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

This study has been completed.
Sponsor:
Information provided by:
Letterkenny General Hospital
ClinicalTrials.gov Identifier:
NCT01283477
First received: January 24, 2011
Last updated: March 26, 2012
Last verified: January 2011
  Purpose

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 Intervention
Acupuncture
Morphine Induced Pruritis
Device: ACUPUNCTURE AT LI11
Device: SHAM ACUPUNCTURE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Acupuncture for Prophylaxis of Intrathecal Morphine Induced Pruritis in Patients Undergoing Caesarean Delivery

Resource links provided by NLM:


Further study details as provided by Letterkenny General Hospital:

Primary Outcome Measures:
  • Incidence of pruritis [ Time Frame: First 24 hr post intrathecal morphine ] [ Designated as safety issue: No ]
    To determine acupuncture at li 11 reduces the incidence of pruritis after elective caesarean delivery under spinal anaesthesia with intrathecal morphine


Secondary Outcome Measures:
  • Severity of pruritis [ Time Frame: 1, 4, 8, 24 hr post intrathecal morphine ] [ Designated as safety issue: No ]

    To determine acupuncture reduces:

    1. Severity of pruritis
    2. Requirement of relief medications


Enrollment: 44
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: January 24, 2011
Last Updated: March 26, 2012
Health Authority: Ireland: Medical Ethics Research Committee

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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 16, 2014