Efficacy of Acupuncture for Prophylaxis of Intrathecal Mo... | NCT01283477

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

NCT01283477

Sponsor

Letterkenny General Hospital

Status

Completed

Last Update Posted

Mar 27, 2012Estimated

Enrollment

44Actual

Phase

Not Applicable

Conditions

Acupuncture
Morphine Induced Pruritis

Interventions

ACUPUNCTURE AT LI11
SHAM ACUPUNCTURE

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jan 24, 2011

First Submission Date that Met QC Criteria

Jan 25, 2011

First Posted Date

Jan 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2012

Last Update Posted Date

Mar 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACUPUNCTURE	Experimental		Device: ACUPUNCTURE AT LI11
SHAM ACUPUNCTURE	Sham Comparator		Device: SHAM ACUPUNCTURE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACUPUNCTURE AT LI11	Device	ACUPUNCTURE AT LI11 FOR 30 MINUTES PRIOR TO INTRATHECAL MORPHINE & LEFT IN PLACE FOR 30 MINUTES	ACUPUNCTURE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Severity of pruritis	To determine acupuncture reduces: Severity of pruritis Requirement of relief medications	1, 4, 8, 24 hr post intrathecal morphine

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
KARTHIK G RAMAMOORTHY, MBBS, DA,DAc,FCARCSI	Letterkenny General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Letterkenny General Hospital		Letterkenny	Donegal	999	Ireland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20131040	Background	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.
15985509	Background

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012877	Skin Manifestations
D012816	Signs and Symptoms