Acupuncture for prevention of itch in Caesarean section V2
Research type
Research Study
Full title
Acupuncture for the prevention of intrathecal diamorphine-induced itch in elective caesarean section: a randomised controlled trial V2
IRAS ID
232541
Contact name
Tim Orr
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Research Summary:
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.
Lay summary of study results:
40 patients were recruited to the intervention group and 40 patients to the control group. Three participants in the intervention group were withdrawn (two for conversion to general anaesthesia and one was lost to follow up) and one participant from the control group was withdrawn (withdrawal of consent).24% of patients in the intervention group were itch free at 3-5 hours follow up compared to 18% in the intervention group. 24% of patients in the intervention group were itch free at 24 hours compared to 13% in the control group.
There was a trend to reduction in itch from acupuncture at the LI11 point compared to the TB10 point but this did not reach statistical significance.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
17/YH/0355
Date of REC Opinion
24 Nov 2017
REC opinion
Further Information Favourable Opinion