NCT03458572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

February 22, 2018

Last Update Submit

May 30, 2025

Conditions

Pruritus

Keywords

Caesarean section

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of itch

    Presence or absence of itch

    between 3 and 5 hours post injection of spinal anaesthetic

Secondary Outcomes (2)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

1.5mm Seirin Pyonex needle at LI11 point

Device: Seirin Pyonex press needle acupuncture

Control

SHAM COMPARATOR

0.3mm Seirin Pyonex needle at TB10 point

Device: Seirin Pyonex press needle acupuncture

Interventions

Seirin Pyonex press needle acupunctureDEVICE

Acupuncture

ControlIntervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tim Orr, Dr

    Trainee Anaesthesia (CT1-ST6)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 8, 2018

Study Start

February 12, 2018

Primary Completion

November 15, 2018

Study Completion

November 15, 2018

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)