NCT02523846

Brief Summary

The purpose of this study is to improve IV-Patient Controlled Analgesia (IV-PCA) technique for postoperative analgesia. Investigators are comparing between patient re-education and the background morphine infusion among patients who fail to achieve satisfactory analgesia using IV-PCA Morphine after laparotomy.

Trial Health

55
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Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

August 10, 2015

Last Update Submit

August 14, 2015

Conditions

Post-operative Pain

Keywords

IV-Patient Controlled Analgesia (IV-PCA)background morphine infusionpatient re-education

Outcome Measures

Primary Outcomes (1)

  • measure pain intensity at rest and when blowing incentive spirometer (dynamic pain)

    use combination of Numerical Rating Scale(NRS) and Visual Analogue Scale(VAS)

    48 hours after surgery

Secondary Outcomes (3)

  • respiratory rate

    48 hours after surgery

  • total accumulative morphine consumption from IV-PCA pump

    48 hours after surgery

  • sedation level

    48 hours after surgery

Study Arms (2)

Background morphine infusion to IV-PCA Morphine

ACTIVE COMPARATOR

Calculate based on patient's age, in mg/hour

Drug: morphineBehavioral: Patient re-education

Patient re-education to IV-PCA Morphine

EXPERIMENTAL

Using patient information leaflet

Behavioral: Patient re-education

Interventions

morphineDRUG

Investigators use the formula that was published by Pamela Macintyre in her paper entitled "Age is the Best Predictor of Postoperative Morphine Requirements." The estimation for the first 24-hour morphine requirement after surgery is calculated as: 100 - age (year). So, half of the total 24-hour morphine requirement will be infused over 24 hours. e.g. background morphine infusion= (100-Age)/ 2/ 24 (mg/hour)

Background morphine infusion to IV-PCA Morphine
Patient re-educationBEHAVIORAL

A similar leaflet will be used to re-educate patient at 4 hour after surgery. The correct method to initiate IV-PCA dose, possible side effects and addiction issue will be explained again and re-emphasized

Background morphine infusion to IV-PCA MorphinePatient re-education to IV-PCA Morphine

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA)Physical Status Classification Class I and II
  • Elective laparotomy
  • able to understand either malaysia, mandarin, english language or local dialect
  • patient with dynamic pain score 4/10 and more within the first 4-hour after initiation of IV-PCA

You may not qualify if:

  • patient refusal
  • laparotomy with pfannenstiel incision
  • patients with a history of allergy to opioids
  • patients who required post-operative ventilation support
  • patients ASA III and above
  • patients unable to use PCA due to insufficient comprehension
  • morbid obesity/ obstructive sleep apnea
  • chronic opioid or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultanah Bahiyah Hospital

Alor Seatr, Kedah, 05050, Malaysia

RECRUITING

Related Publications (1)

  • Macintyre PE, Jarvis DA. Age is the best predictor of postoperative morphine requirements. Pain. 1996 Feb;64(2):357-364. doi: 10.1016/0304-3959(95)00128-X.

    PMID: 8740614RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • lee choo yeoh, master

    CRC Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Choo Yeoh, Master

CONTACT

047722625yeohlc55@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anaesthesiologist

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 14, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

MY(1)