Comparison of Postoperative Analgesia With Different Doses of Intrathecal Morphine With Hyperbaric Bupivacaine and Fentanyl in Cesarean Section Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- To compare the incidence of postoperative pain after cesarean section with different doses of intrathecal morphine with bupivacaine among the four groups.
研究概览
简要总结
Central neuraxial blocks (CNBs) remain the preferred anesthetic technique for cesarean section, with single shot spinal anesthesia (SSSA) being the standard practice at investigator's institute unless contraindicated. SSSA offers reliable intraoperative anesthesia and provides a few hours of postoperative analgesia. Enhanced recovery after cesarean section protocol has recommended the addition of intrathecal (IT) morphine to improve the postoperative quality of the recovery profile. Fentanyl improves the quality of intraoperative analgesia, while morphine significantly prolongs the postoperative pain relief, often lasting up to 24 hours.
Routine uterine exteriorization, practiced in all cases at investigator's institute, often results in peritoneal stretching pain during surgery. This visceral pain is managed with 10 mcg intrathecal fentanyl added to hyperbaric bupivacaine. For postoperative pain management, the intrathecal morphine is recommended by many guidelines and studies. Intrathecal morphine dose typically ranges from 50 to 300 mcg. The dose of morphine exceeding 150 mcg are usually associated with prolongation of analgesia with higher incidence of side effects like nausea, vomiting and pruritus. In selected cases, investigator had administered morphine 100-150 mcg and the clinical experience has shown reduced postoperative analgesic requirements and favorable recovery profile, with minimal adverse effects.
Despite these promising experiences and extensive literature on IT morphine, their is still lack formal data on the efficacy and safety profile of IT morphine in cesarean section patient. This comparative study will help institute to find the optimum dose of IT morphine with better postoperative analgesia quality with low side effects profile. The finding could serve as a foundation to promote routine use of intrathecal morphine in cesarean section anesthesia at investigator's institute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant lady > 36 weeks of gestation presenting for cesarean section under spinal anesthesia
- •ASA II/ III
- •Maternal Height > 150 cm
- •BMI< 40 Kg/m2
- •Elective Indication
排除标准
- •Patient unwilling to take part in the study
- •Patient with known allergy to the study medications
- •Contraindication to Spinal Anesthesia
研究组 & 干预措施
Group BF
Intrathecal drug used: 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml), total volume of 2.2ml, single administration, no repetition of intervention In this group, no dose of morphine will be added.
干预措施: 0.5% bupivacaine heavy with fentanyl (Drug)
Group BF-M50
Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml) plus morphine 50mcg (0.05ml) with total volume of 2.25ml single administration, no repetition of intervention
干预措施: 0.5% bupivacaine heavy with fentanyl plus morphine 50 mcg (Drug)
Group BF-M100
Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml) plus morphine 100mcg (0.1ml) with total volume of 2.3ml single administration, no repetition of intervention
干预措施: 0.5% bupivacaine heavy with fentanyl plus morphine100 mcg (Drug)
Group BF-M150
Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml) plus morphine 150mcg (0.15ml) with total volume of 2.35ml single administration, no repetition of intervention
干预措施: 0.5% bupivacaine heavy with fentanyl plus morphine 150mcg (Drug)
结局指标
主要结局
To compare the incidence of postoperative pain after cesarean section with different doses of intrathecal morphine with bupivacaine among the four groups.
时间窗: NRS score is measured in recovery room for postoperative pain assessment. This time will be recorded as "time zero". Then in postoperative ward, NRS score is measured at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours from 'time zero".
The parturient among study groups receiving different dose of intrathecal morphine with bupivacaine were compared for incidence of postoperative cesarean section pain. The pain is assessed by using Numerical Pain Rating Scale(NRS) ,a 11-point, standardized tool (0-10) in which 0 means "no pain" and 10 means "the worst pain imaginable". The number of parturient with NRS more than 3 will be compared for postoperative pain among the 4 groups.
次要结局
- To compare the first rescue analgesia demand time among the four groups(Postoperative period after cesarean delivery till 24 hour)
- To compare the total analgesic consumption in first 24 hours among the parturient of four group(Postoperative total analgesia consumption for first 24 hour)
- To compare the frequency of rescue analgesia demanded by parturient in first 24 hours among the groups(Postoperative period for first 24 hour)
- To compare the incidence of side effects like nausea, vomiting, respiratory depression, level of sedation and pruritus in first 24 hours among the groups(Postoperative period for first 24 hour)
研究者
Bashu Dev Parajuli
Dr
Tribhuvan University Teaching Hospital, Institute Of Medicine.