NCT01283477

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 27, 2012

Status Verified

January 1, 2011

Enrollment Period

8 months

First QC Date

January 24, 2011

Last Update Submit

March 26, 2012

Conditions

AcupunctureMorphine Induced Pruritis

Keywords

Caesarean DeliveryPruritisIntrathecal MorphineAcupuncture At LI11

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Severity of pruritis

    1, 4, 8, 24 hr post intrathecal morphine

Study Arms (2)

ACUPUNCTURE

EXPERIMENTAL
Device: ACUPUNCTURE AT LI11

SHAM ACUPUNCTURE

SHAM COMPARATOR
Device: SHAM ACUPUNCTURE

Interventions

ACUPUNCTURE AT LI11DEVICE

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

ACUPUNCTURE
SHAM ACUPUNCTUREDEVICE

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

SHAM ACUPUNCTURE

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I \& II patients undergoing elective caesarean delivery under spinal with intrathecal morphine

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Letterkenny General Hospital

Letterkenny, Donegal, 999, Ireland

Location

Related Publications (3)

  • 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.

    PMID: 20131040BACKGROUND

  • 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.

    PMID: 15985509BACKGROUND

  • 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.

    PMID: 18611915BACKGROUND

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • KARTHIK G RAMAMOORTHY, MBBS, DA,DAc,FCARCSI

    Letterkenny General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 24, 2011

First Posted

January 26, 2011

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 27, 2012

Record last verified: 2011-01

Locations

IE(1)