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Acupuncture for Prevention of Itch in Caesarean Section | Recruiting
Acupuncture for Prevention of Itch ... | Recruiting
Acupuncture for Prevention of Itch in Caesarean Section

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Medical Conditions
  • Pruritus
Primary Contact Details
Tim Orr, Dr
+44 (0)114 226 5940
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT03458572
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
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.
Research Details
  • 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.
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Device : Seirin Pyonex press needle acupuncture

Study Arm Groups : Intervention, Control

Intervention Type
See Interventions above
Primary Outcome Measures
    Presence or absence of itch; between 3 and 5 hours post injection of spinal anaesthetic
Secondary Outcome Measures
    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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
18 Years - N/A
Who Can Participate
Sorry, this information is not available
Number of Participants
80
Participant Inclusion Criteria
    Inclusion Criteria:

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

    Exclusion Criteria:

    - Age under 18.

    - 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Sheffield
South Yorkshire
S10 2JF
Trial Contact(s)
Primary Trial Contact
Tim Orr, Dr
+44 (0)114 226 5940
Other Trial Contacts
Mel Woolnough, Dr
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Acupuncture for the Prevention of Intrathecal Diamorphine-induced Itch in Elective Caesarean Section: A Randomised Controlled Trial
EudraCT Number
Not available for this trial
Funder(s)
  • Obstetric Anaesthetist's Association
Other Study ID Numbers
STH20078
Sponsor(s)
Sheffield Teaching Hospitals NHS Foundation Trust
Key Dates

Recruitment Start Date

Feb 2018

Recruitment End Date

Dec 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

22 Feb 2018

Date updated in source

07 Mar 2018