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

M

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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