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

Primary Purpose

Acupuncture, Morphine Induced Pruritis

Status

Completed

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

ACUPUNCTURE AT LI11

SHAM ACUPUNCTURE

About this trial

This is an interventional prevention trial for Acupuncture focused on measuring Caesarean Delivery, Pruritis, Intrathecal Morphine, Acupuncture At LI11

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Letterkenny General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ACUPUNCTURE

SHAM ACUPUNCTURE

Arm Description

Outcomes

Primary Outcome Measures

Incidence of pruritis

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

To determine acupuncture reduces: Severity of pruritis Requirement of relief medications

Full Information

NCT ID

NCT01283477

First Posted

January 24, 2011

Last Updated

March 26, 2012

Sponsor

Letterkenny General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01283477

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Letterkenny General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acupuncture, Morphine Induced Pruritis

Keywords

Caesarean Delivery, Pruritis, Intrathecal Morphine, Acupuncture At LI11

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACUPUNCTURE

Arm Type

Experimental

Arm Title

SHAM ACUPUNCTURE

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

ACUPUNCTURE AT LI11

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

SHAM ACUPUNCTURE

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of pruritis

Description

To determine acupuncture at li 11 reduces the incidence of pruritis after elective caesarean delivery under spinal anaesthesia with intrathecal morphine

Time Frame

First 24 hr post intrathecal morphine

Secondary Outcome Measure Information:

Title

Severity of pruritis

Description

To determine acupuncture reduces: Severity of pruritis Requirement of relief medications

Time Frame

1, 4, 8, 24 hr post intrathecal morphine

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

KARTHIK G RAMAMOORTHY, MBBS, DA,DAc,FCARCSI

Organizational Affiliation

Letterkenny General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Letterkenny General Hospital

City

Letterkenny

State/Province

Donegal

ZIP/Postal Code

999

Country

Ireland

12. IPD Sharing Statement

Citations:

PubMed Identifier

20131040

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.

Results Reference

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PubMed Identifier

15985509

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. doi: 10.1093/ndt/gfh955. Epub 2005 Jun 28.

Results Reference

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PubMed Identifier

18611915

Citation

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.

Results Reference

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

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