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

Morphine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067338
• Other study ID #: SI 387/2012
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2014
• Last updated: February 18, 2014
• Start date: August 2012
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morphine
• Pain, Postoperative

Intervention

Drug:
• 1 mg morphine soak in epidural oxidized cellulose
During posterior lumbar spinal surgery , patients received 1 mg morphine-soaked in epidural oxidized cellulose.
• normal saline
During posterior lumbar spinal surgery , patients received NSS -soaked in epidural oxidized cellulose.

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes