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Acupuncture for Prevention of Itch in Caesarean Section

NHS Foundation Trust logo

NHS Foundation Trust

Status

Completed

Conditions

Pruritus

Treatments

Device: Seirin Pyonex press needle acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT03458572
STH20078

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Intervention
Experimental group
Description:
1.5mm Seirin Pyonex needle at LI11 point
Treatment:
Device: Seirin Pyonex press needle acupuncture
Control
Sham Comparator group
Description:
0.3mm Seirin Pyonex needle at TB10 point
Treatment:
Device: Seirin Pyonex press needle acupuncture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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