Ignite Creation Date:
2024-05-06 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03458572
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2018-02-22
Brief Title:
Acupuncture for Prevention of Itch in Caesarean Section
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
Acupuncture for the Prevention of Intrathecal Diamorphine-induced Itch in Elective Caesarean Section A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None