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Epidural Low Dose Morphine in Postoperative Pain After Posterior Lumbar Spinal Surgery

Primary Purpose

Morphine

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
1 mg morphine soak in epidural oxidized cellulose
normal saline
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morphine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age > 18 Yrs
  • Good orientation and communication

Exclusion Criteria:

  • opioids or sulfonamides allergy
  • Contraindication for use
  • Epidural morphine
  • Selective COX 2 inhibitor
  • Patient-controlled analgesia (PCA)
  • ASA class > 3
  • BMI ≥ 35 kg/sq.m.
  • Preoperative use of opioids within 6 Wks
  • Intraoperative bleeding > 1000ml

Sites / Locations

  • Siriraj hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

normal saline

1 mg morphine soak in epidural oxidized cellulose

Arm Description

During posterior lumbar spinal surgery,one group of patient received normal saline soaked collagen sponge.

During posterior lumbar spinal surgery ,Another group of patients received 1 mg morphine-soaked in epidural oxidized cellulose.

Outcomes

Primary Outcome Measures

VAS measurement was recorded at twenty-four hour after posterior lumbar spinal surgery then compare VAS between low-dose 1 mg morphine-soaked microfibrillar collagen sponge method with normal saline soked

Secondary Outcome Measures

Full Information

First Posted
February 9, 2014
Last Updated
February 18, 2014
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02067338
Brief Title
Epidural Low Dose Morphine in Postoperative Pain After Posterior Lumbar Spinal Surgery
Official Title
The Effect of Epidural Low-dose Morphine-soaked Microfibrillar Collagen Sponge in Postoperative Pain Control After Posterior Lumbar Spinal Surgery: a Randomized, Double-blind, Placebo-controlled
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in postoperative pain control after posterior lumbar spinal surgery: a randomized, double-blind, placebo-controlled study

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
During posterior lumbar spinal surgery,one group of patient received normal saline soaked collagen sponge.
Arm Title
1 mg morphine soak in epidural oxidized cellulose
Arm Type
Active Comparator
Arm Description
During posterior lumbar spinal surgery ,Another group of patients received 1 mg morphine-soaked in epidural oxidized cellulose.
Intervention Type
Drug
Intervention Name(s)
1 mg morphine soak in epidural oxidized cellulose
Intervention Description
During posterior lumbar spinal surgery , patients received 1 mg morphine-soaked in epidural oxidized cellulose.
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
During posterior lumbar spinal surgery , patients received NSS -soaked in epidural oxidized cellulose.
Primary Outcome Measure Information:
Title
VAS measurement was recorded at twenty-four hour after posterior lumbar spinal surgery then compare VAS between low-dose 1 mg morphine-soaked microfibrillar collagen sponge method with normal saline soked
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 Yrs Good orientation and communication Exclusion Criteria: opioids or sulfonamides allergy Contraindication for use Epidural morphine Selective COX 2 inhibitor Patient-controlled analgesia (PCA) ASA class > 3 BMI ≥ 35 kg/sq.m. Preoperative use of opioids within 6 Wks Intraoperative bleeding > 1000ml
Facility Information:
Facility Name
Siriraj hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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Epidural Low Dose Morphine in Postoperative Pain After Posterior Lumbar Spinal Surgery

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