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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Morphine

Treatments: Drug: 1 mg morphine soak in epidural oxidized cellulose; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02067338

SI 387/2012

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 2 patient groups, including a placebo group

normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: normal saline

1 mg morphine soak in epidural oxidized cellulose

Active Comparator group

Description:

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

Treatment:

Drug: 1 mg morphine soak in epidural oxidized cellulose