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Acupuncture for Prevention of Itch in Caesarean Section

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ClinicalTrials.gov Identifier: NCT03458572
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
Obstetric Anaesthetist's Association
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Pruritus Device: Seirin Pyonex press needle acupuncture Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Acupuncture for the Prevention of Intrathecal Diamorphine-induced Itch in Elective Caesarean Section: A Randomised Controlled Trial
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
1.5mm Seirin Pyonex needle at LI11 point
Device: Seirin Pyonex press needle acupuncture
Acupuncture

Sham Comparator: Control
0.3mm Seirin Pyonex needle at TB10 point
Device: Seirin Pyonex press needle acupuncture
Acupuncture




Primary Outcome Measures :
  1. Presence or absence of itch [ Time Frame: between 3 and 5 hours post injection of spinal anaesthetic ]
    Presence or absence of itch


Secondary Outcome Measures :
  1. Severity of itch on 11 point VAS scale [ Time Frame: between 3 and 5 hours post injection of spinal anaesthetic ]
    Severity of itch on 11 point VAS scale

  2. Severity of worst overall itch on 11 point VAS scale [ Time Frame: At a follow up visit the next day following the spinal anaesthetic ]
    Severity of worst overall itch on 11 point VAS scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458572


Contacts
Contact: Tim Orr, Dr +44 (0)114 226 5940 tim.orr@sth.nhs.uk
Contact: Mel Woolnough, Dr melanie.woolnough@sth.nhs.uk

Locations
United Kingdom
Royal Hallamshire Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Contact: Tim Orr    +44 (0)114 226 5940    tim.orr@sth.nhs.uk   
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Obstetric Anaesthetist's Association
Investigators
Principal Investigator: Tim Orr, Dr Trainee Anaesthesia (CT1-ST6)

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03458572     History of Changes
Other Study ID Numbers: STH20078
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Caesarean section

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms