Acupuncture for Prevention of Itch in Caesarean Section

NCT ID: NCT03458572

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-12
• Study Completion Date: 2018-11-15

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.

Conditions

Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

1.5mm Seirin Pyonex needle at LI11 point

Group Type: EXPERIMENTAL

Seirin Pyonex press needle acupuncture

Intervention Type: DEVICE

Acupuncture

Control

0.3mm Seirin Pyonex needle at TB10 point

Group Type: SHAM_COMPARATOR

Seirin Pyonex press needle acupuncture

Intervention Type: DEVICE

Acupuncture

Interventions

Seirin Pyonex press needle acupuncture

Acupuncture

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Obstetric Anaesthetists' Association United Kingdom

OTHER

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Orr, Dr

Role: PRINCIPAL_INVESTIGATOR

Trainee Anaesthesia (CT1-ST6)

Locations

Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

STH20078

Identifier Type: -

Identifier Source: org_study_id