The Analgesic Effects of Intrathecal Morphine in Comparison to Ultrasound-guided Transversus Abdominis Plane Block After Cesarean Section: a Randomized Controlled Trial at a Ugandan Regional Referral Hospital
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 主要终点
- Pain measurement
研究概览
简要总结
Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and relatively little data have been published about post-operative maternal pain control in these settings. Cesarean section is the most common type of major operation at our institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward staffing capacity is low, with much basic nursing care provided by families and friends of patients. The investigators conducted a study to examine the impact of ITM versus TAP block in a setting of limited formal nursing oversight.
详细描述
Intrathecal morphine (ITM), administered as a part of spinal anesthesia for caesarian section, can produce significant post-operative analgesia for several hours. The Tranversus Abdominis Plane (TAP) Block can also provide prolonged post-operative pain control. A small number of published studies comparing analgesic outcomes after cesarian section with ITM or TAP block have reported variable results.Moreover, these studies have been conducted in countries with extensive post-operative nursing care.
Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and relatively little data have been published about post-operative maternal pain control in these settings. Cesarean section is the most common type of major operation at our institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward staffing capacity is low, with much basic nursing care provided by families and friends of patients. The investigators conducted a study to examine the impact of ITM versus TAP block in a setting of limited formal nursing oversight.
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
- Single (Participant)
盲法说明
The subjects were randomly assigned to a study group (intrathecal morphine - ITM group - or TAP - TAP group) by a computer random number generator. Patients were blinded to their study allocation. Those in the ITM group were given 100 micrograms of preservative-free morphine in addition to the local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia. The TAP group were given only local anaesthesia (plain hyperbaric bupivacaine 10 mgs) during the spinal anaesthesia.
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
- •Women between the age of 18-45;
- •Greater than 50 kilograms in weight;
- •Routine spinal anesthetic without sedation for an uncomplicated caesarean delivery via a low, transverse abdominal incision (Pfannenstiel);
- •In good health with no major medical problems including gastric ulcers, liver or renal dysfunction
- •Able to communicate freely with a provided non-family member interpreter fluent in the patient's language so that informed consent may be obtained
排除标准
- •Patients with allergies to bupivacaine, paracetamol, or diclofenac;
- •Patients undergoing a surgical approach is other than a low, transverse abdominal incision (Pfannenstiel);
- •Pre-eclampsia, uterine rupture, placental abruption with this pregnancy;
- •Prior complicated abdominal surgery;
- •Medical history of gastric ulcers, liver or kidney dysfunction; and
- •Patient refusal to be involved in the study. Failure to attain informed consent from the patient due to age or level of consciousness
- •Voluntary or involuntary withdraw from the study
- •Referral to another health centre or Hospital for further management.
研究组 & 干预措施
Intervention
ITM group were given
- Local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia
- 100 micrograms of preservative-free morphine.
干预措施: Intrathecal morphine (Drug)
Control
TAP group were given only local anaesthesia (plain hyperbaric bupivacaine 10 mgs) during the spinal anaesthesia.
干预措施: Intrathecal morphine (Drug)
结局指标
主要结局
Pain measurement
时间窗: at 24 hours after intervention
Pain measurement using the numerical rating scale (NRS)
次要结局
未报告次要终点