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

Acupuncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283477
• Other study ID #: ITM - LI 11
• Status: Completed
• Phase: N/A
• First received: January 24, 2011
• Last updated: March 26, 2012
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2011
• Source: Letterkenny General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acupuncture
• Morphine Induced Pruritis
• Pruritus

Intervention

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

Locations

Country	Name	City	State
Ireland	Letterkenny General Hospital	Letterkenny	Donegal

Sponsors (1)

Lead Sponsor	Collaborator
Letterkenny General Hospital

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pruritis	To determine acupuncture at li 11 reduces the incidence of pruritis after elective caesarean delivery under spinal anaesthesia with intrathecal morphine	First 24 hr post intrathecal morphine	No
Secondary	Severity of pruritis	To determine acupuncture reduces: Severity of pruritis; Requirement of relief medications	1, 4, 8, 24 hr post intrathecal morphine	No