NCT02067338

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

February 9, 2014

Last Update Submit

February 18, 2014

Conditions

Morphine

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Study Arms (2)

normal saline

PLACEBO COMPARATOR

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

Drug: normal saline

1 mg morphine soak in epidural oxidized cellulose

ACTIVE COMPARATOR

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

Drug: 1 mg morphine soak in epidural oxidized cellulose

Interventions

1 mg morphine soak in epidural oxidized celluloseDRUG

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

1 mg morphine soak in epidural oxidized cellulose
normal salineDRUG

During posterior lumbar spinal surgery , patients received NSS -soaked in epidural oxidized cellulose.

normal saline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 Yrs
  • Good orientation and communication

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2014

First Posted

February 20, 2014

Study Start

August 1, 2012

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations

TH(1)