PruritusNCT03458572
Acupuncture for Prevention of Itch in Caesarean Section
A study testing Seirin Pyonex press needle acupuncture in people with Pruritus, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pruritus
- What is being tested?
- Seirin Pyonex press needle acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Feb 2018to 15 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA1-3 patients with uncomplicated pregnancies undergoing elective caesarean section with a plan for spinal anaesthesia with intrathecal diamorphine.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: Acupuncture for the Prevention of Intrathecal Diamorphine-induced Itch in Elective Caesarean Section: A Randomised Controlled Trial
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.
Read the 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
- Being tested
- Seirin Pyonex press needle acupuncture
- Keywords
- Caesarean section
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seirin Pyonex press needle acupunctureDevice
Acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 1.5mm Seirin Pyonex needle at LI11 point Receives: Device: Seirin Pyonex press needle acupuncture |
| Control | Sham comparator | 0.3mm Seirin Pyonex needle at TB10 point Receives: Device: Seirin Pyonex press needle acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of itch
Presence or absence of itch
Measured: between 3 and 5 hours post injection of spinal anaesthetic
Secondary outcomes (2)
Severity of itch on 11 point VAS scale
Severity of itch on 11 point VAS scale
Measured: between 3 and 5 hours post injection of spinal anaesthetic
Severity of worst overall itch on 11 point VAS scale
Severity of worst overall itch on 11 point VAS scale
Measured: At a follow up visit the next day following the spinal anaesthetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start12 Feb 2018
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Obstetric Anaesthetists' Association United Kingdom
- Responsible party
- Sponsor
- Investigators
- Tim Orr, Dr, Principal investigator, Trainee Anaesthesia (CT1-ST6)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458572
- Sponsor's protocol ID
- STH20078
- Status last verified
- May 2025
- First submitted
- 22 Feb 2018
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for the Prevention of Intrathecal Diamorphine-induced Itch in Elective Caesarean Section: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03458572
- Acronym / sponsor ID
- STH20078
- Conditions
- Pruritus
- Keywords
- Caesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Obstetric Anaesthetists' Association United Kingdom
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Seirin Pyonex press needle acupuncture1.5mm Seirin Pyonex needle at LI11 point |
| Control | Sham comparator | Device: Seirin Pyonex press needle acupuncture0.3mm Seirin Pyonex needle at TB10 point |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA1-3 patients with uncomplicated pregnancies undergoing elective caesarean section with a plan for spinal anaesthesia with intrathecal diamorphine.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seirin Pyonex press needle acupunctureAcupuncture | Device | Control, Intervention |
Primary outcome
Presence or absence of itch
Time frame: between 3 and 5 hours post injection of spinal anaesthetic
Presence or absence of itch
2 secondary outcomes
Severity of itch on 11 point VAS scale
Time frame: between 3 and 5 hours post injection of spinal anaesthetic
Severity of worst overall itch on 11 point VAS scale
Time frame: At a follow up visit the next day following the spinal anaesthetic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Orr, Dr principal investigator
Trainee Anaesthesia (CT1-ST6)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seirin Pyonex press needle acupuncture in people with Pruritus, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of itch (time frame: between 3 and 5 hours post injection of spinal anaesthetic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.