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

NCT ID: NCT02067338

Last Updated: 2014-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Morphine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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normal saline

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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

1 mg morphine soak in epidural oxidized cellulose

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

Group Type ACTIVE_COMPARATOR

1 mg morphine soak in epidural oxidized cellulose

Intervention Type DRUG

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

Interventions

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1 mg morphine soak in epidural oxidized cellulose

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

Intervention Type DRUG

normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Siriraj hospital

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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SI 387/2012

Identifier Type: -

Identifier Source: org_study_id

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