跳至主要内容
临床试验/NCT02790099
NCT02790099已完成4 期

Double-blinded Randomized Controlled Study for Comparison of Surgical Rectus Sheath and Intrathecal Morphine for Postoperative Pain Control After Caesarean Section

Queen Mary Hospital, Hong Kong1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
144
试验地点
1
主要终点
Pain score

研究概览

简要总结

Pain is the main obstacle in delaying postoperative recovery and leads to prolonged hospital stay. Administration of intrathecal morphine during spinal anaesthesia can provide effective pain control. However, it is associated with significant side effects including nausea, vomiting and itchiness. Also, it is not suitable in all patients, for example, those with morphine allergy, or severe respiratory disease. Surgical rectus sheath block involves injection of local anaesthetic agents into the rectus sheath space before closure of the wound. It has been shown to provide adequate pain control with less systemic side effects. The aim of the study is to evaluate the effectiveness of surgical rectus sheath block and intrathecal morphine in post-Caesarean section pain control.

详细描述

The incidence of Caesarean section is increasing worldwide. Adequate post-operative analgesia is becoming an essential expectation of patients after Caesarean section. The process of recovery will be hindered by suboptimal pain control and eventually it will leads to immobilization and prolonged hospital stay.

Spinal anesthesia is usually the mode of anesthesia in pregnancy in view of increase general anesthetic risks. Intrathecal morphine can provide good pain control. However, pruritus can occur in up to 51% of patient, nausea and vomiting in up to 21%. Despite its significant side effects, there is an overall better patient satisfactory over use of intrathecal morphine. Due to its concern on respiratory depression, intrathecal morphine is not recommended in patients with severe respiratory disease, obstructive sleep apnoea or those receiving central nervous system depressants. As a result, there were numerous studies on alleviating the adverse effect and to search for other alternatives.

Rectus sheath block aims at blocking the terminal branches of 9th -12th intercostals nerve within the rectus sheath. They form rectus sheath plexus after piercing the posterior aspect of the rectus sheath and then branch into muscular and cutaneous branches. It can be given by anesthetist with or without ultrasound guidance. However, it involved additional time for administration of rectus sheath block and possibility of incorrect placement of catheter leading to ineffective analgesia.

On the contrary, surgical rectus sheath block was administrated by surgeon before closure of rectus sheath. It involves injection of local anesthetic in the rectus sheath space before closure of the wound under direct visual control. Surgical rectus sheath block was shown to be effective in postoperative pain control after transverse laparotomy in paediatrics patients. It was shown to be effective in postoperative pain control in Caesarean section without intrathecal morphine.

Surgical rectus sheath block may be a simple and safe alternative for intrathecal morphine. However, the evidence on its use in Obstetrics and Gynaecology was sparse and there is no study directly comparing the two different mode of analgesia. The aim of the study is to evaluate the use of surgical rectus sheath and intrathecal morphine for postoperative pain in Caesarean section; and its side effects profile.

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, Care Provider, 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

入选标准

  • Planned for elective lower segment Caesarean section, using suprapubic transverse incision
  • Willing and able to participate after the study has been explained
  • Those understand either Cantonese, Putonghua or English

排除标准

  • Patient with treatment for chronic pain
  • History of narcotic abuse/ recreational drug use
  • Allergy to opioids/ local anesthesia/ paracetamol/ tramadol/ non-steroidal anti-inflammatory drugs
  • Patient with pre-eclampsia

研究组 & 干预措施

Rectus sheath block only

Experimental

Patient will be given surgical rectus sheath block postoperatively with 40ml of bupivacaine (2.5mg/mL) and 0.1ml of normal saline will be injected intrathecally at time of spinal anaesthesia.

干预措施: Bupivacaine (Drug)

Intrathecal morphine group

Active Comparator

0.1mg preservative free morphine will be injected intrathecally at time of spinal anesthesia and 40ml of normal saline will be injected as rectus sheath block.

干预措施: Morphine (Drug)

Both intervention

Active Comparator

Patient will be given 0.1mg preservative free morphine intrathecally at time of spinal anaesthesia and surgical rectus sheath block with 40ml of bupivacaine (2.5mg/ml).

干预措施: Bupivacaine (Drug)

Both intervention

Active Comparator

Patient will be given 0.1mg preservative free morphine intrathecally at time of spinal anaesthesia and surgical rectus sheath block with 40ml of bupivacaine (2.5mg/ml).

干预措施: Morphine (Drug)

结局指标

主要结局

Pain score

时间窗: at 12 hours postoperatively

Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)

次要结局

  • Side effect(3days postoperatively)
  • Requirement of oral analgesics(within 24hours postoperatively)
  • Time of mobilization(3days postoperatively)
  • Pain score(24hrs postoperatively)

研究者

发起方
Queen Mary Hospital, Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lui Man Wa

Dr

Queen Mary Hospital, Hong Kong

研究点 (1)

Loading locations...

相似试验