Quadratus Lumborum Block (QLB) for Pain Relief After Caesarean Section

赞助:

合作者:

信息的提供 (责任方):

Ruairi Irwin，Coombe Women and Infants University Hospital

追踪信息

首次提交日期 ^ICMJE

October 1, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

October 8, 2018

预计主要完成日期

May 1, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

IV PCA Morphine consumption up to 24 hours.[ Time Frame: 24 hours ]

Intravenous PCA (patient controlled analgesia) morphine consumption up to 24 hours.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Pain scores at rest.[ Time Frame: 6, 12, 24, 48 hours ]
VAS (visual analogue scale) pain scores at rest - lying supine in bed.
Pain scores on movement.[ Time Frame: 6, 12, 24, 48 hours ]
VAS pain scores on movement - raising head and shoulders off pillow when lying supine in bed.
Nausea and vomiting.[ Time Frame: 24, 48 hours ]
The incidence of N+V requiring rescue anti-emetics.
IV PCA morphine bolus demands.[ Time Frame: 24 hours ]
Intravenous PCA (patient controlled analgesia) morphine bolus demands up to 24 hours.
Total opioid consumption at 48 hours.[ Time Frame: 48 hours ]
Total opioid consumption at 48 hours - converted to IV morphine equivalents.
QbsQoR-11.[ Time Frame: 24, 48 hours ]
Quality of Recovery questionnaire.
QoR-15.[ Time Frame: 24, 48 hours ]
Quality of Recovery questionnaire.

描述性信息

简略标题 ^ICMJE

Quadratus Lumborum Block (QLB) for Pain Relief After Caesarean Section

正式标题 ^ICMJE

Quadratus Lumborum Block (QLB) for Pain Relief After Caesarean Section: A Prospective, Double-blind, Randomised Controlled Trial.

简要概况

There is currently a gap in the literature with regards to the utility of the QLB performed in conjunction with intrathecal morphine (ITM) for Caesarean section. The aim of the study is to assess the efficacy of the QLB as part of a multi-modal analgesic approach in patients after caesarean section.

详细说明

Post-operative pain relief management remains challenging after Caesarean-section. The perfect postoperative analgesic regimen is yet to be elucidated, but opioids remain a cornerstone whether they are administered intra-thecally, or systemically or both. Unfortunately, opioids are associated with significant adverse effects such as respiratory depression, post-operative nausea and vomiting (PONV), sedation and pruritus. Therefore, the search for opioid sparing analgesic techniques is important. The study treatment consists of a quadratus lumborum block (QLB) of either 0.25% Levobupivacaine or a simulated sham QLB after C-section under spinal anaesthesia. The participants will be randomized into one of two groups with an internet based randomisation tool, and then allocated to either group as per the allocation in a sealed opaque envelope. Spinal anaesthesia will be performed in a standardised manner using 10-15mg hyperbaric bupivacaine, 20ug fentanyl and 100ug preservative free morphine. Anaesthetic and surgical management will be conducted as per the usual manner. Diclofenac 100mg suppositories and IV Paracetamol 1g will be administered at the end of surgery. A Morphine PCA will be connected to the patient in the recovery room after the intervention. The bilateral posterior QLB will be performed after surgery in the supine position in an aseptic manner. The patient will be blinded to the group intervention as the sterile drapes will be left hanging blocking the patient's view of the procedure. The block from the spinal anaesthetic will mean the patient is unaware of the procedure being carried out. A curvilinear ultrasound probe will be used to identify the quadratus lumborum muscle. Intervention group: Aseptic, ultrasound guided, bilateral QLB using a posterior approach. This is known as the QLB 2 approach. A maximum volume of 20 ml of 0.25% Levobupivacaine will be administered each side. After the procedure a sterile dressing will be placed on the puncture site. Placebo group: The patient will be sterilized, draped and scanned in the same manner as the intervention group, until the target injection point is identified. The operator will use a blunt needle to apply pressure to the skin, (without breaking the skin), for one minute as if they are performing the procedure. This will be performed bilaterally. After the procedure, a sterile dressing will be placed over the pressure area.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Procedure: Quadratus lumborum block
Ultrasound guided Quadratus Lumborum block using a posterior approach. (QLB 2)
Procedure: Sham QLB
Sham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle.

研究工具

Active Comparator: Quadratus lumborum block
Bilateral posterior QLB with 20ml 0.25% L-Bupivacaine.
Sham Comparator: Sham QLB
Sham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle. Patient blinded due to residual spinal anaesthetic block.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

May 1, 2019

预计主要完成日期

May 1, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Elective Caesarean section under spinal anaesthesia. - Age > 18 years old. - Singleton pregnancy. Exclusion Criteria: - Contraindication to spinal or regional anaesthesia. - Allergy/sensitivity/contraindication to study medications. - Unable to comprehend visual analogue scale. - BMI > 40. - Booking weight <40kg. - History of chronic pain or regular opioid use. - Pre-eclampsia.

性别

参与研究的性别:

Female

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Ruairi Irwin，Coombe Women and Infants University Hospital

研究赞助商 ^ICMJE

Coombe Women and Infants University Hospital

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Terry Tan Head of Department of Anaesthesia CWIUH

PRS 账户

Coombe Women and Infants University Hospital

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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