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Clinical Trials/NCT06316921
NCT06316921CompletedNot Applicable

Effect of Epidural Patient-controlled Analgesia on Postoperative Pain After Lumbar Spinal Surgeries

Taipei City Hospital1 site in 1 country209 target enrollmentStarted: June 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
209
Locations
1
Primary Endpoint
Pain degree

Study Overview

Brief Summary

This study aimed to evaluate the effect of epidural patient-controlled analgesia (PCA) on postoperative pain relief after lumbar spine surgeries. The eligible patients received two types of postoperative pain management: PCA and standard pain treatment. Comparisons between the two groups were made in terms of postoperative pain level.

Detailed Description

This study included patients who underwent lumbar spine surgeries for degenerative spinal disease. The eligible patients were divided into two groups, the PCA group and the control group, for two types of postoperative pain management. The patients in the PCA group received 72-hour epidural PCA. The PCA catheter was inserted by the surgeon prior to wound closure in the lumbar spine surgery. The PCA catheter was maintained until 72 hours after the surgery and was removed at the postoperative day 4. The control group received postoperative standard pain treatment, including oral acetaminophen and muscle relaxants. No non-steroidal anti-inflammatory drugs were given in this study. All patients were provided the option to request intramuscular morphine injection (0.5 mg of morphine) for additional pain control, with a minimum interval of 6 hours between doses. Pain assessment was conducted using a visual analogue scale on the first four postoperative days and on the day of discharge. At the postoperative day 4, pain assessment was performed before the PCA removal. The level of pain and the number of morphine injections were compared between the two groups.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age greater than 60 years
  • Having lumbar spine surgeries for degenerative spinal stenosis, spondylolisthesis, herniated intervertebral disc, or osteoporotic spinal fracture with spinal stenosis

Exclusion Criteria

  • Spinal infection (e.g., tuberculosis, epidural abscess, and vertebral body osteomyelitis
  • Iatrogenic cerebrospinal fluid leakage or dura tear during surgery
  • Spinal tumor or spinal metastasis
  • Having minimally invasive procedures with the bilateral paramedian approach

Outcomes

Primary Outcomes

Pain degree

Time Frame: Postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, and the day of discharge (up to 1 month)

Pain degree was assessed using a visual analogue scale the on the first four postoperative days and on the day of discharge.

Secondary Outcomes

  • The number of morphine injections(The day of discharge (up to 1 month))

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Hsin-Chang, Chen

Attending staff of the Department of Orthopedics,

Taipei City Hospital

Study Sites (1)

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