Does Subarachnoid Administration of Hyperbaric Prilocaine Produce an Improved Recovery From Anaesthesia When Compared With Hyperbaric Bupivacaine When Used to Make Cervical Cerclage Easier in Pregnant Women at Risk of Pre-term Loss?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Time from SAB to Bromage score of I
研究概览
简要总结
Patients that have a "cervical stitch" (cervical cerclage) require an anaesthetic. The most common choice is a spinal block. This is an injection in the back that makes the lower half of the body become temporarily numb and weak. The key aims when choosing which type of anaesthetic are safety for mother and baby, comfort during and after the procedure as well as patient convenience and satisfaction. There are two commonly available choices for the drug used in spinal anaesthesia, bupivacaine and prilocaine. Both have a long history of being safe and effective. One difference observed in studies of these drugs used for spinal anaesthetics in other surgeries is that prilocaine is shorter-acting and it, therefore, takes less time for the return of full strength and sensation of the lower body. This means patients are able to leave hospital sooner and are less likely to need a urinary catheter. The investigators want to see if these benefits can apply to patients having a cervical stitch too, by comparing the recovery of patients having a spinal anaesthetic with one of these two local anaesthetic medications.
详细描述
Cervical incompetence is defined as the inability to sustain a pregnancy to full term. It is characterized by recurrent second-trimester pregnancy losses. Cervical cerclage is a procedure that is commonly carried out in order to prevent pre-term loss in at-risk pregnancies. The major challenge of performing this as a day case procedure is achieving adequate anaesthesia for comfortable performance of the cerclage whilst providing adequate regression of motor and sensory blocks to allow ambulation and bladder control within an appropriate timescale. Spinal anaesthesia, or subarachnoid block (SAB), is commonly employed to facilitate a wide variety of pelvic and lower limb surgeries. In the United Kingdom, the commonly administered subarachnoid agents are bupivacaine, prilocaine and, until recent decades, lidocaine. The duration of action of bupivacaine makes it less well suited to day surgery as it is often difficult to reach discharge criteria within a convenient time frame. The investigators aim to examine the recovery profiles of two equipotent doses of hyperbaric prilocaine and bupivacaine. Given the evidence, the survey of practice in other centres and the commonly used doses at this institution the following regimens will be compared:
- 40 mg of hyperbaric 2% prilocaine with 15 mcg of fentanyl (intervention) and
- 10 mg of hyperbaric 0.5% bupivacaine with 15 mcg of fentanyl (comparator).
Primary Objective:
This study aims to determine if a difference exists between the time required for regression of motor block between two commonly used and equipotent doses of subarachnoid hyperbaric prilocaine and bupivacaine.
- The hypothesis is that SAB with hyperbaric 2% prilocaine will result in a clinically significant reduction in time taken for regression of motor blockade, as determined by achieving a Bromage score* of I, when compared to an equipotent dose of hyperbaric bupivacaine when used to facilitate cervical cerclage in pregnant women in the second trimester of pregnancy.
- The null hypothesis is that no clinically significant difference exists while the alternative hypothesis is that such a difference truly exists.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy (ASA score 2 or 3) pregnant women presenting for elective cervical cerclage under SAB.
- •Age > 18 years
排除标准
- •Inability to read or understand the patient information sheet (PIS)
- •Age < 18 years
- •Unable or unwilling to consent to participation
- •non-elective procedure
- •serious co-morbidities (ASA score 4 or above)
- •any contraindication to SAB, e.g. local or generalised infection, active central nervous system disease, coagulation disorders or anti-coagulant medication
- •any history of allergic reaction to any of the medications in the protocol
- •concomitant use of class III anti-arrhythmics (sulfonamides, antimalarials, sodium nitroprussate, nitroglycerin, other local anaesthetics)
- •any contraindication to the use of bupivacaine or prilocaine as listed in the SmPCs.
研究组 & 干预措施
Prilocaine (Intervention) Group
Subarachnoid block (SAB) with 40 mg (2 ml) of hyperbaric 20 mg/ml prilocaine and 15 mcg (0.3 ml) fentanyl (50 mcg/ml)
干预措施: Prilocaine (Hyperbaric 2%) (Drug)
Bupivacaine (Control) Group
Subarachnoid block (SAB) with 10 mg (2 ml) of hyperbaric 5 mg/ml bupivacaine and 15 mcg (0.3 ml) fentanyl (50 mcg/ml)
干预措施: Bupivacaine (Hyperbaric 0.5%) (Drug)
结局指标
主要结局
Time from SAB to Bromage score of I
时间窗: 24 hours
Difference in time taken for regression of lower limb block between the two groups
次要结局
- Time from SAB until motor block Bromage IV(30 minutes)
- Degree of motor block(20 minutes)
- Maximum intraoperative Numerical Rating Score (NRS) [0-10](1 hour)
- Time from SAB until loss of cold sensation to ethyl chloride spray at tenth thoracic dermatomal level (T10)(30 minutes)
- Determine uppermost level of sensory block(20 minutes)
- Time from SAB to micturition(24 hours)
- Time from SAB to ambulation(24 hours)
- Time from SAB to discharge(24 hours)