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临床试验/NCT03458572
NCT03458572已完成不适用

Acupuncture for the Prevention of Intrathecal Diamorphine-induced Itch in Elective Caesarean Section: A Randomised Controlled Trial

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年2月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Presence or absence of itch

研究概览

简要总结

This study aims to determine the effectiveness of using a commercially available acupuncture stud at the LI11 acupuncture point at reducing the severity of itch caused by intrathecal diamorphine in elective caesarean section.

详细描述

Itch is a very common complication of diamorphine used in spinal anaesthesia for caesarean section with a local incidence of 78%. It ranges from irritating to distressing and difficult to treat and can adversely affect maternal satisfaction, wellbeing and bonding with their baby.

This trial aims to determine whether acupuncture using a commercially-available acupuncture stud at the LI11 point reduces the incidence and severity of post-operative itching in patients undergoing elective caesarean section under spinal anaesthesia with intrathecal diamorphine.

80 women having a planned caesarean section under spinal anaesthesia will be recruited by informed consent and randomised to the intervention group or the control group. The intervention group will receive an acupuncture stud at the LI11 point on either arm and the control group will receive acupuncture with a similar stud containing a smaller needle at a non-acupuncture point on either arm. The stud can be left in-situ until the followup visit the following morning or removed earlier at the participants discretion. All other care will be the usual clinical care including access to anti-itching drugs as required. Participants will be visited by a member of the research team at 3-5 hours following the start of their spinal anaesthetic and asked to mark their itch on an 11 point visual analogue scale (VAS). They will also be visited by a member of the research team the following morning, asked to rate their worst itch on the same scale and asked how troublesome they have found their itch (none, mild, moderate, severe). The administration of any anti-itch drugs will be recorded and if the acupuncture stud has not been removed it will be removed at this time.

If effective, acupuncture with an acupuncture stud would provide an acceptable, convenient, safe and cost-effective treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

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

  • ASA1-3 patients with uncomplicated pregnancies undergoing elective caesarean section with a plan for spinal anaesthesia with intrathecal diamorphine.

排除标准

  • Age under
  • Pre-existing itch or conditions associated with itch (eg cholestasis of pregnancy).
  • Pre-existing use of H1 receptor antagonists, non-selective antihistamines or ursodeoxycholic acid.
  • Severe perioperative complication or fetal death.
  • Conversion to general anaesthesia.
  • Unable to understand written and spoken English.

研究组 & 干预措施

Intervention

Experimental

1.5mm Seirin Pyonex needle at LI11 point

干预措施: Seirin Pyonex press needle acupuncture (Device)

Control

Sham Comparator

0.3mm Seirin Pyonex needle at TB10 point

干预措施: Seirin Pyonex press needle acupuncture (Device)

结局指标

主要结局

Presence or absence of itch

时间窗: between 3 and 5 hours post injection of spinal anaesthetic

Presence or absence of itch

次要结局

  • Severity of itch on 11 point VAS scale(between 3 and 5 hours post injection of spinal anaesthetic)
  • Severity of worst overall itch on 11 point VAS scale(At a follow up visit the next day following the spinal anaesthetic)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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