To compare the effect of Intrathecal Buprenorphine Versus Buprenorphine in the Transversus Abdominis Plane(TAP) Block on Post Operative Nausea and Vomiting among subjects under going elective Cesarean Section:A Randomised Comparitive Study”
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Assessment of incidence of post operative nausea and vomiting using likert scale in the first 24hours.
研究概览
简要总结
After obtaining approval and clearance from the institutional ethics committee, the parturients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent. (Annexure – 1). Parturients belonging to ASA Grade II (Annexure -2) will be chosen Parturients will be randomly assigned to two equal groups as Group 1 (spinal anaesthesia with intrathecal bupivacaine) and Group 2 (spinal anaesthesia with TAP block). A computergenerated random numbers will be used to allocate participation for each group using www.randomization.com The anaesthetic procedure will be standardized.The explanation regarding the procedure and post operative follow up will be done during the pre operative checkup.Once the parturient arrives to the recovery two 18G cannula will be secured.500ml ringer lactate solution or 0.9% normal saline is infused prior anaesthesia.Once Parturient gets shifted to OT all the standard monitors will be attached, baseline vitals will be noted.Then the parturients will be positioned into lateral position, under sterile aseptic precautions dural puncture will be done in L3-L4 intervertebral space using 25G Quincke’s babcock spinal needle and after ensuring the flow of csf Group 1 parturients will receive 1.8ml of 0.5% Hyperbaric Bupivacaine plus 0.2ml of Buprenorphine intrathecally and group 2 parturients will receive 1.8ml of 0.5% Hyperbaric Bupivacaine with 0.2ml of normal saline intrathecally. Hemodynamic parameters such as BP, HR spo2 will be monitored for every three minutes for the first 15minutes and every 5 minutes once the baby is extracted. Once the skin closure is done group 2 will receive ultrasound guided transversus abdominis plane block on each side with Inj burenorphine 60mcg.Parturients will be monitored for 10 minutes in the post operative anaesthesia care unit after cesarean section and will be shifted to the wards later. The parturients will be monitored post operatively for the incidence of post operative nausea and vomiting (PONV) in the first 24 hours. The observer will be blinded regarding the parturients. The primary outcome parameter will be the PONV incidence within 24hrs post operatively. The severity of post operative nausea and vomiting during this period will be assessed using likert scale (Annexure 3) from 0 to 10. PONV will be defined as vomiting,marked nausea [numerical rating scale (NRS>4)], and/or need for rescue medication.Parturients will be assessed for PONV at 0.2.4,12, and 24 hours using the likert scale. · Nausea and it’s severity, vomiting attacks,pain and it’s severity,need for additional analgesics,and administration of antiemetic rescue medications, drowsiness of the parturients(Annexure 4)will be evaluated as secondary parameters.The degree of nausea was evaluated using the visual analogue scale (VAS)(Annexure 5)with 0 indicating no nausea or vomiting and 10 indicating the most severe form of unbearable nausea or vomiting.When the PONV score was greater than 4 or when vomiting occurs 11 point numerical rating scale for pain (0= no pain and 10= worst possible pain )(Annexure 6)will be explained. In addition to this the rescue antiemetic requirement, number of additional antiemetic applications, rescue analgesic requirement and number of additional analgesic applications will also be Parturients will be monitored for 24 hours post operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Parturient willing to give informed consent Age between 18-45yrs Parturients posted for elective cesarean section Parturients with ASA grade II.
排除标准
- 未提供
结局指标
主要结局
Assessment of incidence of post operative nausea and vomiting using likert scale in the first 24hours.
时间窗: Immediate post operative to 24 hours
Assessment of severity of nausea using visual analogue scale (VAS) in first 24 hours
时间窗: Immediate post operative to 24 hours
Assessment of post operative pain using 11 point numerical scale in first 24 hours
时间窗: Immediate post operative to 24 hours
次要结局
- Duration of anesthesia (from the start of spinal anaesthesia to end of surgery)(Time for 1st rescue analgesia)
研究者
DR Kamalieshree M
Bangalore Medical College and RI
