Clinical trial NCT03458572: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pruritus
Keywords: Caesarean section
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Obstetric Anaesthetists' Association United Kingdom
First posted: 2018-03-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Presence or absence of itch
timeFrame: between 3 and 5 hours post injection of spinal anaesthetic
Secondary outcomes:
measure: Severity of itch on 11 point VAS scale
timeFrame: between 3 and 5 hours post injection of spinal anaesthetic
measure: Severity of worst overall itch on 11 point VAS scale
timeFrame: At a follow up visit the next day following the spinal anaesthetic
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
Study officials:
affiliation: Trainee Anaesthesia (CT1-ST6)
name: Tim Orr, Dr
role: PRINCIPAL_INVESTIGATOR
References: