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OpenTrials
Completed

NCT Number: NCT01283477

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

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

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Key information

Conditions

Acupuncture Morphine Induced Pruritis Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Letterkenny General Hospital

Letterkenny, Donegal, 999, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACUPUNCTURE AT LI11

Device

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

Sham acupuncture

Device

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

Primary outcomes

  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 outcomes

  1. Severity of pruritis

    Time frame: 1, 4, 8, 24 hr post intrathecal morphine

    To determine acupuncture reduces:

    • Severity of pruritis
    • Requirement of relief medications

Sponsors and collaborators

Lead sponsor

Letterkenny General Hospital

Other Gov

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 26, 2011
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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