Efficacy of Acupuncture for Prophylaxis of Intrathecal Morphine Induced Pruritis in Patients Undergoing Caesarean Delivery - Full Text View

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:

MedlinePlus related topics: Acupuncture Acute Bronchitis Cesarean Section Itching

Drug Information available for: Morphine sulfate

U.S. FDA Resources

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:

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. Epub 2010 Feb 4.

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. Epub 2005 Jun 28.

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. Epub 2008 Jul 7. Review.

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 May 16, 2013