - B which is the Control group will receive 2 ml 0.9% normal saline IV. Post operatively both groups are compared for Duration of post operative analgesia assessed by Visual Analog Scale score, time required for first rescue analgesic, duration of sensory block, duration of motor block duration using Modified Bromage Scale grading, assessment of Hemodynamic parameters, Total administered analgesics in 24 hrs, Incidence of PONV (post operative nausea and vomiting), Incidence of post operative shivering, Incidence of complications, if present. The statistical analysis will be conducted using SPSS software version 30.0. Statistical tests will be done by independent ‘t’-test and chi-square test according to the parameters considering p-value < 0.05 statistically significant. The study is done at Mehta Multi Speciality Hospitals, Chetpet, Chennai.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Category : Term Pregnant females
- •ASA PS : Grade II
- •Patients undergoing elective LSCS under spinal anaesthesia.
- •Patients who have given valid informed consent.
- •Patients who are able to rate their pain with good GCS and Normal mental status.
排除标准
- •Patient refusal
- •Patients with severe hypovolemia or hemodynamically unstable
- •Patients with Bleeding Diathesis or coagulation abnormalities
- •Severe pre-eclampsia
- •Eclampsia
- •Gestational diabetes mellitus
- •Ht less than 140cm or more than 180cm
- •BMI more than 30
- •Fetal distress
- •Cord prolapse
- •Infection at the probable site of Spinal anaesthesia
- •Spine deformity
- •Active labour
- •Cardiac or neurological disease
- •Failed spinal changed to GA
- •History of Allergy to Dexamethasone.
结局指标
主要结局
VAS SCORE
时间窗: immediately post operatively and then at 15 min intervals till 4 hours and at 5, 6, 12, 24 hours post-operatively
次要结局
- 1. Assessing duration of sensory block using pinprick(2. Assessing duration of motor block duration using Modified Bromage Scale grading)
- 4. Incidence of PONV (post operative nausea and vomiting)(5. Incidence of post-operative shivering)
- 7.Rescue post-operative analgesia(Post operatively the first time patient feels pain)
- 8. Total administered analgesics(At the end of 24 hrs post operatively)
研究者
Dr Anusha B
Mehta Multispeciality Hospital, CHETPET, CHENNAI
