Efficacy of Acupuncture for Prophylaxis of Intrathecal Morphine Induced Pruritis in Patients Undergoing Caesarean Delivery

NCT ID: NCT01283477

Last Updated: 2012-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Acupuncture Morphine Induced Pruritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ACUPUNCTURE

Group Type EXPERIMENTAL

ACUPUNCTURE AT LI11

Intervention Type DEVICE

ACUPUNCTURE AT LI11 FOR 30 MINUTES PRIOR TO INTRATHECAL MORPHINE \& LEFT IN PLACE FOR 30 MINUTES

SHAM ACUPUNCTURE

Group Type SHAM_COMPARATOR

SHAM ACUPUNCTURE

Intervention Type DEVICE

SHAM ACUPUNCTURE AT A POINT 2 CM LATERAL TO LI11 30 MINUTES PRIOR TO INTRATHECAL MORPHINE \& LEFT IN PLACE FOR 30 MINUTES

Interventions

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ACUPUNCTURE AT LI11

ACUPUNCTURE AT LI11 FOR 30 MINUTES PRIOR TO INTRATHECAL MORPHINE \& LEFT IN PLACE FOR 30 MINUTES

Intervention Type DEVICE

SHAM ACUPUNCTURE

SHAM ACUPUNCTURE AT A POINT 2 CM LATERAL TO LI11 30 MINUTES PRIOR TO INTRATHECAL MORPHINE \& LEFT IN PLACE FOR 30 MINUTES

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA I \& II patients undergoing elective caesarean delivery under spinal with intrathecal morphine

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Letterkenny General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Letterkenny General Hospital, HSE IRELAND

Principal Investigators

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KARTHIK G RAMAMOORTHY, MBBS, DA,DAc,FCARCSI

Role: PRINCIPAL_INVESTIGATOR

Letterkenny General Hospital

Locations

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Letterkenny General Hospital

Letterkenny, Donegal, Ireland

Site Status

Countries

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Ireland

References

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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.

Reference Type BACKGROUND
PMID: 20131040 (View on PubMed)

Che-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.

Reference Type BACKGROUND
PMID: 15985509 (View on PubMed)

Bonnet 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.

Reference Type BACKGROUND
PMID: 18611915 (View on PubMed)

Other Identifiers

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ITM - LI 11

Identifier Type: -

Identifier Source: org_study_id

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