Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Caesarean Section. A Double Blind, Randomized, Placebo Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Morphine consumption
研究概览
简要总结
ECS is a very common procedure. A 1-year retrospective survey revealed a vast opioid consumption among the new mothers of approximately (mean±SD) 35±25 mg of oral morphine in the first 24 postoperative hours despite a multimodal analgesic regimen. The adverse effects of morphine are well known and include postoperative nausea and vomiting (PONV), itching, fatigue, constipation, confusion, respiratory depression and delayed mobilization. These adverse effects are unsound for the new mothers as well as the breast-fed, newborn children. This study aims to evaluate the efficacy of bilateral Transmuscular Quadratus Lumborum (TQL) block in reducing postoperative morphine consumption and pain.
详细描述
Every year two hundred and twenty patients undergo elective caesarean section (CS) at the department of obstetric and gynaecologic surgery at Zealand University Hospital. The vast majority of these patients undergo the surgical procedure under spinal (subarachnoid) anaesthesia with Bupivacaine with the additive Sufentanil.
There are many ways to perform a caesarean section. The techniques can vary, regarding the type of skin incision, how the abdominal wall is dissected, how the uterine incision is made, and finally in which layers are closed after the procedure.
Two common transverse skin incisions are the Pfannenstiels incision and the Joel-Cohen incision. The Pfannenstiels incision is made 2 to 3 cm cephalad to the pubic bone, slightly curved so the midportion of the incision is within the shaved area of the pubic hair. The Joel-Cohen incision is placed 3 cm caudad to the anterior intercristal line; i.e. slightly more cephalad than the Pfannenstiels incision.
If the Pfannenstiels incision is utilized, the subcutaneous layer, fascia and the parietal peritoneum are usually dissected sharply, whereas with the Joel-Cohen incision, the subcutaneous layer is only incised medially, followed by a manual separation of the lateral tissue. The fascia and peritoneum are dissected bluntly.
At Zealand University Hospital, the skin incision used for elective caesarean sections is the Joel-Cohen incision. A straight, transverse, 12 cm long incision is made through the cutaneous layer as described above. The subcutaneous layer is incised only in the most medial area, through which two small incisions are made on each side of the midline of the fascia. These incisions in the fascia are then extended laterally with a scissor. The linea alba and parietal peritoneum are opened bluntly with the fingers. Finally, all the layers of the abdominal wall are pulled apart at the angles of the incisions, opening the incision laterally.
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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women scheduled for elective Caesarean Section in spinal anaesthesia.
- •Have received thorough information, orally and in written, and signed the "Informed Consent" form on participation in the trial
排除标准
- •Inability to cooperate
- •Inability to speak and understand Danish
- •Allergy to local anaesthetics or opioids
- •Daily intake of opioids
- •Local infection at the site of injection or systemic infection
- •Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
研究组 & 干预措施
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml ropivacaine 0,375% single shot.
In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
干预措施: Ropivacaine (Drug)
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml ropivacaine 0,375% single shot.
In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
干预措施: Acetaminophen (Drug)
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml ropivacaine 0,375% single shot.
In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
干预措施: Ibuprofen 400Mg Tablet / Celebra 100 Mg tablet (Drug)
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml ropivacaine 0,375% single shot.
In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
干预措施: ultrasound-guided nerve block (Device)
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml ropivacaine 0,375% single shot.
In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
干预措施: Morphine (Drug)
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml ropivacaine 0,375% single shot.
In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
干预措施: Patient-controlled analgesia (Device)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml saline single shot.
In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
干预措施: Saline (Drug)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml saline single shot.
In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
干预措施: Acetaminophen (Drug)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml saline single shot.
In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
干预措施: Ibuprofen 400Mg Tablet / Celebra 100 Mg tablet (Drug)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml saline single shot.
In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
干预措施: ultrasound-guided nerve block (Device)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml saline single shot.
In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
干预措施: Morphine (Drug)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml saline single shot.
In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
干预措施: Patient-controlled analgesia (Device)
结局指标
主要结局
Morphine consumption
时间窗: Twenty-four hours postoperatively
Data from PCA pump and patient medical record
次要结局
- The degree of morphine-related side effects. Nausea or PONV registered on CRF if any.(48 hours)
- Pain intensity (NRS 0-10/10)(At 6, 12, 24, 36, 48 hours postoperatively.)
- Total morphine consumption.(At 6, 12, 36 and 48 postoperative hours.)
- Patient satisfaction with application of the block. Satisfaction measured on NRS.(Immediately after application)
- Time from operation to ambulation(Within the first 24 postoperative hours)
- Duration of block(Time to first opioid within the first 24 postoperative hours.)