AcupunctureNCT01283477
Efficacy of Acupuncture for Prophylaxis of Intrathecal Morphine Induced Pruritis in Patients Undergoing Caesarean Delivery
A study testing ACUPUNCTURE AT LI11 in people with Acupuncture and Morphine Induced Pruritis, run by Letterkenny General Hospital at 1 site in Ireland.
Trial summary
Intrathecal morphine is commonly used for pain relief in caesarean delivery. Side effects such as itch (pruritis) and nausea \& vomiting are common and have been shown to be the most common cause for dissatisfaction. The incidence of pruritis is 74% even with current available medications. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acupuncture, Morphine Induced Pruritis
- What is being tested?
- ACUPUNCTURE AT LI11
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2010to Jun 2011
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I \& II patients undergoing elective caesarean delivery under spinal with intrathecal morphine
Who cannot join
- Patient refusal
- ASA III \& IV patients
- Pre-existing pruritis
- Eczema
- Bleeding tendencies
- Known allergy to any of medications used
- Any contra indication to spinal anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Intrathecal morphine is commonly used for pain relief in caesarean delivery. Side effects such as itch (pruritis) and nausea \& vomiting are common and have been shown to be the most common cause for dissatisfaction. The incidence of pruritis is 74% even with current available medications. Acupuncture has been shown to be effective for morphine related side effects but has not been evaluated for prophylaxis of itch in pregnant population.
PRIMARY OBJECTIVE:
Acupuncture at LI 11 reduces the incidence of pruritis after elective caesarean section under spinal with intrathecal morphine
- Conditions
- Acupuncture, Morphine Induced Pruritis
- Being tested
- ACUPUNCTURE AT LI11, SHAM ACUPUNCTURE
- Keywords
- Caesarean Delivery, Pruritis, Intrathecal Morphine, Acupuncture At LI11
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACUPUNCTURE AT LI11Device
ACUPUNCTURE AT LI11 FOR 30 MINUTES PRIOR TO INTRATHECAL MORPHINE \& LEFT IN PLACE FOR 30 MINUTES
SHAM ACUPUNCTUREDevice
SHAM ACUPUNCTURE AT A POINT 2 CM LATERAL TO LI11 30 MINUTES PRIOR TO INTRATHECAL MORPHINE \& LEFT IN PLACE FOR 30 MINUTES
| Study group | Role | What they receive |
|---|---|---|
| ACUPUNCTURE | Experimental | Not described Receives: Device: ACUPUNCTURE AT LI11 |
| SHAM ACUPUNCTURE | Sham comparator | Not described Receives: Device: SHAM ACUPUNCTURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pruritis
To determine acupuncture at li 11 reduces the incidence of pruritis after elective caesarean delivery under spinal anaesthesia with intrathecal morphine
Measured: First 24 hr post intrathecal morphine
Secondary outcomes (1)
Severity of pruritis
To determine acupuncture reduces:
- Severity of pruritis
- Requirement of relief medications
Measured: 1, 4, 8, 24 hr post intrathecal morphine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Letterkenny General Hospital
- Sponsor type
- Other government
- Investigators
- KARTHIK G RAMAMOORTHY, MBBS, DA,DAc,FCARCSI, Principal investigator, Letterkenny General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283477
- Sponsor's protocol ID
- ITM - LI 11
- Status last verified
- Jan 2011
- First submitted
- 24 Jan 2011
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jiang YH, Jiang W, Jiang LM, Lin GX, Yang H, Tan Y, Xiong WW. Clinical efficacy of acupuncture on the morphine-related side effects in patients undergoing spinal-epidural anesthesia and analgesia. Chin J Integr Med. 2010 Feb;16(1):71-4. doi: 10.1007/s11655-010-0070-7. Epub 2010 Feb 4.
PubMed 20131040Che-Yi C, Wen CY, Min-Tsung K, Chiu-Ching H. Acupuncture in haemodialysis patients at the Quchi (LI11) acupoint for refractory uraemic pruritus. Nephrol Dial Transplant. 2005 Sep;20(9):1912-5. doi: 10.1093/ndt/gfh955. Epub 2005 Jun 28.
PubMed 15985509Bonnet MP, Marret E, Josserand J, Mercier FJ. Effect of prophylactic 5-HT3 receptor antagonists on pruritus induced by neuraxial opioids: a quantitative systematic review. Br J Anaesth. 2008 Sep;101(3):311-9. doi: 10.1093/bja/aen202. Epub 2008 Jul 7.
PubMed 18611915
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture for Prophylaxis of Intrathecal Morphine Induced Pruritis in Patients Undergoing Caesarean Delivery
- ClinicalTrials.gov ID
- NCT01283477
- Acronym / sponsor ID
- ITM - LI 11
- Conditions
- Acupuncture, Morphine Induced Pruritis
- Keywords
- Caesarean Delivery, Pruritis, Intrathecal Morphine, Acupuncture At LI11
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Letterkenny General HospitalOther government
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Jan 2011 (estimated)
- 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.
Intrathecal morphine is commonly used for pain relief in caesarean delivery. Side effects such as itch (pruritis) and nausea \& vomiting are common and have been shown to be the most common cause for dissatisfaction. The incidence of pruritis is 74% even with current available medications. Acupuncture has been shown to be effective for morphine related side effects but has not been evaluated for prophylaxis of itch in pregnant population.
PRIMARY OBJECTIVE:
Acupuncture at LI 11 reduces the incidence of pruritis after elective caesarean section under spinal with intrathecal morphine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACUPUNCTURE | Experimental | Device: ACUPUNCTURE AT LI11 |
| SHAM ACUPUNCTURE | Sham comparator | Device: SHAM ACUPUNCTURE |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I \& II patients undergoing elective caesarean delivery under spinal with intrathecal morphine
Key exclusion criteria (7 listed)
- Patient refusal
- ASA III \& IV patients
- Pre-existing pruritis
- Eczema
- Bleeding tendencies
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 |
|---|---|---|
| ACUPUNCTURE AT LI11ACUPUNCTURE AT LI11 FOR 30 MINUTES PRIOR TO INTRATHECAL MORPHINE \& LEFT IN PLACE FOR 30 MINUTES | Device | ACUPUNCTURE |
| SHAM ACUPUNCTURESHAM ACUPUNCTURE AT A POINT 2 CM LATERAL TO LI11 30 MINUTES PRIOR TO INTRATHECAL MORPHINE \& LEFT IN PLACE FOR 30 MINUTES | Device | SHAM ACUPUNCTURE |
Primary outcome
Incidence of pruritis
Time frame: First 24 hr post intrathecal morphine
To determine acupuncture at li 11 reduces the incidence of pruritis after elective caesarean delivery under spinal anaesthesia with intrathecal morphine
1 secondary outcome
Severity of pruritis
Time frame: 1, 4, 8, 24 hr post intrathecal morphine
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 27 Mar 2012.
- Background: PubMed 20131040Jiang YH, Jiang W, Jiang LM, Lin GX, Yang H, Tan Y, Xiong WW. Clinical efficacy of acupuncture on the morphine-related side effects in patients undergoing spinal-epidural anesthesia and analgesia. Chin J Integr Med. 2010 Feb;16(1):71-4. doi: 10.1007/s11655-010-0070-7. Epub 2010 Feb 4.
- Background: PubMed 15985509Che-Yi C, Wen CY, Min-Tsung K, Chiu-Ching H. Acupuncture in haemodialysis patients at the Quchi (LI11) acupoint for refractory uraemic pruritus. Nephrol Dial Transplant. 2005 Sep;20(9):1912-5. doi: 10.1093/ndt/gfh955. Epub 2005 Jun 28.
- Background: PubMed 18611915Bonnet MP, Marret E, Josserand J, Mercier FJ. Effect of prophylactic 5-HT3 receptor antagonists on pruritus induced by neuraxial opioids: a quantitative systematic review. Br J Anaesth. 2008 Sep;101(3):311-9. doi: 10.1093/bja/aen202. Epub 2008 Jul 7.
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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.
KARTHIK G RAMAMOORTHY, MBBS, DA,DAc,FCARCSI principal investigator
Letterkenny General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACUPUNCTURE AT LI11 in people with Acupuncture and Morphine Induced Pruritis, run by Letterkenny General Hospital at 1 site in Ireland.
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 7 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 27 Mar 2012. 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 Ireland. 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?
Incidence of pruritis (time frame: First 24 hr post intrathecal morphine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01283477, which also lists 3 linked publications.
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 27 Mar 2012.