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

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ClinicalTrials.gov Identifier: NCT01283477
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : March 27, 2012
Sponsor:
Information provided by:
Letterkenny General Hospital

Brief 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. 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


Condition or disease Intervention/treatment Phase
Acupuncture Morphine Induced Pruritis Device: ACUPUNCTURE AT LI11 Device: SHAM ACUPUNCTURE Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Acupuncture for Prophylaxis of Intrathecal Morphine Induced Pruritis in Patients Undergoing Caesarean Delivery
Study Start Date : October 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: ACUPUNCTURE Device: ACUPUNCTURE AT LI11
ACUPUNCTURE AT LI11 FOR 30 MINUTES PRIOR TO INTRATHECAL MORPHINE & LEFT IN PLACE FOR 30 MINUTES
Sham Comparator: SHAM ACUPUNCTURE 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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Severity of pruritis [ Time Frame: 1, 4, 8, 24 hr post intrathecal morphine ]

    To determine acupuncture reduces:

    1. Severity of pruritis
    2. Requirement of relief medications



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283477


Locations
Ireland
Letterkenny General Hospital
Letterkenny, Donegal, Ireland, 999
Sponsors and Collaborators
Letterkenny General Hospital
Investigators
Principal Investigator: KARTHIK G RAMAMOORTHY, MBBS, DA,DAc,FCARCSI Letterkenny General Hospital

Publications:
Responsible Party: DR. KARTHIK GANESH RAMAMOORTHY , PRINCIPAL INVESTIGATOR, Letterkenny General Hospital, HSE IRELAND
ClinicalTrials.gov Identifier: NCT01283477     History of Changes
Other Study ID Numbers: ITM - LI 11
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: January 2011

Keywords provided by Letterkenny General Hospital:
Caesarean Delivery
Pruritis
Intrathecal Morphine
Acupuncture At LI11

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents