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Acupuncture for Prevention of Itch in Caesarean Section

Primary Purpose

Pruritus

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Seirin Pyonex press needle acupuncture
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pruritus focused on measuring Caesarean section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention

Control

Arm Description

1.5mm Seirin Pyonex needle at LI11 point

0.3mm Seirin Pyonex needle at TB10 point

Outcomes

Primary Outcome Measures

Presence or absence of itch
Presence or absence of itch

Secondary Outcome Measures

Severity of itch on 11 point VAS scale
Severity of itch on 11 point VAS scale
Severity of worst overall itch on 11 point VAS scale
Severity of worst overall itch on 11 point VAS scale

Full Information

First Posted
February 22, 2018
Last Updated
August 20, 2019
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Obstetric Anaesthetist's Association
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1. Study Identification

Unique Protocol Identification Number
NCT03458572
Brief Title
Acupuncture for Prevention of Itch in Caesarean Section
Official Title
Acupuncture for the Prevention of Intrathecal Diamorphine-induced Itch in Elective Caesarean Section: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
November 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Obstetric Anaesthetist's Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
Keywords
Caesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
1.5mm Seirin Pyonex needle at LI11 point
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
0.3mm Seirin Pyonex needle at TB10 point
Intervention Type
Device
Intervention Name(s)
Seirin Pyonex press needle acupuncture
Intervention Description
Acupuncture
Primary Outcome Measure Information:
Title
Presence or absence of itch
Description
Presence or absence of itch
Time Frame
between 3 and 5 hours post injection of spinal anaesthetic
Secondary Outcome Measure Information:
Title
Severity of itch on 11 point VAS scale
Description
Severity of itch on 11 point VAS scale
Time Frame
between 3 and 5 hours post injection of spinal anaesthetic
Title
Severity of worst overall itch on 11 point VAS scale
Description
Severity of worst overall itch on 11 point VAS scale
Time Frame
At a follow up visit the next day following the spinal anaesthetic

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Orr, Dr
Organizational Affiliation
Trainee Anaesthesia (CT1-ST6)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acupuncture for Prevention of Itch in Caesarean Section

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